CHAPTER 1

AN

INTRODUCTION

AND LAYOUT

1

INTRODUCTION

JYOTI REMEDIES is a research & development driven, pharmaceutical manufacturing

group of companies .Our manufacturing location in India- is at Saproon, the industrial

Hub of Himachal Pradesh State of India.

Our multidimensional Ethical product range includes:  Capsules, Tablets. We strictly

follow WHO GMP norms for manufacturing process for all our products. Our Contract

manufacturing of products provides great value to major marketing companies of India.

We are truly committed to alleviate human suffering in the most possible ethical manner.

JYOTI REMEDIES  commitment to serve the mankind predominantly with an objective

to provide top quality and cost effective products. Mr. Kuriakose initiated pharmaceutical

business activities in 1986 and started manufacturing process by setting up a full fledged

drug formulation unit in Kerala in the year 1993 Under-cited were the primary

objectives at the start of Jyoti Remedies

Consistency in maintaining high quality drugs

Constantly expanding products portfolio

One time product delivery

State of the art manufacturing facilities

Conforming to prevalent and demanding international standards

Today Jyoti Remedies commands a reputation of upcoming pharmaceutical thespian in

the pharma world with 4 Divisions.The group of concerns are:

Ce-Biotec (P) Ltd.

Ce-Chem Formulations

Jupiter Drugs

2

3

4

CHAPTER 2

ORGANISATION

5

MANAGING BODY

Board of Directors:

Managing Director (M.D.) : Mr. C.P. Kuriakose & Mr. Sudhir Sharma

Others:

Production Incharge : Mr. Lal Singh

Q.C. Incharge : Mr. Bhaskar Patel

Store Incharge : Mr. Manoj Sharma

Maintenance Incharge : Mr. Azad Ali

Marketing Incharge : Mr. Ajay Sharma

Computer Operator : Miss Kalpna

Corporate Office : Ce-Biotec (P) Ltd.

Ce Pe Towers, tana, P.B. No.23

Irinjalakuda, Trissus 680101

Kerala, India Tel. No. 0480-2825605

Factory at : Jyoti Remedies (P) Ltd.

Vill. Kailer, Subhathu road

P.O. saproon, Solan India 173211

Tel. No. 0192-228378, 09805559011

6

GMP FOR PREMISES AND MATERIALSTABLE 2 SPECIFIC REQUIREMENTS OF PLANT & EQUIPMENT:

S.no

Section

Area (minimum)

For basic installation For ancillary area

1: Tablets 60 Sq. m (Uncoated)

30 Sq. m (Coated)

20 Sq. m

10 Sq. m

2: Capsules 25 Sq. m 10 Sq. m

3: Repacking of drugs & pharmaceuticals

35 Sq. m

1 General requirements:-

1.1) Location and surroundings: Jyoti Remedies Pvt. Ltd. is situated in Vill. Kailer,

Subhathu road P.O. saproon, SolanThe location of this factory is such that it

avoids risk of contamination from external environment including open sewage,

drain, public lavatory or any factory which produces disagreeable or obnoxious

odour, fumes, and smoke, chemical or biological emission.

1.2) Building and premises: Factory’s building conformed to the conditions laid down

in the factories act, 1948. The premises used for manufacturing, processing,

warehousing, packaging labeling and testing purposes is compatible with other

drug manufacturing operation. It has adequate working area which allow orderly

and logical placement of equipment, materials and movement of personnel so as

to avoid the risk of mix up, contamination and cross contamination.

2 Ware housing area:

It has adequate area with proper racks, bins and platforms for the storage and

warehousing of all materials and products, machine and equipment parts etc.

Adequate fire protection measures are also present.

7

3 Production area:

In Jyoti Remedies, this area is designed to allow the production preferably.

Working and in process space is adequate to permit orderly and logical

positioning of equipment and materials and movement of personnel to avoid cross

contamination.

4 Ancillary area:

Rest and refreshment rooms are separate from other areas and do not lead directly

to the manufacturing and storage area. Separate toilets for males and females are

provided.

5 Personnel:

The manufacturing is conducted under the direct supervision of Mr Lal Singh.

