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Concept Pharmaceuticals Ltd Report of In-Plant Training . Millennium Institute Management. 1 Important Guys These Projects Are For Your Reference Only. You Supposed To Make It By Your Own. If Any one got any of Doubt that U Just Completed Your Project By Just Copying And Pasting From These Projects Then This Is Violation Of My Restrictions. So Please Use U R Mind Before Using It Right Away. Thanking You

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Page 1: MBA Projaet-Concept Pharmaceuticals Limited

Concept Pharmaceuticals Ltd Report of In-Plant Training

. Millennium Institute Management. 1

Important

Guys These Projects Are For Your Reference Only. You Supposed To Make It By Your Own. If Any one got any of Doubt that U Just Completed Your Project By Just Copying And Pasting From These Projects Then This Is Violation Of My Restrictions. So Please Use U R Mind Before Using It Right Away. Thanking You

Page 2: MBA Projaet-Concept Pharmaceuticals Limited

Concept Pharmaceuticals Ltd Report of In-Plant Training

. Millennium Institute Management. 2

TABLE OF CONTENT

INTRODUCTION

PERSONNEL DEPARTMENT

PRODUCTION DEPARTMENT

PURCHASE DEPARTMENT

QUALITY CONTROL DEPARTMENT

QAUALITY ASSURANCE DEPARTMENT

MARKETING DEPATMENT

SWOT ANALYSIS

CONCLUSION

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Concept Pharmaceuticals Ltd Report of In-Plant Training

. Millennium Institute Management. 3

INTRODUCTION

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Company Profile 1. GENERAL INFORMATION 1.1 The firm is titled as Concept Pharmaceuticals Limited.

The Registered Office of the firm is located at 167,CST ROAD SANTACRUZ (EAST) MUMBAI 400 098 INDIA 1.2 The firm is manufacturing various dosage forms for Indian Market as well as

Export market. 1.3 The manufacturing activities are being carried out at Factory located at

Aurangabad (Maharashtra State ). Food & Drug Administration has given licence to the firm to manufacture for sale various dosage forms viz Tablets, Capsules , Dry powders , Liquid Orals External preparations, injectables , Animal Health Products and Ampicillin Sodium Sterile Bulk Drug.

1.4 Factory is located at Concept Pharmaceuticals Limited A-28/3, MIDC Area, Chikalthana, Aurangabad - 431 210. Maharashtra State. Ph.No. 0240 - 2485 671 / 2485 071 Fax 0240 - 2484 240 Email [email protected] 24 hours Telephone No. 2485 671 (Office) Person to be contacted : Mr.S.A.Shaikh Designation : GM-Q.A./ R & D

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1.5 Following type of products are being manufactured at this site

Tablets - coated & uncoated Capsules Dry Syrups Liquid Orals External Preparations (Ointments , Creams ) Liquid and Powder Injectables. Ayurvedic Products Animal Health Products. No toxic or hazardous products are being manufactured at the site. 1.6 The site is located on MIDC plot bearing No. A-28/3 in Chikalthana Industrial

Area of Aurangabad (MS). The total area of the plot is 2.24 Hectors. The immediate environment of the site is

free from pollution. The units located on adjacent plots are not generating any pollutants, fumes gases etc. The site is holding a consent from Maharashtra Pollution Control Board, a Statutory body monitoring environmental air and water pollution.

1.7 Following number of employees are engaged on site to carry out various

operations Production 117 Quality Control 017 Quality Assurance 005 Stores and Distribution 014 Engineering 013 R&D Formulation 005 R&D Bulk Drugs 016 Personnel & Admn. 012 Factory Management Team 002 ------------- Total 201 =======

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1.8 The Quality Assurance Dept/ Quality Control Dept located at site is well equipped to carry out all the required analytical work. At instances, assistance from Govt. approved Public Testing Laboratories is also taken, when facilities to carry out specific tests are not available on site.

In such cases we normally use services of Name and Address of the Laboratory : 1) M/s. Bee Pharmo Labs Pvt.Ltd. 5-6-7 Kakad Estate, R G Thadani Marg, Worli, Mumbai 400 018, Mumbai.

2) Manisha Analytical Laboratories Pvt. Ltd. 135 A, Govt. Industrial Estate, Charkop, Kandivali (West), Mumbai –400060, Tel- 2869 9888, 28602292 Fax- 2869 5296. E-mail – [email protected] Website-WWW.manishalab.com 1.9 Concept is well equipped for manufacturing Quality goods. Its Quality Control

and manufacturing Dept. are having all the required facilities for ensuring the desired and consistent quality of all the produces. We therefore, have well-designed system of Quality Assurance incorporating GMP & Quality Control. It is being monitored effectively and documented.

1.9.1. All the incoming raw materials are procured from approvedvendors. These inputs are subjected to stringent and thorough Quality Checks prior to releasing them for manufacturing.

1.9.2 .There is a well designed inprocess checks system to monitor the manufacturing stages in order to ensure desired and consistent Quality of the products being manufactured.

1.9.3. The samples are withdrawn for final checks by quality control and only after confirming the total compliance the batches are released for market.

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1.9.4. All the operating procedures are standardised validated and well documented. These standard procedures are strictly followed during the total operations and a record is maintained to that effect.

1.9.5. All the Machinery, Equipment’s, Instruments used for processing and Quality checks are subjected to periodic calibrations.

1.9.6. The workforce is well trained to carry out the manufacturing activities in the prescribed manner. Their knowledge is updated through periodic training programmes.

1.9.7. All the manufacturing and analysis activities are carried out under the direct

supervision of team of Technically Competent Persons. \

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ABOUT THE ORGANIZATION

Concept was launched as an independent entity in 1984 by Shri A. B. Gupta who had earlier experience as founder director of Lupin Group of Companies. Initially launched as a marketing company it has expanded its activitities to emerge as a strong multi-divisional group with excellent infrastructure. Its activities include: Ethical Pharmaceutical : Covers around 60% of all the therapeutic groups has launched a number of innovative products. Animal Health Division : Is one of the top 10 domestic companies in this area. APIs Division : Infrastructure and knowledge base in manufacturing sterile and non sterile products. Herbal Division: Innovative herbal products to treat lifestyle conditions. Institution & hospital division :Caters to the needds of large public institutions as well as private hospitals. Medical electronics : Handling range of critical care products such as Cardiac Monitors, Treadmills, Oximeters etc. These activities are supported with a strong infrastructure such as 5 manufacturing plants, 17 branch offices/distribution centres, 400 strong marketing force throughout the country meeting 50,000 doctors every month supported by a network of around 1000 stockists. In addition the company is putting lot of thrust towards R&D efforts and has successfully launched few technologies, first time in the country through its own government approved R&D centres. Our Pharmaceutical marketing covers majority of the therapeutic areas. We have a strong and well trained field force of more than 350 personnel which cover more than 60,000 doctors every month.

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We enjoy leadership position in the pediatric Anti-Tubercular market. While competitors in this therapeutic segment concentrate only on cure of infection, Concept goes beyond cure of infection by focusing on improved quality life of patient, through B6 safeguard against peripheral neuropathy and convenience of administration. Concept was the first company in the world to introduce Oflab the combination of Ofloxacin and Lactobacillas. This innovation is welcomed by medical professions as and is used to make the patient feel better because Lactobacillas takes care of the abdominal discomfort normally experienced by patient on Ofloxacin. Concept also has a strong position in the cephalosporin market. Mission and Strategy "We will discover, develop and successfully market pharmaceutical products to prevent, diagnose, alleviate and cure diseases. We shall provide total customer satisfaction and achieve leadership in chosen markets, products and services across the globe, through excellence in technology, based on world-class research and development. We are responsible to the society. We shall be good corporate citizens and will be driven by high ethical standards in our practices." " Is to provide products of international quality for better health care of Livestock and Poultry, at most economical price so that farmers can earn higher profits due to improved productivity " Code of Conduct As required under revised Clause 49 of the Listing Agreement the following code of conduct has been approved by the Board of Directors and is applicable to the Directors and Senior Management of the Company. Ethical conduct All directors and senior management employees shall deal on behalf of the Company with professionalism, honesty, integrity as well as high moral and ethical standards. Such conduct shall be fair and transparent and be perceived to be as such by third parties.

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Conflict of interest Any director or senior management employee of the Company shall not engage in any business, relationship or activity, which might detrimentally conflict with the interest of the Company. Transparency All directors and senior management employees of the Company shall ensure that their actions in the conduct of business are totally t ransparent except where the needs of business security dictate otherwise. Such transparency shall be brought about through appropriate policies, systems and processes. Legal compliance All directors and senior management employees of the Company shall at all times ensure compliance with all the relevant laws and regulations affecting operations of the Company. They shall abreast of the affairs of the Company and be kept informed of the Company's compliance with relevant laws, rules and regulations. In the event that the implication of law is not clear, the course of action chosen must be supported by eminent legal counsel whose opinion should be documented. Rightful use of company’s assets All the assets of the Company both tangible and intangible shall be employed for the purpose of conducting the business for which they are duly authorized. None of the assets of the Company should be misused or diverted for personal purpose. Cost consciousness All the directors and senior management employees of the Company should strive for optimum utilization of available resources. They shall exercise care to ensure that costs are reasonable and there is no wastage. It shall be their duty to avoid ostentation in Company expenditure.

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Confidential information All directors and senior management employees shall ensure that any confidential information gained in their official capacity is not utilized for personal profit or for the advantage of any other person. They shall not provide any information either formally or informally to the press or to any other publicity media unless specifically authorized to do so. They shall adhere to the provisions of SEBI (Prohibition of Insider Trading) Regulations, 1992. Relationships with Suppliers and Customers The Directors and senior management employees of the Company during the course of interaction with suppliers and customers, shall neither receive nor offer or make, directly and indirectly, any illegal payments, remuneration, gifts, donations or comparable benefits which are intended or perceived to obtain business or uncompetitive favours for the conduct of its business. However this is not intended to include gifts of customary nature. Interaction with Media The Directors and senior management employees other than the designated spokespersons shall not engage with any member of press and media in matters concerning the Company. In such cases, they should direct the request to the designated spokespersons. Safety and Environment The Directors and senior management employee shall follow all prescribed safety and environment-related norms.

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Pharmaceutical Division It is the core activity with strong thrust for ethical marketing. It has a strong presence in the therapeutic group such as

1. Anti-tubercular 2. Antibiotics 3. Antacids & Antiulcerants 4. Cough preparations 5. Analgesic & Anti-inflammatory drugs 6. Cardiovascular drugs.