(Manufacturing Incharge). The company has very well qualified and competent

technical staff.

6 Health, clothing and sanitation of workers:

Prior to employment all personnel’s undergo medical examination. They wear

clean body covering. Smoking, eating, drinking, chewing or keeping plants, food,

drink and personnel medicines are not permitted in production laboratory storage

and other areas.

7 Precaution against mix-up and cross contamination:

Recalled or rejected material and other material that are not to be processed or

recovered are kept in segregated, enclosed areas.

8 Sanitation in manufacturing premises:

Manufacturing premises of Jyoti Remedies is cleaned and maintained in an

orderly manner. It is free from accumulated waste, dust, debris and other material.

9 Raw materials:

All raw materials are purchased from approved sources. There are adequate

separate areas for material under test, approved and rejected. All the containers of

raw materials are placed on the raised platforms, racks.

8

10 Equipment:

All the equipments are located designed, constructed, adapted and maintained to

suit the operation. Balances and other measuring equipments are calibrated and

checked on a periodical basis.

11 Labels and other printed materials:

The label carries all the prescribed detail about the product. All containers and

equipment bears appropriate label. Different colour coded label are used to

indicate the status of the product.

Example:

Under test Yellow

Passed Green

Rejected Red

12 Master formula record:

Jyoti Remedies has master formula records relating to all manufacturing

procedure for each product and batch size to be manufactured.

13 Batch processing records:

These records are based on the relevant parts of the currently approved master

formula.

9

JYOTI REMEDIES

Vill.-Kailer, Subhathu road P.O. saproon, Solan

MANUFACTURING RECORD

(As Per Schedule U & GMP)

Name of Product…………………..Master Formula Ref. …………………………

Size…………………..B.No……………….S.No…… ………………………………

Room Temp……………R.H………….Date Of Commencement……………………

INGREDIENTS Label Claim

C.R. No. Qty. Req. Qty. Used Stock Ledger

Kg. gm. Kg. gm.

Active Ingredients

FILLERS

Starch I.P.

Di Cal. Phos. I.P.

Lactose I.P.

Date of Mixing ……………… Duration……….Hrs. Total Wt =………………..

PASTE (Binders)

Starch

Gelatin

Sod. Benzoate

Colour

Date Of Granulation……………………….. Dried at =………………………………

Time Required…………………………… Wt. Of Dried Granules……………………

10

LUBRICANTS

Starch (Dried)

Talcum

Mag. Stearate

TOTAL Wt.=

Weight of Lubricated Granules =_______________________Kg

Added Lubricated Granules of previous

Batch No. =_______________________Kg

(wt. Per tablet______________mg)

Total wt. Of Lubricated Granules ready for

Compression = Kg

COMPRESSION:

Date of Compression_____________

Weight of One tab. Should be_______________mg

Punch size Diameter_____________ Width_______________ Length___________

Appearance____________________________ Surface________________________

Scored___________________________ Embossed__________________________

Hardness__________________Kg/cm2 Disintegration Time____________________

Friability_______________% Weight of 20 tablets______________gm

Average weight per tablet______________

Permissible limit of wt. Variation____________

Individual wt. Of 20 tablets in mgs.

11

PACKINGS

Packing Material Required:

PARTICULARS QTY. USED

DESTROYED TOTAL STOCK LEDGER

Boxes (Plastic)

Pouch

Labels

Strips Qty.

Cartoons

Catch Cover

Printed Particulars On Label Batch No._________________

Rate Strip (per 10 tabs) =_________________

Mfg. Date__________________ Exp. Date____________________

Date______________

No. of Box Qty. per Box Total Tablets

Samples: For Analysis :

12

For Quality Control Deptt. :

________________________

Total =

________________________

Percentage Yield

Date of Completion ____________________

Quality Control:

Sample Tested by______________________________________________________

Analytical Report No._____________________ Date__________________________

Result: Passes/Fails

Date of Release For Warehouse___________________________________________

_____________________________________________________________________

Quantity Released To Warehouse:

PACKING NO. OF BOXES STOCK LEDGER

Date Of Completion:___________________

Signature Assistant Mfg. Chemist Signature Analytical Chemist

Signature Mfg. Chemist In-charge_______________________

13

In-Process Quality Control :

Hardness of tablet________________Kg/cm2 Friability____________________

Disintegration Time_______________ Wt. Of 20 Tablets _______________gm.