The company has successfully launched quite a few products for the first time in the country as a result of innovative ideas through R&D efforts Range of pediatric dispersible tablets. Rifa I-6 kid & Rifa I-kidforte -- combination of Rifampicin, Isonaizide & Vitamin B6. Roxyrol 50 & 75 mg -- Roxythromycin 50 & 75 mg. Ibuplus kid – Ibuprofen plus Paracetamol. Fluzide 50 mg D.T – Fluconazole 50 mg (D.T) Disogel – only antacid with cyto protective DGL. Clarex – herbal anti acne cream. Ajar – herbal antioxidant, immunomodulator & antidepressant.

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Registered in centers such as

1. Africa :

Ghana Nigeria Sudan Kenya Ethiopia Uganda Zambia

2. Asia :

Srilanka Myanmar Cambodia Singapore Malaysia Philippines Thailand

3. C.I.S. Countries :

Ukraine

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MANAGERIAL TEAM OF CONCEPT PHARMACEUTICAL LIMITED

Mr. A.B. GUPTA – Chairman and Vice President Personnel Department : Mr. S.U. Joshi – HRD Manager Mr. A.H. Baghwan – Executive Officer Finance Department : Mr. Kamlesh Kurani – General Manger Mr. Katare – Executive Officer Production Department : Mr. M.M. Atre – Vice President Mr. S.A. Shaikh – General Manager Mr. J.P. Lal – Deputy General Manager Mr. M.G. Umapurkar – Executive Officer Mr. S. Bakal – Executive Officer Marketing Department : Mr. Ajay Kumar – Vice President Mr. Amit Vyas – Product Manager Mr. Deepak Parab – RSM Mr. S.K. Gupta – ASM QA Department : Mr. V.L. Pathak – Manager Mr. Pravin Mewade – Senior Executive Officer QC Department : Mr. S.J. Koshti – Manager Mr. D.M. Shastri – Senior Executive Officer

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ABBREVATIONS USED IN MODULAR PLAN

1. R.D (F.C.) = Research & Development Department (Fine Chemicals) 2. INT = Instrument room 3. R.D.(F) = Research & Development Department (Formulation) 4. ENT = Entrance 5. QA = Quality Assurance Department 6. PDN CAB = Production Department Cabin 7. EDP = Electronic Data Processing Department 8. C.R. = Change Room 9. CAN = Canteen 10. W = Way 11. I.P.Q.C = In Process Quality Control 12 Q.C = Quality Control Department 13. T = Toilet 14. BSR = Bonded Storage Room 15. STR = Store 16. OINT = Ointment Production Room 17. GRA = Granulation Area 18. COM = Compression Area 19. DSF = Dry syrup Filling Area 20. COA = Coating Area 21. CAP = Capsule Production Department 22. PAR = Parentaral Department 23. BULK = Bulk Department 24. PKG = Packing Department 25. LQD = Liquid Oral Department 26. C = Cabin

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PRODUCT LIST

Some of the examples of the products are given:

1) ANTI-TB RANGE

PRODUCTS DETAILS RIFACEPT3 3 drug anti T.B therapy RIFA 1-6 FORTE For adults above 50 kg body weight RIFA 1-6 For adults unto 50 kg body weight RIFA 1-6 KID FORTE Childhood T.B with Vitamin B6 f0r 20 kg

body weight RIFA 1-6 KID Childhood T.B with Vitamin b6 for 10 kg

body weight RIPECEPT KID3 First 3 drugs anti T.B with Vitamin B6 for

childhood tuberculosis.

2) GASTRO-INTESTINAL PRODUCTS DETAILS DISOGEL SYRUP For acid peptic disorder DISOGEL TABLETS ,, PANTEC 20 Pantoprazole delivered at duodenum 3) COUGH SYRUPS PRODUCTS DETAILS SYNABORN TABLETS Clears blockade fast & ends cough

completely SYNABRON TABLETS Ends the cough completely SYNABRON M For total reform cough & cold SYNABRON D Stops cough & cold.

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4) HERBAL PRODUCTS DETAILS AJAR CAPSULES Spirulina potentiated stress bluster CLAREX CREAM Cleans pimples, better complexion HEPACEF SYRUP Keeps liver safe HEPACEF TABLETS Keeps hepa safe. 5) ANTI-BACTERIALS PRODUCTS DETAILS ROXYROL 50 Dispersible Roxythromycin for age 5 yrs BROMOXYL Awaiting punch line ROXYROL 75 Dispersible Roxythromycin for age 5-12

yrs. 6) ANTI-FUNGAL PRODUCTS DETAILES FLUZIDE 200 Eradicates fungi FLUZIDE 150 Treatment for any fungi FLUZIDE T In mixed vaginitis FLUCREAM NM Eradicates infection in mixed skin

infections

7) CARDIOVASCULAR PRODUCTS DETAILES CARDIF Calcium blockade + beta blockade CARDIF BETA ,, ASPICOT 80 Enteric coated aspirin for anti-platelet

activities LPL 10 Most preferred ACE inhibitor LPL 2.5 ,,

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8) ANTI-INFLAMMATORY PRODUCTS DETAILES IBUCON KID Faster activity antipyretic IBUCON PLUS Faster acting antipyretic IBUCON 200 PLUS For tender stomach IBUCON 400 Extra power anti-inflammatory analgesic 9) ANIMAL HEALTH PRODUCTS

PRODUCTS DETAILES PEPSID, LEPTAMILK Tonics PYRENIL Faster acting antipyretic CURADEX Anti-inflammatory CONAMPI Antimicrobial

GENERIC DIVISION

1) ANTIBIOTICS BRAND INGREDIENTS QTY C-MOX Amoxicillin 250/500 mg Capsule GENCIN Gentamicin 10ml/30ml Injection CEPHACON Cephalexin 125/250 mg kid tablet 2) ANTIBACTERIALS BRAND INGREDIENTS QTY ULTIFLOX Ciprofloxacin 250/500 mg tablet COPRIME Cotrimoxazole 60 ml suspension

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3) ANTI T.B RANGE

BRAND INGREDIENTS QTY RIFACON Rifampicin

Isoniazid 450 mg 300 mg Capsule

ULTICOX Ethambutol 800 mg Tablet

4) NUTRACEUTICALS BRAND INGREDIENTS QTY MEGASULES High dose B-complex &

Vit-C Capsule

SAMVIT Multivitamin Capsule 5) COUGH & COLD BRAND INGREDIENTS QTY KONCIDRYL Diphenhydramine 100 ml cough syrup 6) ANTIDIARRHOEALS BRAND INGREDIENTS QTY NORE-T Norfloxacin 400 mg tablet CONCIZOLE Metronidazole 200 mg& 400 mg tablet 7) ANTI-ULCERANTS BRAND INGREDIENTS QTY RANCAFE Ranitidine 150 mg tablet/injection

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MANUFACTURING PLANTS Three manufacturing plants covering all type of dosage forms approved for

G.M.P as per W.H.O standards since 1992. Aurangabad (Chikalthana) plant located 5 km from city. Land of around 15 acres

with manufacturing facility of around 1,00,000 square feet. Here the majority of production for Concept Pharmaceuticals Ltd is done . Plants have Drug dosage forms such as Tablet, Capsule & Dry syrup.

Aurangabad (Chittegaon) 10 km from city center on Paithan road. Around 10

acres. Manufacturing facility of 20,000 square feet. Here the majority of production is of Rifampicin (Anti Tuberculosis drug) is been carried out.

Birganj (Nepal) plant on the main highway connecting Birganj to Kathmandu

about 5 km from Birganj. The first plant to be approved for W.H.O & G.M.P standards in Nepal.

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PERSONNEL DEPARTMENT

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House Keeping

1. Objective : To provide standing operating procedure for good house keeping to facilitate

Manufacturing operations in orderly manner

Cleaning and disinfection of the premises Maintenance of the clean and hygienic environment for working.

2. Scope : This is applicable to plant and premises 3. Responsibility : House keeping incharge is responsible for the house keeping of

the total premises

4. Procedure : Place dust bins at all appropriate and required locations duly labeled as “Dust Bins”. Remove dust bins and empty it at fixed intervals.

Ensure insectocutors at all the appropriate and required points are working. Collect trays of such insectocutors and empty it periodically. Ensure fire fighting equipments of appropriate type at all the required locations. Refill such equipments periodically and maintain the record. Provide door mats at all the required exits and entries. Demark predetermined places for storage of different places for storage of different categories of materials and accordingly put the materials there only. Pull all the waste collected from various locations at point and then dispose of as per the procedure given under the SOP titled as “Waste Disposal”.

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TRAINIG AND DEVELOPMENT OF PLANT PERSONNEL

1. Objective : To lay down the standard operating procedure for training of all plant

personnel.

2. Scope : All employees of the factory.

3. Responsibility : HRD manager is responsible for the training and development of plant personnel.

4. Procedure : The following procedure is followed for training and development of

employees. Training needs of the employees are identified from the performance appraisals of the employees and through observations of the chief of the plant.

Assess the training needs of the employees and prepare the training calendar for all employees of the company. Organize the training programmes with the help of the internal as well as external resources. Maintain the record of each internal programme conducted .

Maintain the record of training of each employee as in from T1.

Send employees for training / seminars and workshops etc. organized by the external professional agencies.

Evaluate each of such training program internally conducted in form T3.

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JOB DESCRIPTION AND MANAGEMENT RESPONSIBILITIES OF TECHNICAL PERSONS

1. Objective : To provide job description and management responsibilities of

technical persons. 2. Scope : Applicable to job responsibilities of all senior technical persons.

3. Responsibilities : HRD Manager.

4. Procedure : The job responsibilities of all senior technical persons are to be

written down as the same is essential for smooth, error free working, to make the person responsible / accountable for the particular activity. Well defined job responsibilities avoid confusion in working and everybody becomes aware his own area of work.

A. Vice President

The person reports to Chairman and Managing Director. He is overall responsible for the following functions : A.1. Overall functioning of the factory A.2. Co-ordination between various section heads at Head Office And Factory A.3. Production of all dosage forms A.4. Commercial activities A.5. Engineering services A.6. Stores services A.7. Distribution services A.8. Overall factory administration Following officials reports to Vice President : A.1. Deputy General Manger – Engineering Operations A.2. Deputy General Manger – Manufacturing A.3. General Manger – Q.A and R&D A.4. Manager – Q.C. A.5. Senior Manager – Formulation Development (Herbal) A.6. Manager – Commercial A.7. Deputy General Manager (HR & Adm)

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Deputy General Manager – Engineering Operations The person reports to Vice President of the Organisation. The members of Engineering team shall be reporting to him. The person is responsible for :

1. Planning of day to day activity 2. Maintenance of equipments, machineries, utilities provided for manufacturing 3. Designing and implementing of preventive maintenance schedule 4. Attending break down maintenance calls 5. Procurement of right equipment and installation of new machineries 6. Monitoring and maintenance of energy sources 7. Maintenance of pollution free atmosphere 8. water treatment and discharge of effluents 9. Liaisoning with government bodies i.e., Electricity Board, Boiler Officers, MPCB 10. Planning timely commissioning of projects.