Average Wt. Per Tablet_________________ Claim_______________________

Permissible Limit Of Wt._______________

Individual Wt. Of 20 Tablets in mgs.

Wt. Of 20 Tablets at intervals of 30 Minutes in gm.

1: 2: 3: 4:

5: 6: 7: 8:

9: 10: 11: 12:

13: 14: 15: 16:

17: 18: 19: 20:

21: 22: 23: 24:

25: 26: 27: 28:

29: 30: 31: 32:

Signature of Analytical Chemist

14

CHAPTER 3

TABLET SECTION

15

INTRODUCTION

Tablets are obtained by compression of uniform volumes of powders or granules by

applying high pressures and using punches and dies. The particles to be compressed

consists of one or more medicaments, with or without auxiliary substances such as

diluents, binders, disintegrating agents, lubricants, glidants and substances capable of

modifying the behavior of the medicaments in the digestive tract. Such substances must

be innocuous and therapeutically inert in the quantities present. It is possible to

manufacture tablets in a wide range of shape, size and weight which depends on the

amount of medicament and the mode of administration. but they are also available in

special shapes like round, oval, oblong, cylindrical, square, triangular etc.

Official tablets are defined as circular discs with either flat or convex faces. The tablets

provide an accurate, stable dose of drug with the necessary physical and chemical

properties for the requirement of duration and intensity of therapeutic action.

Defination of Tablet According To I P – 1996

Tablets are solid dosage form each containing a unit dose of one or more medicaments.

They are intended for oral administration.

Defination of Tablet According to USP – 23rd Edition:-

Tablets may be defined as the solid unit dosage form of medicament(s) with or without

suitable diluents and prepared either by molding or by compression.

Manufacturing of Tablet:-

There are different processes, which are involved in the manufacturing of tablet. These

are as follows:-

Weighing section

Granulation section

Drying section

Compression section

In Process Quality control

Coating section

Packaging section

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MIXING

In this process, the raw materials (Medicaments + fillers) are taken from raw material

store room and then weigh accurately as per master card in the balance room.

These raw materials are then sifted in accordance with a specific no. of sieves. The sieved

raw materials are then mixed uniformly by Ribbon Blender (Sigma mass mixer). This

blender has a capacity of 100 kg. It is made up of stainless steel covered at top according

to the GMP.

Preparation of Binder solution (Starch and Gelatin Paste):-

a) The hot gelatin solution of specified quantity was prepared using D.M. water.

b) Suitable coloring agents were dissolved in small quantity of water and then

incorporated in hot gelatin solution with stirring until it mixes uniformly.

c) Now prepare starch solution of specified quantity in cold water and then mixed

gradually in small amounts in hot gelatin solution with constant stirring.

After appropriate mixing of raw materials, the granulating agent binder solution

(starch &gelatin paste) is added to form a uniform wet mass for granulation. The uniform

wet mass is then sent to the granulating department.

NOTE :- The binder solution must be added in small parts with constant blending to

avoid formation of lumps.

PRECAUTIONS:-

a) Coloring agents were added in hot gelatin sol. prior to starch sol. to avoid the

problem of MOTTLING.

b) To prevent the formation of lumps, starch solution should always be made in cold

water.

c) Constant stirring is required after addition of starch solution to avoid sticking of it

with vessel.

17

TABLE NO. 1 – LIST OF BINDERS

S.N.

Name % Used Solvents

1. Gum Acacia 2-5 Water, alcohol water

2. Traga Canth 1-3 Water (mucilage)

3. Gelatin 1-4 Water

4. Sucrose 2-20 Water

5. Starch 1-4 Water (paste)

6. Sodium Alginate 3-5 Water

7. Ammonium calcium alginate

3-5 Water

8. Methyl cellulose 1-4 Water

9. Sodium carboxymethyl cellulose

1-4 Water

10. Ethy Cellulose 0.5-2 Water

12. Poly vinylpyr rolidone 2-5 Water alcohol, alcohol water

13. Magnesium aluminium silicate

3-5 Water

GRANULATION:-

There are three methods generally used for granule formation -

(a) Wet Granulation Method

(b) Dry Granulation Method

(c) Direct Compression Method

Granulating mass received from the mixing unit is granulated by using multi mill

(specific granule size sieve is used).

Granules are then dried in the tray dryer. The tray dryer has the capacity of 200 kg

material (44 trays). For specific medicaments and particular granule size, specific time

periods and temperature are required for proper drying.

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After production and drying of the granules, the granules are prepared for the

compression. For this various additives like glidants (starch, talc), disintegrating agent

(starch, cmc), lubricating agent (mag. Stearate) and antiadherent (talc, starch) are added in

specific conc. The prepared granules are then finally taken for the compression.

COMPRESSION

The granules received from the granulating section are compressed into the unit dosage

tablets by using single stoke multi punch tab. machine, has a good output.

TABLE NO.2 : - WATER SOLUBLE TABLET LUBRICANTS

S.N

.

Lubricant Suggested %

2. Sodium Chloride 5

3. Sodium Benzoate 5

4. Sodium Acetate 5

5. Sodium Oleate 5

6. Polyethylene Glycol 4000&6000 1-4

COATING SECTION

Application of coating to the tablet, which is an additional step in the manufacturing

process, increases the cost of product. The tablet is coated due to the following reasons-

i. To mask the taste, odor, or color of the tablet.

ii. To provide physical & chemical protection for the drug.

iii. To control the release of drug from the tablet.

iv. To protect drug from gastric environment.

Principle: - Tablet coating is the application of a coating composition to a moving bed of

tablets, with the concurrent use of a heated air to facilitate evaporation of the solvent. The

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distribution of the coating is accomplished by either perpendicular or vertical movement

of the tablet.

Tablet Coating Pan

The coating pan is designed by the following basic components-

Coating Pan Circular metal pan mounted somewhat angularly on the

stand.

Blower & Exhaust.

Coating Sprayer.

Controlling devices

Working

1. Switch on the exhaust system and hot air blower.

2. Coating solution is filled in the coating sprayer and tablets to be coated filled in the

coating pan.

3. Carry out coating operation as per the procedure.

4. After completing the coating remove the coated tablets from the pan into a poly bag.

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COLOURING AGENT

Tartazine Sunset yellow

Carmosine lake Iron oxide Red

Quinaline Yellow lake Erythrosine Lake

Iron Oxide Yellow Poneau- UR

Idacol Brillant blue FOF Supra

DISINTEGRANTS

Cross carmell sodium Starch 1800

Veegum granules

LUBRICANTS

Magnesium sterate Boricin

Stearic acid Talcum

Inwitor 900 glyceryl monosterate PEG

BINDERS

Acacia Gelatin

Primallose

DILUENTS

Floedac-100 (Lactose) Lactopress202

Dibasic calcium phosphate Vivapress (CaCO3)

FLAVOURING AGENT

Trusil peppermint special Orange flavor

Trusil pineapple special Chocolate flavor

PRESERVATIVES

Sodium benzoate Citric Acid

Sodium propyl paraben Sodium methyl paraben

Methyl Paraben

TABLE NO-3 LIST OF EXCIPIENTS

21

PACKAGING :-

The finished tablets received from compression section are packed into various types of

packaging. Packaging ensures the security and attractiveness of various tablet dosage

forms. Packaging of product is very important as it decides customer’s acceptability to a

great extent. Now-a-days, every company want to attract customers by any means to meet

competition and packaging is one of the best ways of attraction as it is also an art. In

JYOTI REMEDIES, packaging is done in different following ways:

Bulk packaging:

For bulk packaging of tablets, tablets are counted by a counting device. The hundred

tablets are counted once at a time. These counted tablets are packed into 100,500 and

1000 tablets poly pack and sealed with the plastic containers of specific size.

It is used rarely when drug supplied to a dispensing pharmacy. In this drug is packed in a

bulk quantity to reduce the cost and it is generally used for etc products.