Deputy General Manager – Manufacturing DGM – Mfg, Reports to Vice president of the Organisation. The members of production team report to him. The person s responsible for :

1. Preparation of the monthly production schedule carrying out of production activities as per the plan

2. Manufacturing of the product as per the SOP’s to achieve the specified yield and quality norms

3. Maintenances of the batch manufacturing records 4. Following of GMP requirements 5. Upkeeping of the equipments, area and other facilities 6. Training and development of employees working in production 7. Packing of all the dosage form as per the standard packing procedure.

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General Manager – QA and R&D The person reports independently to Vice President of the factory. The person is responsible and authorized for QA and R&D functions All the members of QA sand R&D team report to him The person is responsible for: (Q.A responsibilities)

1. Approving or rejecting all the procedures of specifications impacting on the identity, strength, quality and purity of the drug products 2. Review of production records to assure that no errors have occurred during manufacturing of the product or if errors have occurred, that they have been fully investigated 3. Implementation of all the requirements of good manufacturing practices and good laboratory practices 4. Attending the market complaints, investigation thereof, and implementation of corrective steps 5. Recall of the products found to be not of standard quality 6. Liaisoning with FDA.

Formulation Development : The person is responsible for development of new products, improvements of existing products. All the members of R&D team report to him. The person is responsible for :

1. Development of new products 2. Designing the specifications for raw materials, packing materials, semi finished

products and finished products 3. Designing the standard manufacturing procedure for manufacturing of the

products 4. Validation of process equipments and processes.

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Manager Quality Control : Approval or rejection of all raw material inputs, packaging material inputs, inprocess materials and finished products manufactured, processed, packed or held under contract by another company. Sr.Manager – Formulation Development (Herbal) The person reports to General Manager QA and R&D The person is responsible for the development of new products, improvement of existing products. The person is responsible for :

1. Development of new products 2. Designing the specifications for raw materials, packaging materials, semi finished

products and finished products 3. Designing the standard manufacturing procedure for manufacturing of the

products 4. Validation of process equipments and processes.

Manager-- Commercial The person reports to the Vice President of the factory. The team of purchase, accounts, distribution reports to him. The person is responsible for :

1. Purchasing of consumables, engineering spares, utility items and corrugation as per the need from approved vendors

2. Maintenance of accounts, banking services 3. Compliance with various taxations including excise, sales tax, income tax 4. Liaisoning with the govt. agencies regulating the various taxes 5. Receipt, identification and storage of all the raw material and packing materials 6. Storage of materials under specified conditions of storage 7. Handling of the materials as per their release status 8. Dispensing of the materials to production dept. 9. Maintenance of inventory records 10. Following of FIFO system in issuance of the materials 11. Return of the rejection materials 12. Destruction of the obsolete materials 13. Upkeeping of area, equipments and facilities 14. Following of GMP requirements 15. Receipt of finished goods from packing dept. 16. Storage of finished goods under appropriate conditions of storage 17. Dispatches of finished good to various depots as per dispatch plan 18. Following of FIFO system in dispatching the goods 19. Maintenance of all the system and control records.

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Deputy General Manager – HR & ADMIN. The person reports to the Vice President of the factory. The team of HR & Admin. Dept, security staff reports to him. The person is responsible for : 1. Manpower planning of the factory 2. Identification and fulfilling the manpower requirements of various sections

through recruitments 3. Identification & fulfilling training needs of various personnel 4. Security & safety of the plant, machineries & personnel] 5. Maintenance of hygiene in the factory premises 6. Cleaning, maintenance & sanitation of the plant & premises 7. Providing canteen services to the employees 8. Liaisoning with govt. agencies 9. Organizing seminars on technical sessions & continues development of personnel 10. Effective communication inter & intra dept.

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PERSONAL HYGIENE 1. Objective :

This SOP is prepared to have laid down standard procedure for personal hygiene in order to avoid contamination, as pharmaceutical products are to be manufactured in a clean, hygienic environment. Personal hygiene therefore attains an important role in manufacturing of pharmaceutical products, & is a part of cGMP.

2. Scope : 3. This SOP is applicable to all

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PRODUCTION DEPARTMENT

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TYPES OF DOSAGE FORMS MANUFACTURED TABLETS CAPSULES

LIQUID ORALS OINTMENTS PARENTERALS

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TABLET DEPARTMENT

It is divided into: Material entry

Dispensing area

Granulation

Compression

Coating

Packing

Master files worksheet & SOP’s are maintained for each product manufactured. It contains the formula for active ingredients, test to be done on raw materials, procedure for manufacturing, test to be on final products & other information necessary for the manufacturing of each product.

The worksheet contains the materials work order, the area & the equipments clearance charts, the manufacturing procedure with theoretical yield sheet to record practical yield of granules & tablet, it also carries the Q.C reports at every step & the final release for sale sheet.

Production department also maintains yield registers of various products Stepwise, all machinery information, calibration report of equipment, production plan & reports etc. for future reference. They also standardize each sophisticated equipment like Disintegration apparatus, Electronic balance, Moisture content measurement apparatus etc. before starting the production each & every day.

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MAJOR MACHINERY AVAILABLE IN MANUFACTURING OF TABLETS DEPARTMENT

FOR GRANULATION: SL. No.

Name Of Equipment Name of the Mfgr. Qty. Capacity

1. Sifter 30” Dynamic Machine Pvt. Ltd 1 600 kg 2. Mass Mixer (200 kg Cap) Dynamic Machine Pvt. Ltd 1 200 kg 3. Planetary Mixer Beeter Machine Ltd. 1 200 kg 4. Rapid Micro Granulator SAM Machine 1 600 Ltr. 5. Paste Vessel Dynamic Machine Pvt. Ltd 1 100 Ltr. 6. Multi Mill RPM 3500 Pharma Electro 2 600 kg 7. Clit Mill Clit Machine 1 500 kg 8. Cad Mill Cadmach 1 500 kg 9. Fluid Bed Dryer Alliance Engineering Ltd. 2 100 kg 10. Octagonal Blender ESSAR 1 500 kg 11. I.P. Containers Dynamic Machine Pvt. Ltd 10 500 kg 12. Colloid Mill Dynamic Machine Pvt. Ltd 1 --- FOR COMPRESSION: SL. No.

Name Of Equipment Name of the Mfgr. Qty. Capacity

1. Cadmach DR. 35 ST’N Cadmach 1 8.4 Lakhs 2. Clit DR. 27 ST’N Clit Machine 1 5.4 Lakhs 3. Clit Press Clit Machine 1 7 Lakhs 4. Double Rotary St.

Machine (Square Body) Dynamic Machine Pvt. Ltd 1 4 Lakhs

5. Mini Rotary Machine Dynamic Machine Pvt. Ltd 1 --- 6. Double Rotary Machine Dynamic Machine Pvt. Ltd 1 3.0 Lakhs 7. Single Rotary

Compression Machine Dynamic Machine Pvt. Ltd 1 1.7 Lakhs

8. Single Rotary Compression Machine

Dynamic Machine Pvt. Ltd 1 1.21 Lakhs

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FOR COATING: SL. No.

Name Of Equipment Name of the Mfgr. Qty. Capacity

1. Coating Pan SS 48” Dynamic Machine Pvt. Ltd 1 100 kg 2. Coating Pan SS 42” Dynamic Machine Pvt. Ltd 2 100 kg 3. Coating Pan SS 36” Dynamic Machine Pvt. Ltd 2 60 kg 4. Polishing Pan SS 48” Dynamic Machine Pvt. Ltd 1 100 kg FOR PACKING: SL. No.

Name Of Equipment Name of the Mfgr. Qty. Capacity

1. Tablet Printing Machine Mangnose Engg. Co. 1 8.0 Lakhs 2. Tablet Counting Balance Microweigh 1 2400

Bags 3. Blister Pack Machine Elmac 3 6.0

Lakhs/m/c

4. Strip Sealing Machine Dynamic/Hemson 3 3.0 Lakhs/m/c

5. Electronic Balance Eagle 1 500 kg

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MAJOR MACHINERY AVAILABLE IN MANUFACTURING OF CAPSULES/DRY SYRUPS DEPARTMENT

SL. No.

Name Of Equipment Name of the Mfgr. Qty. Capacity

1. Sifter 30” Dynamic Machine Pvt. Ltd 1 400 kg 2. Mass Mixer (100 kg Cap) Dynamic Machine Pvt. Ltd 1 100 kg 3. Tray Dryer Dynamic Machine Pvt. Ltd 1 100 kg 4. Mass Mixer Dynamic Machine Pvt. Ltd 1 150 kg 5. Capsule Filling Machine PAM Pharmaceuticals Ltd.

Allied Machine Co. Ltd. Monita Industries Dynamic Machine Pvt. Ltd

2 1 1 2

0.5 Lakhs 0.5 Lakhs 0.5 Lakhs 0.5 Lakhs

6. Capsule Counter Dynamic Machine Pvt. Ltd 4 0.5 Lakhs 7. Semiautomatic Capsule

Filling Machine PAM Machine 1 1.44 Lakhs

8. Semiautomatic Capsule Sealing Machine

Master Mechanical Works Ltd.

2 0.1 Lakhs

9. Belt Polishing Machine Pharma Chem India 1 1.5 Lakhs 10. Air Conditioner Pharma Chem India 2 --- 11. Dehumidifier Indian Equipment

Corporation 2 ---

12. Electronic Balance Mettler Machine 1 300 gm

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MAJOR MACHINERY AVAILABLE IN MANUFACTURING OF LIQUID ORAL DEPARTMENT

SL. No.

Name Of Equipment Name of the Mfgr. Qty. Capacity

1. Bulk Manufacturing & Storage S.S Tanks

a) 6000 Ltr. Cap b) 3500 Ltr. Cap c) 3000 Ltr. Cap d) 1000 Ltr. Cap e) 300 Ltr. Cap f) 100 Ltr. Cap g) 200 Ltr. Cap h) 1500 Ltr. Cap

Dynamic Machine Pvt. Ltd. Dynamic Machine Pvt. Ltd. Dynamic Machine Pvt. Ltd. Dynamic Machine Pvt. Ltd. Dynamic Machine Pvt. Ltd. Dynamic Machine Pvt. Ltd. Dynamic Machine Pvt. Ltd. Dynamic Machine Pvt. Ltd.

1 1 1 1 1 1 1 1

6000 Ltr. 3500 Ltr. 3000 Ltr. 1000 Ltr. 300 Ltr. 100 Ltr. 200 Ltr. 1500 Ltr.

2. Portable Stirrer Dynamic Machine Pvt. Ltd 1 --- 3. Stirrer Dynamic Machine Pvt. Ltd 2 --- 4. Filter Press Magumps Pvt.Ltd. 1 6000 Ltr. 5. Colloid Mill Cadmach 1 6000 Ltr. 6. Transfer Pumps Dynamic Machine Pvt. Ltd 1 6000 Ltr. 7. Bottle Washing Machine Dynamic Machine Pvt. Ltd 1 36000

bottles/hr 8. Six Head Bottle Filling

Machine Dynamic Machine Pvt. Ltd 1 30000

bottles 9. Two Head Liquid Filling

Machine Dynamic Machine Pvt. Ltd 1 30000

bottles 10. Semi Auto Sealing

Machine (Crown Cap) Dynamic Machine Pvt. Ltd 1 3000

bottles 11. Automatic Sealing

Machine Automat 1 40000

bottles 12. Inspection Hood Dynamic Machine Pvt. Ltd 2 --- 13. Ambica Labeling

Machine AMBICKA 1 40000

bottles 14. Carry Strap Machine NOBEL 2 1200 boxes

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MAJOR MACHINERY AVAILABLE IN MANUFACTURING OF OINTMENT DEPARTMENT

SL. No.

Name Of Equipment Name Of the Mfgr. Qty. Capacity

1. S.S. Jacketed Pan with Planetary Type Mixing arrangement & built in homogenizing arrangements

Dynamic Machine Pvt. Ltd. 1 250 kg

2. Automatic Ointment Filling Machine (Tube)

Prechitech Bombay 1 1200 tubes

3. Mixing & Storage Tank Dynamic Machine Pvt. Ltd. 2 200 kg 4. Crimping Machine Dynamic Machine Pvt. Ltd. 1 --- 5. Vacuum Cleaning Machine Dynamic Machine Pvt. Ltd. 1 --- 6. Electronic Balance ATCO MAKE 1 500 gm

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MAJOR MACHINERY AVAILABLE IN MANUFACTURING OF INJECTION DEPARTMENT

SL. No.

Name of Equipment Name of the Mfgr. Qty. Capacity

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13.

Hot Air Sterilizer Dry Heat Sterilizer Steam Sterilizer Ampoule/Washing Machine Distilled Water Unit a) Vial Washing Machine b) Vial Washing Machine Bung Washing Machine Pressure Vessels

a) 200 Ltr. Capacity b) 100 Ltr. Capacity c) 20 Ltr. Capacity d) 5 Ltr. Capacity

Pressure Vessels

a) 200 Ltr. Capacity b) 50 Ltr. Capacity c) 20 Ltr. Capacity

Two Head Vial Filling Machine Ampoule Filling & Sealing Machine 50 Ltr. SS Cans 20 Ltr. Glass Corboy

Dynamic Machine Pvt. Ltd. Dynamic Machine Pvt. Ltd. Lance Engineers Co. Dynamic Machine Pvt. Ltd. Lance Engineers Co. P.S.E Harsiddhi Excel Dynamic Machine Pvt. Ltd. Dynamic Machine Pvt. Ltd. Dynamic Machine Pvt. Ltd. Dynamic Machine Pvt. Ltd. United Engineers Ltd. United Engineers Ltd. United Engineers Ltd. Dynamic Machine Pvt. Ltd. United Engineers Ltd. ---- ----

1 1 1 1 1 1 1 2 1 2 1 1 2 2 2 1 1 5 2

--- --- --- 80/min 150/Ltr.hr. 80 vial/min 80 vial/min 7000/hr --- --- --- --- --- --- --- 40 vial/min 52ampoule/min --- ---

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14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29.

25 Ltr. Pressure Vessels Vial Cap Sealing Machine Liquid Filling Machine Double Stroke Vial/Ampoule Labeling Machine Dry Powder Filling Machine Amber Volumetric Powder Filling Machine Vial Labeling Machine Plugging Machine Aluminium Cap Sealing Machine Rubber Plugging Machine Aluminium Sealing Machine Double Cone Blender (10kg) Split A/c Air Module

a) Laminar Air Flow b) Laminar Air Flow c) Laminar Air Flow

Clean Air Bench

---- United Engineers Ltd. Excel Dynamic Machine Pvt. Ltd. AMBA Engg. Co. AMBA Engg. Co. AMBA Engg. Co. Excel Excel Excel Balaji United Engg Voltas. Klenzider Kirloskar Air Pack Klanzider Kirloskar

2 2 1 1 1 1 1 1 1 1 1 1 1 1 2 2 2 1

--- 40 vial/min 80 vial/min 40 vial/min 40 vial/min 80 vial/min 120 vial/min 80 vial/min 120 vial/min 80 vial/min 120 vials/min 8 kg/hr. --- --- --- --- --- ---

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30. 31. 32. 33. 34. 35. 36. 37. 38. 39. 40. 41. 42. 43. 44. 45. 46. 47.

Pressure Vessels S.S. Candel Filter Filter Press Unit Inspection Hood Air Handling Unit Vacuum Pumps Refrigerators Bubble Point Apparatus Leak Test Apparatus Oven Dehumidifier Membrane Holder Electronic Blance Inspection Powder Machine Bung Dryer S.S. Trays Vial S.S. Trays Ampoules Membrane Holder

Kumar Process Engg. Kumar Process Engg. Unit Pack Dynamic Machine Pvt. Ltd. Volts ACME VAC Kelvinator Dynamic Machine Pvt. Ltd. Dynamic Machine Pvt. Ltd. Dynamic Machine Pvt. Ltd. Tropical Pharma Lab. Mettler AMBA Engg. United Pharma Electro Pharma Electro Pharma Lab.

1 1 1 1 1 1 1 1 1 1 1 3 1 1 1 770 130 1

400 Ltr. --- --- --- --- --- 165 Ltr. --- --- --- --- --- 300 gm 90 vials/min 15000 180 vials/tray 350 vails/tray ---

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SOURCES OF HEAT ENERGY Boilers are used as the source of heat energy. Capacity ---------- 1.5 tons Fuel used ---------- furnace oil The hard water from the local source is treated in ion exchange resin to remove the hardness of the water & make soft water(5ppm). Using the steam generator at high pressure of 10 kg at a temperature of 200 Deg. Cent. This water is heated & is transferred to the production area with a pressure of 5 kg & temperature of 150 Deg. Cent.

SOURCES OF ELECTRICITY MSEB ( Maharashtra State Electricity Board ) is the source of electricity. The power requirement is 500 KAV.

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SOURCES OF WATER The local source of water is MIDC ( Maharashtra Industrial Development Corporation). The water is treated before it is used in the industry. FLOW CHART SHOWING THE TREATMENT OF THE WATER: MIDC Water Water Treatment Plant ( Chlorination ) Dematerialized Water -------U.V. Unit -----Non-parental Use Distillation Parental Use

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EFFLUENT AND TREATMENT

The liquid effluents in the industry are being treated. STEP –1: At first the liquid is treated in the oil separators. This is to separate the oil contents in the liquid. STEP – 2: This is passed to a tank where air bubbling is performed. Here the effluent gases are removed from the water. This degassing is done up to 2 hours or more depending upon the effluent gas present in the liquid. STEP – 3: The process may not degas all the effluent gases present in the liquid. For this the liquid is again passed through the aerator. The aerator pumps the air in a high pressure to make a fountain of droplets of water. This will help to remove every trace of dissolved gases. STEP –4: The liquid mostly may be of altered pH. According to the type of the effluent liquid it may be treated with either acid or alkali to bring the liquid to normal pH of 7. STEP – 5: The treated water is efficiently reused for irrigation in gardens & lawns of the company.

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MAJOR MACHINERY AVAILABLE IN MANUFACTURING OF UTILITY DEPARTMENT

SL. No.

Name Of Equipment Name of the Mfgr. Qty. Capacity

1. Steam Boiler Steamslar 1 1.5 mt/hr 2. Steam Boiler Elight 1 600 kg/hr 3. Air Compression Kirloskar 1 100 CFM

7 kg/sq.cm

4. D.G. Set with Control Panel

Ashok Leyland 1 62.5 KVA

5. D.M. Water Plant Ion-Exchange 1 10 Cub. Mtr./Regeneration

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PURCHASE DEPARTMENT

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SOURCE OF RAW MATERIALS

There are all three types of sources:

Local Indigenous

Imported

SUPPLIERS LIST: Examples of some of the sources: 1. NOSCH Labs Pvt. Ltd Hyderabad 2. JAIN Acid & Chemicals Aurangabad 3. Alkyl amines chemicals Ltd. Pune 4. J.B. KHOKHANI & CO Mumbai 5. EBERS PHARMA Mumbai 6. CRYSTAL PHARMA Mumbai 7. GUJARAT Organic Ltd. Gujarat 8. UNIVERSAL CAPSULES Pvt. Ltd. Thane 9. AQUATIC REMEDIES Ahmedabad 10. SANTOSH Ayurvedic Drug Supply Mumbai SOME IMPORT SOURCES: a) NOVEON JNC U.S.A b) FEI CHING RUITAI China c) FEI CHING China

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Materials Management

The Materials Management applications must provide the NCAS with capabilities for managing and controlling the State's purchasing and accounts payable policies and accounting for the inventoried assets.

The Materials Management modules are currently integrated components of the NCAS with the exception of the Fixed Assets Module (FA). The following paragraphs by business application, portray the fully integrated process.

Overview of Current Materials Management Process

Through shared vendor and policy information, Purchasing and Accounts Payable

functions can freely communicate without the usual control issues associated with duplication of files and batch interfaces. Accounts Payable shares purchase order information from Purchasing and updates the invoiced-to-date amount on the purchase order real-time. Receipts are entered and referenced to a purchase order number, ensuring accurate posting of deliveries to each purchase order line. Receipts that cannot be identified or that do not fit matching criteria are identified, placed on hold, and reported for buyer action. Each receipt is checked for proper delivery points and verified that the quantities received and the receipt date are within tolerances already defined on the purchase order. Another receipt requirement, inspection of goods, is handled through dock-to-stock tracking. This feature tracks the inspection of materials according to a table of routing and inspection areas.