Strip packaging:

A strip package is formed by feeding to webs of heat seal able flexible film through a

heated crimping roller. The product is dropped in to the pocket formed prior to forming

the final set of seal. A continuous strip of packets is formed. The strip of packets is cut to

the desired number of packets in the length. The strips formed are collected & usually

packed into folding cartons.

Blister packaging:

This type of packaging provides excellent environment protection, aesthetically pleasing

appeal and children resistance.

Blister packaging is formed by heat softening sheet of thermoplastic resin & vacuum

drawing the softened sheet of plastic in contoured mould. After cooling, the sheet is

released from the mould & proceeds for filling. The semi rigid blister previously formed

is filled with the product & lidded with heat seal able packing material. The lidding may

be push through or peel able type.

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PROGRAMS ADOPTED FOR OBSERVING GMP AND TO BUILD QUALITY IN

THE PRODUCT:

TABLE:- 4 SOME COMMON PROBLEMS IN TABLETS

1. WEIGHT FLUCTUATIONS REASON

REMEDY

(a) Unsuitable granule size Change the granule size, usually small granules are for smaller tablets.

(b)

Granule Shape Prepare or round granules as possible to avoid uneven air spaces.

(c) Powder Content The proportion of fine powder should be kept below 20% of granulate.

(d)

Volume Differential The filling volume in the die should be as near as possible to the loose volume density.

(e) Flow control Lubricants-choice and quantity may be changed to control the flow of granules usually 1-5% are sufficient.

(f) Electrostatic Charging This can be eliminated by spraying the granules with water in order to increase their conductivity so that the electricity is conducted to the surrounding machine part are earthed

(g) Humidity If the granulate is too wet re dry the granules

(h)

Mechanical Factor

(i) Excessive compression speed

(ii) Vibration in hopper

(iii) Faculty guiding at lower

Reduce Speed

Use vibration absorbing mounting of the hopper

Replace warn filling and closing cams

2. DOUBLE FEED Double Feed may occur when tablets adhere to the punches or if they are not properly ejected due to in correct setting of ejectors check the setting of enjectors.

3. CAPPING

(a) Insufficient Moisture Spray the granules with water or water glycerin mixture.

(b)

Excessive Moisture Redry the granules.

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(c) Insufficient or unsuitable binder In crease the binder or regranulate with a more suitable binder.

(d)

Excess air ingranulate Adjust the relative punch travels to compress in upper part of the die or use tapered dies.

(e) Excess powder content Sift out the fine powder or regranulate with different binders.

(f) Mechanical Factors

(i) Excessive pressure

(ii) Insufficient air escape

(iii) Tablet design & engraving

Reduce the compression speed.

Use tapered dies. Compression should take place in upper part of die. Apply precompresion before actual compression.

Change ratio between diameter diameter and thickness. Engraving grooves should be rounded. The ideal standard toper is 2/3 of compansion measurements.

4. CRACKING

(a) Excess moisture in granulate Redry the granules.

(b)

Unsuitable Lubricants Change the lubricants.

(c) Mechanical Factors

(i) Cam tolerance exceeded

(ii) Incorrect fitting of punches

Repair or replace the cam.

Recheck.

5. STICKING

(a) Excessive humidity Dry the granules and/or air condition the room.

(b)

Low melting point of Seperately granulate such ingradients.

(c) Insufficient cohesion individual ingredient

Slowly raise the compression pressure.

(d)

Excess powder Sift out excess powders

(e) Insufficient lubrication Increase or change the lubricant.

(f) Dies and punches dull Polish the dies and punches.

(g) Defective engraving design Use rounded edges.

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There are different tests that are used for INPROCESS QUALITY CONTROL of

tablet dosage form. These are as follows:

Weight Variation Test

METHOD: Weigh 20 tablets selected at random and calculate the average weight not

more than two of the individual weights deviate from the average weight by more than

the percentage shown in table below and none deviates by more than twice that

percentage.