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Accounts Payable performs the invoice audit and approval functions by checking invoice details such as amounts, unit price, terms, tax, freight, etc. against the purchase order. Data entry effort is minimal, because invoice details are built from the purchase order and displayed on-line. Accounts payable clerks have to deal only with the exceptions, resulting in maximum efficiency with full control. The NCAS system uses a PC-based, laser printing process to support the creation of vendor payments. The laser check printing process has strong internal controls, including password protection access to the check printing software, the use of security chips in the printers themselves, as well as the use of blank check stock (vs. pre-printed check forms). Agencies print checks locally, using a nightly check file that is downloaded from the NCAS mainframe system.

The Inventory integration with the Purchasing system is designed to address warehouse replenishment needs. Information about stock items and requisitions for replenishment are passed from Inventory to Purchasing, and purchase orders and receipts pass from Purchasing to Inventory. The following information is shared between the two systems: items, requisitions, purchase orders, and receipts.

Requisitions are created to replenish warehouse inventory. They can be generated either automatically in batch by the system, or created manually by the inventory replenishment planner. Once approved, these requisitions automatically pass to Purchasing to be converted into purchase orders. When goods are received in the Purchasing function, the quantity is passed to Inventory to reduce the on-order quantity and increase the on-hand quantity. If goods undergo inspection in the Purchasing function, the active on-hand quantity is not increased in the Inventory until the goods have passed inspection.

The Materials Management systems maintain accounting integrity through integration with the General Ledger. Distribution entries from purchase orders, Accounts Payable and Inventory issues and replenishments are validated directly against the General Ledger. Offsetting cash, assets accounts, and encumbrances are automated through the accounting rules or system policies to ensure accounting accuracy.

The integration of the Materials Management functions with the budgetary control function provides the funds-checking capability required for the NCAS. All Purchasing, Accounts Payable, and Inventory transactions (commitments, encumbrances, inventory consumption and replenishment, and expenditures) are checked real-time to the available funds amount calculated through budgetary control functions. Real-time funds checking ensures expenditures are kept within the authorized budget and provides advanced knowledge of the budgetary status for spending decisions.

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Purchasing

The Purchasing function is a real-time, decision support application designed to help manage the entire procurement cycle. This cycle includes requesting, competitive bidding, buying, receiving, and inspecting. Purchasing agents' day-to-day decision-making is fully supported with tools and information on-line to manage the supplier base and service the purchasing function for the State in a timely and efficient manner. Figures 6 and 7 display the participants and tasks in the Purchasing or Competitive Sourcing and Vendor Selection processes, respectively. Purchasing Financial Functions

The State's purchasing policies and strategies are the basis for the system and are incorporated into a policy hierarchy. The policy hierarchy consists of rules that define how to handle purchasing functions within the government environment. The most general purchasing policies represent the highest level of the hierarchy, and each successive level below the general policy defines further levels of detail to the general policy.

As requisitions and purchase orders are processed, the policy hierarchy ensures that the majority of the purchasing activity is handled automatically and within the required purchasing guidelines. If a particular situation does not fit the general rules, a purchaser may change the hierarchy default to fit the situation; however, the system tracks in detail the full procurement process from requisition to payment.

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Overview of Current Purchasing Process

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The Purchasing function provides: Full integration with Accounts Payable, Inventory, Budgetary Control, and

General Ledger; Real-time encumbering of funds and confirmation of funds availability; A centrally-controlled item file that ensures a consistent statewide purchasing

history database; Common policy files for Purchasing and Accounts Payable; A statewide central vendor file that is shared by both Purchasing and Accounts

Payable; Funds checking at each decision point (requisition, purchase order, and Accounts

Payable); Buyer tools (on-line buyer split requisition worksheet);

Purchasing Reporting Functions Reporting within the Purchasing function supports:

Daily purchasing decisions through buyer action reports and buyer exception reports, and

Central management requirements for the Division of Purchase and Contract (P&C) HUB reporting and recycled goods reporting.

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QUALITY CONTROL DEPARTMENT

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QUALITY CONTROL

Quality control can be broadly defined as the day to day control of quality within the company, a department staffed with scientists & technicians responsible for the acceptance or rejection of incoming raw materials & packing components for the myriad of in-process tests & inspection to assure that systems are being controlled & monitored & finally for the approval or rejection of completed dosage forms. OBJECTIVE:

Evaluation of raw material In-process Testing

Finished Product Testing

Packing Material Testing

Microbial Test

SYSTEMS ADOPTED IN QUALITY MAINTENANCE:

All steps in production & packing are initiated only after the approval of the Q.A department

Every raw material, which enters the company, is tested foe purity. In other words 100% sampling is effected. This ensures that on low quality material enter the production set up.

In=process quality control Pharmacoepia limits.

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IN-PROCESS QUALITY CONTROL TESTS: TEST FOR RAW MATERIALS: Identification, Loss on drying, Heavy metals,

Sulphated ash & Assay. TEST FOR GRANULES: Bulk density, Moisture content & Assay. TEST FOR TABLETS: Weight variation, Disintegration time, Dissolution,

Friability & Assay. UNOFFICIAL TESTS: Hardness & Thickness.

ORGANIZATION CHART OF QUALITY CONTROL: Deputy General Manager Manager 2 Executive Officers 3 Officers

4 Chemists

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INSTRUMENTS USED IN QUALITY CONTROL DEPARTMENT

SL. No.

INSTRUMENT MODEL No. MANUFACTURER

1. Sonicator 300w DUEX Instruments 2. Automatic Titrator AT-38 Spectra Lab 3. Weighing Blances-2 AE 160 Mettler 4. Tablet Dissolution Test Apparatus DA-6D V Scientific 5. Digital pH meter PHAN Lab India pH

analyzer 6. Karl Fisher Apparatus AUTO-1 Globe Trotters Pvt.

Ltd. 7. Tapped Density Tester E.T-1020 Electrolab 8. Melting Point Apparatus ALM 310 Analink 9. Digital Conductivity Meter CIN-180 Elico Pvt. Ltd 10. Tablet friability Test Apparatus ALM 310 Veego Pvt. Ltd 11. Tablet hardness tester VDT Ketan 12. Tablet Disintegration Test apparatus VID-3 Veego Pvt. Ltd 13. Kompakt U.V Cabinet ---- Kompakt Pvt. Ltd 14. Antibiotic Zone Reader ---- Tab-Machines 15. Microscope ---- Labo Pvt. Ltd 16. Gradvel Laminar Flow 1103 Klenzaids 17. Drying Oven ---- Shivani Scientific

Industry (p) Ltd 18. Heating Mantle-3 UMA 59 Subhadra scientific

& Surgicals 19. Laboratory Oven for Drying ---- ACE Techno 20. Research Centrifuge TC 4100d Eltec Pvt. Ltd 21. U.V Spectrophotometer U.V1700 Shimadzu 22. Polarimeter 341 Parkin Elmer 23. F.T.I.R RX 1 FT-IT Parkin Elmer 24. Gas chromatograph OMEGA VIR Netel

Chromatographs 25. Potassium Bromide Press ---- Spectra Lab 26. H.P.L.C 875

U.V/VIS Detector & 880 PU Pump

Jasco

27. H.P.L.C 1100 Agilents

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QUALITY ASSURANCE DEPARTMENT

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QUALITY ASSURANCE Quality assurance may be defined as the responsibility of an organization to determine the systems-facilities that system-facilities & written procedures are both adequate & followed in order to assure that products are controlled & will meet the final dosage forms, all the applicable specifications. Quality assurance naturally then becomes an over site function, often auditing to determine that procedures & systems are suitable & if not, to recommend the required changes.

ORGANIZATION CHART OF Q.A

General Manager

Officers

Supervisor

Chemist

Quality assurance involves the activity of providing evidence, much needed to establish confidence among all those concerned, that the quality function being followed taken care of. Quality assurance provides protection against quality related problems. The responsibility of Q.A department is to control & assure the right quality of raw materials, packing materials & the finished products is maintained all along.

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INPROCESS INSPECTION

Objective In the concept of Quality Assurance, quality has to be built in throughout the process & not to be Checked /Controlled at final stage of Process i.e. finished product. In the process of building up of the quality, in-process inspection had major role. The in-process inspections serve to have checks at different stage of the manufacturing process, which ultimately controls the quality of the product. Responsibility : Quality Assurance Inspector

Chemist/Officer Quality Assurance is responsible to perform the activity as per procedure. They are directly reporting to Q.A.Manager Head of Quality Assurance is responsible for effective implementation and training of procedure.

Procedure

The persons are provided with check points for various operations & required to observed the deviations from the specified operational norms & are required to immediately report such deviations to the immediate person responsible for the operations & subsequently to Q.A Head. In case the person is doubtful about his judgment, he is required to stop the process as an immediate preventive action & then consult with senior for guidance in the matter. But in any case no operation, with any type of deviation is allowed to continue unless the doubt/deviation is sorted out

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Check point:- General

At the time of starting of the operation, check for total removal of unwanted material form the area. In case of other material is required to be stored in the area it should have been well segregated & labeled.

Check the area for cleanliness & required environment conditions.

Check that the operation is being carried out by an experienced & authorized operator.

Check that all personnel are wearing the required uniforms, nose masks, hand gloves etc.

Check that all container stored in the area are labeled with full details viz. Product, Batch No. Mfg., Exp. Date, Stage of operation.

Check that at a time, in a specified area & with the specified set of equipment, only one batch processed, there is no spill over of the batches & batch identity is maintained.

In case of any observed deviation ask the operator to discontinue the operation as an immediate preventive measure & report the deviation to the person in-charge of operation as well as to the Quality Assurance Head.

Physical parameters of in-process products are to be checked at the start of the batch and at random during the processing of the batch to verify that all parameters are within the prescribed limits .

Maintain the records of all the observations.

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FINANCE DEPARTMENT

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ACCOUNTING Costing :

The department in question has an enormous impact on the overall performance of any industry. The effectiveness or ineffectiveness of the costing department is quite clear or obvious at the slightest glance on the performance or result of the industry. Costing plays a major role as far as the yield of the industry goes. It plays a buffer role in between the management and the various operation departments.

Costing department in industry is supposed to be of the most efficient and result

oriented department and is directly responsible for determining the margin of profit. Costing department carries out various jobs such as, Determining the efficiency of the operations on which the incentive scheme is to

be formulated. Preparing the daily production report, monthly production report, monthly

performance report and so on. Record of the damages bottles which could be taken into A/C while preparing the

yearly A/C.

The most important function of the costing department is the provision of the material requirement for various department to the stores.

Costing department has also taken up the job of evaluating the efficiency of every single operation. Time study is done operationwise. For each operation with all the necessary time for getting the material. Costing department also records the receipts, issue of the costly or bulk requirement raw materials. The costing department has its own record for opening balance, issues during the month & receipts during the month. A physical inventory of stock is carried out.

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The costing department records all the issues of raw material. A comparison of actual issues as against budgeted or estimated quantity is made. Variances are found out and necessary action are taken such as : The correction in cost cards is made this exercise is carried out at every month

end and various statement prepared. Costing department also maintain a record for wastage, destroyed, samples given

as gift which helps in preparing the final A/C.

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MARKETING DEPARTMENT

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“The soul of the mktg. is to deliver a higher std. Of quality”

Marketing Department Involves Following Aspects :

1. Customer Demand & Sale Forecasting 2. Marketing Research & Information 3. Marketing Strategy / Planning 4. Advertising 5. Managing distribution channel 6. International Markets

Company Demand

Demand Market

Market (Industry demand) Company demand Market Potential Market Forecast Company Sale Company Sale

Potential Forecast

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Company Sales Forecast It is estimated sales turnover under a defined marketing program. The sales forecast is the planned level of sales based upon a given marketing strategy.

Sales Forecast Procedure

Economic Forecast – Level & Trends

Industry Activity & Forecast

Company Demand Forecast

Sale Demand Forecast

Sale Forecast

Based on what people say Based on what people do

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Various marketing strategies and steps are followed by marketing dept of Concept Pharmaceutical Ltd. This organization has a strong marketing unit with the help of this organization made a strong image in domestic as well as foreign market . Following is the plan & steps of company to be followed in marketing field. How to write a Marketing Plan

A marketing plan is a written document that details the actions necessary to achieve one or more marketing objectives. It can be for a product or service, a brand, or a product line. It can cover one year (referred to as an annual marketing plan), or cover up to 5 (sometimes referred to as five) years.

A marketing plan may be part of an overall business plan. Solid marketing strategy is the foundation of a well-written marketing plan. While a marketing plan contains a list of actions, a marketing plan without a sound strategic foundation is of little use. The Marketing Plan is generally undertaken for one of the following reasons : Needed as part of the yearly planning process within the marketing functional

area. Needed for a specialized strategy to introduce something new, such as new

product planning, entering new markets, or trying a new strategy to fix an existing problem.

Is a component within an overall business plan, such as a new business proposal

to the financial community.

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The marketing planning process Corporate mission Corporate vision Objectives for non-profit-making organizations Marketing audit Analysis Marketing objectives Emergent strategy Marketing strategies Detailed plans and programmes

Content of the marketing plan 2.1 Small business 2.2 Medium-sized and large organizations

Measurement of Progress Performance analysis Sales analysis Market share analysis Expense analysis Financial Analysis Use of Marketing Plans

Budgets as Managerial Tools 5.1 Approaches to budgeting

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The marketing planning process

In most organizations, "strategic planning" is an annual process, typically covering just the year ahead. Occasionally, a few organizations may look at a practical plan which stretches three or more years ahead.

To be most effective, the plan has to be formalized, usually in written form, as a formal `marketing plan'. The essence of the process is that it moves from the general to the specific; from the overall objectives of the organization down to the individual action plan for a part of one marketing programme. It is also an iterative process, so that the draft output of each stage is checked to see what impact it has on the earlier stages - and is amended accordingly. Corporate mission

Behind the corporate objectives, which in themselves offer the main context for the marketing plan, will lie the 'corporate mission'; which in turn provides the context for these corporate objectives. This `corporate mission' can be thought of as a definition of what the organization is; of what it does: 'Our business is …'.

This definitions should not be too narrow, or it will constrict the development of the organization; a too rigorous concentration on the view that `We are in the business of making meat-scales', as IBM was during the early 1900s, might have limited its subsequent development into other areas. On the other hand, it should not be too wide or it will become meaningless; `We want to make a profit' is not too helpful in developing specific plans.

Abell suggested that the definition should cover three dimensions: 'customer groups' to be served, 'customer needs' to be served, and 'technologies' to be utilized.

Thus, the definition of IBM's `corporate mission' in the 1940s might well have

been: `We are in the business of handling accounting information [customer need] for the larger US organizations [customer group] by means of punched cards [technology].' Fortunately, as the name itself (International Business Machines) indicates, IBM already had a wider perspective (and its corporate mission was virtually defined by its name). Planning is the key element of the management function

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Corporate vision

Perhaps the most important factor in successful marketing is the `corporate vision'. Surprisingly, it is largely neglected by marketing textbooks; although not by the popular exponents of corporate strategy - indeed, it was perhaps the main theme of the book by Peters and Waterman, in the form of their `Superordinate Goals'.[2] Theodore Levitt said: "Nothing drives progress like the imagination. The idea precedes the deed.

If the organization in general, and its chief executive in particular, has a strong vision of where its future lies, then there is a good chance that the organization will achieve a strong position in its markets (and attain that future). This will be not least because its strategies will be consistent; and will be supported by its staff at all levels. In this context, all of IBM's marketing activities were underpinned by its philosophy of `customer service'; a vision originally promoted by the charismatic Watson dynasty.

Henry Mintzberg explained: "... in some cases, in addition to the mission there is

the `sense of mission', that is, a feeling that the group has banded together to create something new and exciting. This is common in new organizations".

What a worthwhile vision consists of is, however, usually open to debate; hence

the reason why such visions tend to be associated with strong, charismatic leaders. But the vision must be relevant. The message for the marketer is that, to be most effective, the marketing strategies must be converted into a powerful long-term vision; if such a vision does not already exist.

Objectives for non-profit-making organizations

In the case of non-profit organizations the objectives may be less than clear. Keith

Blois suggested five main reasons for the differences from `commercial' organizations:

Ambiguous Goals [more actors and groups of actors are involved] Lack of Agreement in Means-End Relationships [even where there is consensus

on the goal there may be disagreement on how to get there] Environmental Turbulence [non-profit organizations seem to be exposed more to

turbulence than commercial ones] Unmeasurable Outputs [unfortunately, by definition, non-profit organizations do

not have the classically convenient simplicity of `bottom-line profit'] The Effects of Management Intervention are Unknown [the lack of precision

caused by factors 1-4 is problem enough, but the `culture' seems to add further barriers to managing these organizations]

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Even so, Kotler and Andreasen suggested some possible objectives for such organizations: Surplus Maximization [equivalent to profit maximization] Revenue Maximization [as for profit-making organizations] Usage Maximization [maximizing the numbers of users and their usage] Usage Targeting [matching the capacity available] Full Cost Recovery [breaking even] Partial Cost Recovery [minimizing the subsidy] Budget Maximization [maximizing what is offered] Producer Satisfaction Maximization [satisfying the wants of staff]

Marketing audit

The first formal step in the marketing planning process is that of conducting the

marketing audit. Ideally, at the time of producing the marketing plan, this should only involve bringing together the source material which has already been collected throughout the year - as part of the normal work of the marketing department.

The emphasis at this stage is on obtaining a complete and accurate picture. In a

single organization, however, it is likely that only a few aspects will be sufficiently important to have any significant impact on the marketing plan; but all may need to be reviewed to determine just which 'are' the few.

In this context some factors related to the customer, which should be included in

the material collected for the audit, may be: Who are the customers? What are their key characteristics? What differentiates them from other members of the population? What are their needs and wants? What do they expect the `product' to do? What are their special requirements and perceptions? What do they think of the organization and its products or services? What are their attitudes? What are their buying intentions?

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A `traditional' - albeit product-based - format for a `brand reference book' (or, indeed, a `marketing facts book') was suggested by Godley more than three decades ago: Financial data --Facts for this section will come from management accounting, costing and finance sections. Product data --From production, research and development. Sales and distribution data - Sales, packaging, distribution sections. Advertising, sales promotion, merchandising data - Information from these departments. Market data and miscellany - From market research, who would in most cases act as a source for this information.

This sources of data, however, assume the resources of a very large organization. In most organizations they would be obtained from a much smaller set of people (and not a few of them would be generated by the marketing manager alone). It is apparent that a marketing audit can be a complex process, but the aim is simple: 'it is only to identify those existing (external and internal) factors which will have a significant impact on the future plans of the company'.

It is clear that the basic material to be input to the marketing audit should be comprehensive. Accordingly, the best approach is to accumulate this material continuously, as and when it becomes available; since this avoids the otherwise heavy workload involved in collecting it as part of the regular, typically annual, planning process itself - when time is usually at a premium. Even so, the first task of this `annual' process should be to check that the material held in the current `facts book' or `facts files' actually 'is' comprehensive and accurate, and can form a sound basis for the marketing audit itself.

The structure of the facts book will be designed to match the specific needs of the organization, but one simple format - suggested by Malcolm McDonald - may be applicable in many cases. This splits the material into three groups:

'Review of the marketing environment'. A study of the organization's markets, customers, competitors and the overall economic, political, cultural and technical environment; covering developing trends, as well as the current situation.

'Review of the detailed marketing activity'. A study of the company's marketing

mix; in terms of the 4 Ps - product, price, promotion and place.

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'Review of the marketing system'. A study of the marketing organization, marketing research systems and the current marketing objectives and strategies.

The last of these is too frequently ignored. The marketing system itself needs to be regularly questioned, because the validity of the whole marketing plan is reliant upon the accuracy of the input from this system, and `garbage in, garbage out' applies with a vengeance. Analysis

The analysis of this material will, no doubt, require significant effort. In the first

instance it is a matter of selection, of sorting the wheat from the chaff. What is important, and will need to be taken into account in the marketing plan that will eventually emerge from the overall process, will be different for each product or service in each situation. One of the most important skills to be learned in marketing is that of being able to concentrate on just what is important.

It is important to say not just what happened but why. The process of marketing

planning encompasses all of the marketing skills. However, a number of these may be particularly relevant at this stage:

'Positioning'. The starting point of the marketing plan must be the consumer. It is

a matter of definition that his or her needs should drive the whole marketing process. The techniques of positioning and segmentation therefore usually offer the best starting point for what has to be achieved by the whole planning process.

'Portfolio planning'. In addition, the coordinated planning of the individual

products and services can contribute towards the balanced portfolio. '80:20 rule'. To achieve the maximum impact, the marketing plan must be clear,

concise and simple. It needs to concentrate on the 20 per cent of products or services, and on the 20 per cent of customers, which will account for 80 per cent of the volume and 80 per cent of the `profit'.

'4 Ps': Product, Place, Price and Promotion. The 4 Ps can sometimes divert

attention from the customer, but the framework they offer can be very useful in building the action plans.

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Marketing objectives

It is only at this stage (of deciding the marketing objectives) that the active part of the marketing planning process begins'.

This next stage in marketing planning is indeed the key to the whole marketing process. The marketing objectives state just where the company intends to be; at some specific time in the future. James Quinn succinctly defined objectives in general as: "Goals (or objectives) state 'what' is to be achieved and 'when' results are to be accomplished, but they do not state 'how' the results are to be achieved".