TABLE:- 5 WEIGHT VARIATION STANDARD

Average weight of tablet Percent deviation

80 mg or less 10

More than 80 mg but less than 250 mg 7.5

250 mg or more 5

HARDNESS TEST

Hardness of tablet determines its tensile strength. It must be such that the tablet can

withstand the shock of handling, packaging and shipping. It is measured in terms of

load/pressure. It is evaluated by the hardness tester by keeping the tablet in a vertical

position and crushing it. Different types of hardness testers can be used like-

Monsanto hardness tester

Pfizer hardness tester

Strong-Cobb tester

Erweka tester

Schleuniger tester

Hardness of 4 kg./cm.sq. is considered to be a minimum requirement.

25

FIG.-1 HARDNESS TESTER MONSANTO TYPE

FRIABILITY TEST

This test is performed to evaluate the ability of a tablet to withstand abrasion,

friction and shock in packing, handling and transportation. The apparatus used to

determine friability is called FRIABILITY TEST APPARATUS (ROCHE

FRIABILATOR). Friability value should not be more than 0.8%.

Formula-

(Wt. of tablet before test- wt. of tablets after test) 100

Wt. of tablet before test

FIG.-2 TABLET FRIABILITY TEST APPARATUS

26

DISINTIGRATION TEST

Disintegration is defined as that state in which no residue of the tablet or capsule remains

on the screen of the apparatus or, if a residue remains. It consists of fragments of

insoluble coating of the tablets or of capsule shells or is a soft mass with no palpable core.

It is an important step which determines the disintegration time of tablet.

TABLE:- 6 DISINTEGRATION STANDARD IP 1996

DISSOLUTION

The rate of dissolution plays an important role in the mechanism of drug absorption. The

drug is not absorbed unless it comes in the form of a solution. This is an important test for

drugs having poor solubility. Generally, drugs that have solubility greater than 1 % do not

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TABLETS LIQUID at 37 ± 2`C

DISINTEGRATION

TIME

Uncoated Tablets Water 15 min.

Coated (Sugar/ Film) Water 60 min.

If any of tablet don’t disintegrate, replace water

with 0.1N HCl all 6 tablets must disintegrate

Enteric Coated 0.1N HCl

Should show no

disintegration for 2hrs.

Mixed Phosphate Buffer at pH=6.8 60 min.

Vaginal Tablets Water 30 min

Soluble & Dispersible

Tablets Water at 19-21`C 3 min

pose any problem but the drugs with lower solubility are primarily studied for dissolution

rate.

EQUIPMENTS USED IN TABLET SECTION

MIXING, GRANULATION & DRYING SECTION:

According to ‘Schedule M’ requirements.

TRAY DRYER:-

Mfg. By – Fabricated by industry itself.

Capacity – 200 kg. (44 trays)

Application - For drying

MULTIMILL:-

Mfg. By – Sehgal Industrial works, Delhi

Model : GMP S/S 304 Contact Parts

Principle - Impact & attrition, which reduces the clumps to

small & uniform size by milling & these are then

sieved or screened through sieve no. 8 or 10.

RPM : 750 to 3000 rpm.

Application - For granulation.

FIG. 3 MULTI MILL

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SOP :-

1. from last batch.

2. Start the machine either in forward or reverse depending on size reduction to

be carried out .

3. Charge production into the hopper.

4. Open slide value slowly let the product enter the chamber.

5. Regulate the input by adjustment of slide value.

6. Maximum uniform output can be obtained by maintaining a constant rate of

feeding.

Caution !!!

OVEN FEEDING MAY JAM THE ROTOR AND BEATERS AND CAN DAMAGE

MASS MIXER:-

Mfg. By – Sehgal Industrial works, Delhi

Capacity – 150 kg.

Application - Holds the material & brings mixing by means of

moving screws, paddles or blades.

FIG 4 - MASS MIXER

29

SOP :-

1. Load the material from the container into the bowl as per the sequence

specified in the individual product batch manufacturing record.

2. Close the lid. Lock the three locking clamps.

3. Put the main switch on.

4. Before the starting the operation of the mixer ensure that it is cleaned as per

work instruction.

5. Load the materials and close the lid.

6. Start the dry mixing and run the mixer for 15 minutes.

7. At the binder paste / binder solution by opening the observation lid.

8. Selection of the time depends on what is specified in the individual BMR.

9. Add additional water it required and do the further mixing.

DOUBLE CONE BLENDER :-

FIG. 5 DOUBLE CONE BLENDER

a) Two cones are joined to a small cylindrical section.

b) This overcomes slow horizontal movement of solids found in a cylindrical

mixer.