They typically relate to what products (or services) will be where in what markets

(and must be realistically based on customer behaviour in those markets). They are essentially about the match between those 'products' and 'markets'. Objectives for pricing, distribution, advertising and so on are at a lower level, and should not be confused with marketing objectives. They are part of the marketing strategy needed to achieve marketing objectives.

To be most effective, objectives should be capable of measurement and therefore

'quantifiable'. This measurement may be in terms of sales volume, money value, market share, percentage penetration of distribution outlets and so on. An example of such a measurable marketing objective might be `to enter the market with product Y and capture 10 per cent of the market by value within one year'. As it is quantified it can, within limits, be unequivocally monitored; and corrective action taken as necessary.

The marketing objectives must usually be based, above all, on the organization's

financial objectives; converting these financial measurements into the related marketing measurements.

In marketing, objectives are often built using the SMART acronym.

It is conventionally assumed that marketing objectives will be designed to maximize volume or profit (or to optimize the utilization of resources in the non-profit sector), by creating demand or rejuvenating existing demand, say; although the various sub-objectives may indicate many different routes to achieving such optimization.

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However, as Kotler suggested (in the earlier edition of his book), there may be a number of other objectives:

Synchromarketing

Demarketing

Counter-marketing

Synchromarketing - The aim may be to `redistribute' existing sales (which are already at optimum levels) so that they occur at times, or in places, which the supplier prefers. Thus, for example, organizations which have highly seasonal sales (which make inefficient use of resources) may want to increase non-seasonal sales. Walls achieved this by balancing its summer sales of ice-cream with pies and sausages, demand for which peaks in winter. The suppliers of central-heating oil offer special deals for those customers willing to restock their tanks in summer. Demarketing' - Demand may sometimes exceed supply. In these circumstances the emphasis will be on rationing scarce supplies. Occasionally the supplier, rather than bring on-stream expensive new plant, may seek to persuade customers to buy less (or be less dissatisfied with the scarcity). Some suppliers of electrical energy (electricity generators in Europe and the USA) have heavily advertised energy conservation measures to achieve this end (otherwise, the cost of meeting the peak winter loads would be very high - and unprofitable). Counter-marketing - In what is usually a public-sector activity (but is occasionally undertaken by the private sector, where some uses of a product are damaging the corporate image), there may be an objective of stopping consumption completely. The anti-tobacco and anti-drug campaigns are the most obvious examples; but McDonald's campaigns to stop its customers dropping litter, or the brewers' campaigns to stop drinking and driving, fall into this category. Emergent strategy

In this case, the intended strategy, decided upon traditionally or incrementally, is

overtaken by events in two main ways. One, which will probably be recognized by the organization, is that of unrealized strategy; where it proves impossible to implement the chosen strategy in practice.

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Less obvious is the emergent strategy which is decided by events in the external environment; and, thus, forced upon the organization. This may not necessarily be recognized, in its totality, by the organization - since many of its implications may be hidden. As markets become more complex, however, such emergent strategies are becoming more common.

Many organizations see both these processes in terms of failure - they have been

forced, usually by unpredictable events, to abandon their own strategy. There is, accordingly, a tendency for these unwelcome facts to be ignored until they are so obvious that they cannot be avoided. This is a major error. Such deviations must be recognised (probably through one or other form of environmental analysis coupled with networking) as soon as possible- so that the organization can react in good time.

A much more powerful approach is, though, to be proactive; so seize upon these

deviations as the basis for future developments. What needs to be recognized is that emergent strategies are the most powerful of all. They must, by definition, be directly derived from the needs of the market - where even successful deliberate strategies may not ideally match market needs but may achieve their targets by sheer force (especially where conviction marketing lies behind them). Emergent strategies are, thus, likely to be vigorous ones.

There are two main approaches to capitalizing on such emergent strategies. The

first of these, favored in the West, is the umbrella strategy. This is a form of very positive delegation, in that the overall strategies, the umbrella, are very general in nature - and allow the lower level managers, who are closest to the external environment, the freedom to react to these changes.

A much more direct, and hence even more powerful, approach is that favored by

the Japanese corporations. They integrate emergent strategies with their own. Indeed it is arguable that, in terms of marketing, to a large extent they use emergent strategies instead of their own deliberate strategies. This is evidenced as much by an attitude of mind as by any other feature. They deliberately go out to look for symptoms of such emergent trends which can be detected in the performance of their own products. More than that, though, they often deliberately launch a range of products rather than a single one to see which is most successful. It is almost as if they deliberately seek out the emergent strategies by offering the best environment for them to develop - the very reverse of the Western approach which seeks to avoid them. The Japanese then go on to build on these emergent strategies with a number of very effective tools - most of which are designed to overcome the major problem which accompanies emergent strategies, that they emerge on the scene much later than deliberate ones (and are likely to be visible to all the competitors at the same time) so that time is the essence.

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Thus, time management techniques (including parallel development along with flexible manufacturing and JIT) which have been developed by the Japanese offer them a significant competitive advantage in handling such emergent strategies. Marketing strategies

There are numerous definitions of what strategy is, but again James Quinn gave a

succinct general definition: "A strategy is a 'pattern' or 'plan' that 'integrates' an organization's 'major' goals, policies and action sequences into a 'cohesive' whole"[7] He went on to explain his view of the role of `policies', with which strategy is most often confused: "Policies are rules or guidelines that express the 'limits' within which action should occur.

Simplifying somewhat, marketing strategies can be seen as the means, or `game plan', by which marketing objectives will be achieved and, in the framework that we have chosen to use, are generally concerned with the 4 Ps. Examples are:

PRODUCT Developing new products, repositioning or relaunching existing ones and

scrapping old ones Adding new features and benefits Balancing product portfolios Changing the design or packaging

PRICE Setting the price to skim or to penetrate Pricing for different market segments Deciding how to meet competitive pricing

PROMOTION Specifying the advertising platform and media Deciding the public relations brief Organizing the salesforce to cover new products and services or markets

PLACE Choosing the channels Deciding levels of customer service

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In principle, these strategies describe how the objectives will be achieved. The 4 Ps are a useful framework for deciding how the company's resources will be manipulated (strategically) to achieve the objectives. It should be noted, however, that they are not the only framework, and may divert attention from the real issues. The focus of the strategies must be the objectives to be achieved - not the process of planning itself. Only if it fits the needs of these objectives should you choose, as we have done, to use the framework of the 4 Ps.

The strategy statement can take the form of a purely verbal description of the

strategic options which have been chosen. Alternatively, and perhaps more positively, it might include a structured list of the major options chosen.

One aspect of strategy which is often overlooked is that of 'timing'. Exactly when

it is the best time for each element of the strategy to be implemented is often critical. Taking the right action at the wrong time can sometimes be almost as bad as taking the wrong action at the right time. Timing is, therefore, an essential part of any plan; and should normally appear as a schedule of planned activities.

Having completed this crucial stage of the planning process, you will need to re-

check the feasibility of your objectives and strategies in terms of the market share, sales, costs, profits and so on which these demand in practice. As in the rest of the marketing discipline, you will need to employ judgement, experience, market research or anything else which helps you to look at your conclusions from all possible angles. Detailed plans and programmes

At this stage, you will need to develop your overall marketing strategies into detailed plans and programmes. Although these detailed plans may cover each of the 4 Ps, the focus will vary, depending upon your organization's specific strategies. A product-oriented company will focus its plans for the 4 Ps around each of its products. A market or geographically oriented company will concentrate on each market or geographical area. Each will base its plans upon the detailed needs of its customers, and on the strategies chosen to satisfy these needs.

Again, the most important element is, indeed, that of the detailed plans; which

spell out exactly what programmes and individual activities will take place over the period of the plan (usually over the next year). Without these specified - and preferably quantified - activities the plan cannot be monitored, even in terms of success in meeting its objectives.

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It is these programmes and activities which will then constitute the `marketing' of the organization over the period. As a result, these detailed marketing programmes are the most important, practical outcome of the whole planning process. These plans should therefore be:

Clear - They should be an unambiguous statement of 'exactly' what is to be done. Quantified - The predicted outcome of each activity should be, as far as possible,

quantified; so that its performance can be monitored. Focused - The temptation to proliferate activities beyond the numbers which can

be realistically controlled should be avoided. The 80:20 Rule applies in this context too.

Realistic - They should be achievable.

Agreed - Those who are to implement them should be committed to them, and

agree that they are achievable.

The resulting plans should become a working document which will guide the campaigns taking place throughout the organization over the period of the plan. If the marketing plan is to work, every exception to it (throughout the year) must be questioned; and the lessons learned, to be incorporated in the next year's plan.

Content of the marketing plan Small business A marketing plan for a small U.S. business typically includes Demographics of customers Description of competitors, including the level of demand for the product or

service and the strengths and weaknesses of competitors Description of the product or service, including special features Marketing budget, including the advertising and promotional plan Description of the business location, including advantages and disadvantages for

marketing Pricing strategy Market Segmentation

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Medium-sized and large organizations The main contents of a marketing plan are: Executive Summary Situational Analysis Opportunities / Issue Analysis - SWOT Analysis Objectives Strategy Action Programme (the operational marketing plan itself for the period under

review) Financial Forecast Controls

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IN DETAIL, A COMPLETE MARKETING PLAN TYPICALLY INCLUDES:

Title page

Executive Summary

Current Situation - Macroenvironment

Economy Legal Government Technology Ecological Sociocultural Supply chain

Current Situation - Market Analysis

Market definition Market size Market segmnetation Industry structure and strategic groupings Porter 5 forces analysis Competition and market share Competitors’ strengths and weaknesses Market trends

Current Situation - Consumer Analysis

Nature of the buying decision Participants Demorgraphics Psychographics Buyer motivation and expectations Loyalty segments

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Current Situation - Internal

Company resources

o Financial o People o Time o Skills

Objectives

o Mission statement and vision statement o Corporate objectives o Financial objective o Marketing objectives o Long term objectives o Description of the basic business philosophy

Corporate Culture

Summary of Situation Analysis

External threats External opportunities Internal strengths Internal weaknesses Critical success factors in the industry Our sustainable competitive advantage

Marketing research

Information requirements Research methodology Research results

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Marketing Strategy - Product

Product mix Product strengths and weaknesses

o Perceptual mapping

Product life cycle management and new product development Brand name, brand image, and brand equity The augmented product Product portfolio analysis o B.C.G. Analysis o Contribution margin analysis o G.E. Multi Factoral analysis o Quality Function Deployment

Marketing Strategy - segmented marketing actions and market share objectives

By product, By customer segment, By geographical market, By distribution channel.

Marketing Strategy - Price

Pricing objectives Pricing method (eg.: cost plus, demand based, or competitor indexing) Pricing strategy (eg.: skimming, or penetration) Discounts and allowances Price elasticity and customer sensitivity Price zoning Break even analysis at various prices

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Marketing Strategy - promotion

Promotional goals Promotional mix Advertising reach, frequency, flights, theme, and media Sales force requirements, techniques, and management Sales promotion Publicity and public relations Electronic promotion (eg.: web, or telephone) Word of mouth marketing (buzz) Viral marketing

Marketing Strategy - Distribution

Geographical coverage Distribution channels Physical distribution and logistics Electronic distribution

Implementation

Personnel requirements o Assign responsibilities o Give incentives o Training on selling methods Financial requirements Management information systems requirements Month-by-month agenda o pert or critical path analysis

monitoring results and benchmarks adjustment mechanism contingencies (What if's)

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Financial Summary

Assumptions Pro-forma monthly income statement Contribution margin analysis Breakeven analysis Monte carlo method Isi: internet strategic intelligence

Scenarios

Prediction of Future Scenarios Plan of Action for each Scenario

Appendix

Pictures and specifications of the new product Results from research already completed

Measurement of Progress The final stage of any marketing planning process is to establish targets (or standards) so that progress can be monitored. Accordingly, it is important to put both quantities and timescales into the marketing objectives (for example, to capture 20 per cent by value of the market within two years) and into the corresponding strategies. Changes in the environment mean that the forecasts often have to be changed. Along with these, the related plans may well also need to be changed. Continuous monitoring of performance, against predetermined targets, represents a most important aspect of this. However, perhaps even more important is the enforced discipline of a regular formal review. Again, as with forecasts, in many cases the best (most realistic) planning cycle will revolve around a quarterly review. Best of all, at least in terms of the quantifiable aspects of the plans, if not the wealth of backing detail, is probably a quarterly rolling review - planning one full year ahead each new quarter. Of course, this does absorb more planning resource; but it also ensures that the plans embody the latest information, and - with attention focused on them so regularly - forces both the plans and their implementation to be realistic. Plans only have validity if they are actually used to control the progress of a company: their success lies in their implementation, not in the writing'.

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Performance analysis The most important elements of marketing performance, which are normally tracked, are: Sales analysis Most organizations track their sales results; or, in non-profit organizations for example, the number of clients. The more sophisticated track them in terms of 'sales variance' - the deviation from the target figures - which allows a more immediate picture of deviations to become evident. `Micro- analysis', which is a nicely pseudo-scientific term for the normal management process of investigating detailed problems, then investigates the individual elements (individual products, sales territories, customers and so on) which are failing to meet targets. Market share analysis

Relatively few organizations, however, track market share. In some circumstances this may well be a much more important measure. Sales may still be increasing, in an expanding market, while share is actually decreasing - boding ill for future sales when the market eventually starts to drop. Where such market share is tracked, there may be a number of aspects which will be followed:

Overall market share Segment share - that in the specific, targeted segment Relative share -in relation to the market leaders

Expense analysis The key ratio to watch in this area is usually the `marketing expense to sales ratio'; although this may be broken down into other elements (advertising to sales, sales administration to sales, and so on). Financial Analysis The `bottom line' of marketing activities should at least in theory, be the net profit (for all except non-profit organizations, where the comparable emphasis may be on remaining within budgeted costs). There are a number of separate performance figures and key ratios which need to be tracked: Gross contribution<>net profit Gross profit<>return on investment Net contribution<>profit on sales

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There can be considerable benefit in comparing these figures with those achieved by other organizations (especially those in the same industry); using, for instance, the figures which can be obtained (in the UK) from `The Centre for Interfirm Comparison'. The most sophisticated use of this approach, however, is typically by those making use of PIMS (Profit Impact of Management Strategies), initiated by the General Electric Company and then developed by Harvard Business School, but now run by the Strategic Planning Institute. The above performance analyses concentrate on the quantitative measures which are directly related to short-term performance. But there are a number of indirect measures, essentially tracking customer attitudes, which can also indicate the organization's performance in terms of its longer-term marketing strengths and may accordingly be even more important indicators. Some useful measures are: market research - including customer panels (which are used to track changes

over time) lost business - the orders which were lost because, for example, the stock was not

available or the product did not meet the customer's exact requirements customer complaints - how many customers complain about the products or

services, or the organization itself, and about what. Use of Marketing Plans A formal, written marketing plan is essential; in that it provides an unambiguous reference point for activities throughout the planning period. However, perhaps the most important benefit of these plans is the planning process itself. This typically offers a unique opportunity, a forum, for `information-rich' and productively focused discussions between the various managers involved. The plan, together with the associated discussions, then provides an agreed context for their subsequent management activities, even for those not described in the plan itself. Budgets as Managerial Tools The classic quantification of a marketing plan appears in the form of budgets. Because these are so rigorously quantified, they are particularly important. They should, thus, represent an unequivocal projection of actions and expected results. What is more, they should be capable of being monitored accurately; and, indeed, performance against budget is the main (regular) management review process.

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The purpose of a marketing budget is, thus, to pull together all the revenues and costs involved in marketing into one comprehensive document. It is a managerial tool that balances what is needed to be spent against what can be afforded, and helps make choices about priorities. It is then used in monitoring performance in practice. The marketing budget is usually the most powerful tool by which you think through the relationship between desired results and available means. Its starting point should be the marketing strategies and plans, which have already been formulated in the marketing plan itself; although, in practice, the two will run in parallel and will interact. At the very least, the rigorous, highly quantified, budgets may cause a rethink of some of the more optimistic elements of the plans. Approaches to budgeting Many budgets are based on history. They are the equivalent of `time-series' forecasting. It is assumed that next year's budgets should follow some trend that is discernible over recent history. Other alternatives are based on a simple `percentage of sales' or on `what the competitors are doing'. However, there are many other alternatives - Ven: Affordable - This may be the most common approach to budgeting. Someone,

typically the managing director on behalf of the board, decides what is a `reasonable' promotional budget; what can be afforded. This figure is most often based on historical spending. This approach assumes that promotion is a cost; and sometimes is seen as an avoidable cost.

Percentage of revenue - This is a variation of `affordable', but at least it forges a

link with sales volume, in that the budget will be set at a certain percentage of revenue, and thus follows trends in sales. However, it does imply that promotion is a result of sales, rather than the other way round.

Competitive parity - In this case, the organization relates its budgets to what the

competitors are doing: for example, it matches their budgets, or beats them, or spends a proportion of what the brand leader is spending. On the other hand, it assumes that the competitors know best; in which case, the service or product can expect to be nothing more than a follower.

Zero-based budgeting - In essence, this approach takes the objectives, as set out in

the marketing plan, together with the resulting planned activities and then costs them out. Differences between marketing and business plans.

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Marketing Research & Information In Endurance there are three major components at the market information system.

1. Internal market information 2. Marketing Intelligence 3. The marketing research project

Marketing Information system

Internal Accounting Marketing Marketing Marketing System Intelligence Research Management System System Science Storage & Evaluation Evaluation Evaluation Recall on demand Editing & & Editing & Editing Dissemination Management Information Systems Department Computer related this department performs operations. E.R.P. BAAN Package is used.

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SWOT ANALYSIS

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SWOT Analysis

Strengths, Weaknesses, Opportunites and Threats (SWOT). SWOT analysis is a tool for auditing an organization and its environment. It is the first stage of planning and helps marketers to focus on key issues. SWOT stands for strengths, weaknesses, opportunities, and threats. Strengths and weaknesses are internal factors. Opportunities and threats are external factors. At the bottom of this page are FREE SWOT examples - so please read on. Strengths: attributes of the organization that are helpful to achieving the objective.

Weaknesses: attributes of the organization that are harmful to achieving the objective.

Opportunities: external conditions that are helpful to achieving the objective.

Threats: external conditions that are harmful to achieving the objective.

Strengths

Specialist marketing expertise. A new, innovative product and service. Location of your business. Quality processes and procedures. Price and schemes. Plant location and layout. Collabration with Lupin Pharmaceutical

Weakness

Lack of personnel expertise. Small turnover of company. Location of vedors are away from plant. Pamaged reputation. A weakening economy. Lack of integration between offline and online resources. Some departments not knowing what others are doing.

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Opportunities

A developing market such as the Internet. Mergers, joint ventures or strategic alliances. Moving into new market segments that offer improved profits. A new international market. A market vacated by an ineffective competitor in generic medicine. More space for growth.

Threats

A new competitor in your home market. Price wars with competitors. A competitor has a new, innovative product or service. Competitors have superior access to channels of distribution. Taxation is introduced on your product or service. Change in consumer attitude. An increase in unemployment.

Simple rules for successful SWOT analysis.

Be realistic about the strengths and weaknesses of your organization when conducting SWOT analysis.

SWOT analysis should distinguish between where your organization is today, and where it could be in the future.

SWOT should always be specific. Avoid grey areas. Always apply SWOT in relation to your competition i.e. better than or worse than

your competition. Keep your SWOT short and simple. Avoid complexity and over analysis SWOT is subjective.

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CONCLUSION

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CONCLUSION

At last coming to conclusion I would like to add ‘ Aims and Objectives’ came true during implant training.

The best thing to share about implant training is that whole implant environment

come in front of me and now further it is easy to breath comfortably in plant. Any companies efficiency based on chemistry of various departments such as

personnel, finance, marketing purchase etc. to go head with competency company have to manage this chemistry of departments. Each department of organization has it’s specified area of work. But to work in total co-ordination it is very much essential that every employee should have general idea about the objectives and functions of each department. It also makes the communication and work pattern much more easier and smoother. All these are only possible through proper induction and implant training which we have experienced.

About Concept Pharmaceutical Ltd. Is well going on up warding path.

‘Ofloxacin’, ‘Becef’, ‘Concitone’, ‘Disogel syrup’ are some brands having huge market and company’s motivated human resource taking effort to grab each and every opportunity. Company’s strengths dominate the weaknesses and trying to achieve more. As concern to future strategy of company, it ensures many new brands of company will touch the new milestones.

But with the positive side company have to see also another side of coin, as some

weaknesses which might be dangerous in long run if not given proper attention. Competitors like Ranabaxy, Wockhardt, Cipla, FDC etc are stronger and well positioned in market segment. To overcome them in market company should have apply new policies and strategies.

Also company has well scope in international market. If company retain same

position, it ha bright future. If company invest amount in purchasing advance machinery it well help to improve quality as well boost companies’ image in market.