30

c) Due to conical shape good rolling action of the solids prevail.

COATING PAN

This pan is used for film and sugar coating of tablets.

Salient features:-

1. Coating pan is made of SS 304

2. Totally enclosed with M.S. cladding with standard gearbox, motor and hot air

blowing arrangement.

3. Designed with M.S. fabricated structure.

4. Mounted on dynamounts, this avoids foundation.

FIG.:-6 COATING PAN

5. Coating Machine has variable speed drive and hot air blowing system in built in the

machine.

II. COMPRESSION SECTION:

1) SINGLE STROKE DOUBLE PUNCH MACHINE:-

Mfg. By – Ahiman Engineers.

Capacity – Each machine is capable of compressing one

lakh tablets per shift of 8 hrs. or 12000 tabs. per hr

per machine.

31

Application – For Compression.

FIG. 7 SINGLE STROKE DOUBLE PUNCH MACHINE

III. PACKAGING SECTION:

BLISTER PACKING MACHINE:-

Mfg. By – Global packaging, Ahmedabad.

Capacity - Generally 50,000 tablets per hour.(Maximum

capacity 90,000 tab./hr.)

Application - For packaging

FIG. 8 BLISTER PACKING MACHINE

STRIP PACKING MACHINE:-

Mfg. By – Nimcho Engineers, Delhi.

Capacity - 15,000 tablets per hour

Application - For packaging

32

FIG. 9 STRIP PACKING MACHINE

It is commonly used for the packaging of tablet and capsule. A strip package is formed by

feeding two webs of a heat sealable flexible film through a heated crimping roller. The

product is dropped into the pocket formed before forming the final set of seals. A

continuous strip of packed is formed which is cut to the desired number of packets in

length.

The product sealed between the two sheets of film usually has a seal around each tablet.

The seal can be in a sample rectangular farm or can be made to the shape of the product.

The material used for strip package are poly propylene, polyvinyl chloride, cellophane,

polyester, polyethylene, and saran.

33

FLOW CHART FOR MANUFACTURING OF TABLET

Production Order

Dispensing of Raw Material

Weighing

Sifting

Mixing

Preparation of Starch Paste

Binding

Wet Granulation

Drying

Size Reduction

Sifting of Lubricants

Lubrication of Granules

Q.A. Testing

34

Compression

In Process Checking

Coating

Packing Order

Dispensing of Packing Material

Strip / Blister sealing

Strips ready Cartooning

Cartons transferred to Finished Goods Room

35

CHAPTER 4

CAPSULE

SECTION

36

CAPSULE SECTION

A capsule is solid unit dosage form in which the medicament is enclosed in water soluble

shell or envelope. These are made by filling the drugs as powder, granules and pellets

into a preformed cylindrical shell or body. The capsules are available both as hard capsule

and soft capsule.

Advantages of Capsules

A capsule is a very popular dosage form these days due to the following advantages:-

(1) The drugs having unpleasant odor and taste can be administered by enclosing them in

a tasteless shell.

(2) The capsules release the medicament as and when desired in gastro-intestinal tract.

(3) Capsules are made from gelatin and hence they are therapeutically inert.

(4) They can be filled quickly and conveniently therefore the physician can charge the

dose and combination of drugs to suit the individual patient. This is an advantage

over tablets.

Disadvantages of Capsules

(1) The hygroscopic drugs cannot be filled in capsules. They absorb water present in the

capsule shell and hence make it very brittle, which ultimately breaks into pieces.

(2) The concentrated preparations which need previous dilution are unsuitable for

capsules because it may lead to irritation in stomach if administered as such.

Gelatin:-

Gelatin is the major component of the capsule and has been the material from which they

have traditionally been made. The reason for this is that gelatin possesses five basic

properties:-

(1) It is non-toxic, widely used in foodstuffs, and acceptable for use worldwide.

(2) It is a good film-forming material, producing a strong flexible film. The wall

thickness of a hard gelatin capsule is about 100 μm.

(3) Solutions of high concentration, 40% w/v, are mobile at 50°C. Other biological

polymers, such as agar, are not.

TABLE: - 7 TYPES OF MATERIAL FOR FILLING INTO HARD GELATIN CAPSULES.

37

Types of material for filling into hard gelatin capsules.

Dry solids

Powders

Pellets

Granules

Tablets

Semisolids

Thermosoftening mixtures

Thixotropic mixtures

Pastes

Liquids

Non-aqueous liquids

TABLE:- 8 CAPSULE NUMBER & ITS APPROXIMATE CAPACITY

Capsule no. Approx. capacity in mg

000 950

00 650

0 450

1 300

2 250

3 200

4 150

5 100

This section is divided into sub section.

38

Mixing Section

Capsule Filling Section

Polishing Section

Mixing Section

Here the raw material is received from raw material room. The weighed amount of raw

material is issued according to the master card in request by the raw material store keeper.

After sifting and uniforming by the cone blender, the mixed material is then sent to the

capsule filling room.

Capsule Filling Section

The mixed material received from the mixing section is then dispensed as capsule by the

help of semi automatic capsule filing machine (Hand operated capsule filling machine).

Filling Capacity - 300 capsule at a time

Time (Single operation) - 1.5 – 2 minute

Output (in 8 hr.) – 60,000 to 70,000 capsules

Polishing Section and Dedusting Section

After the filling the capsule are sent to the polishing unit. Here capsules are inspected

and polished with the help of liquid paraffin.

PACKAGING SECTION

The finished capsules received from the filling section are packed into various packing

forms.

Strip packing

Blister packing

Bulk packing

PRATICAL TIPS

39

When humidity is very low, the capsule become brittle

If stored at high humidity, the capsule become flaccid and losses their shape.

Requirement for relative humidity is 50 +5% in capsule section.

The requirement for temp. 22 +1oC in capsule section.

Size very from 000 to 5. 000 is largest size and 5 is smallest size.

Stored in high temperature are can also affect the qualities of hard gelatin capsule.

FLOW CHART FOR PRODUCTION OF CAPSULE

40

Production Order

Dispensing of Raw Material

Weighing

Sifting

Q.A. Testing

Filling

Polishing

In process checking

Packing Order

Dispensing of Packing Material

Strip / Blister Packaging

Sorting of Blister or Strip Pack

Strips Ready Cartooning

Cartoon Transferred to Finished Goods Room

41

IN PROCESS QUALITY CONTROL TEST ACCORDING TO

I.P.1996

Uniformity of container contents (For Capsules)

Select a sample of ten containers and count the no. of Capsules in each container. The

avg. no. of the contents in the ten containers is not less than the labeled amount and the

no. in any single container is not less than 98% and not more than 102% of labeled

amount.

If the requirement is not met, count the no. of the contents in each of ten additional

containers. The avg. no. in the 20 containers is not less than the labeled amount and the

no. in not more than 1 of the 20 containers is less than 98% or more than 102% of labeled

amount.

Uniformity of Weight

This test is not applicable to capsules that are required to comply with the test for

uniformity of content for all active ingredients.

TABLE:- 9 WEIGHT VARIATION SPECIFICATIONS AS PER I.P. 1996

Average wt. of capsule contents Percentage deviation

Less than 300 mg 10

300 mg or more 7.5

Uniformity of Contents

Note - This test is applicable to capsule than contain less than 10 mg or less than 10%

w/w of active ingredients. This test is not applicable for capsule containing multivitamins

and trace elements.

Requirement – 10 capsule selected through random sampling.

42

Disintegration Test

TABLE- 10 DISINTEGRATION TEST SPECIFICATIONS

CAPSULE LIQUID at 37 ± 2`C DISINTEGRATION TIME

Hard Gelatin Water 30 min.

Soft gelatin Water 60 min.

Enteric Coated 0.1N HCl

Should show no disintegration for

2hrs.

Mixed Phosphate Buffer at pH=6.8 60 min.

LIST OF EQUIPMENTS IN CAPSULE SECTION:

Capsule Dedusting Machine

Hand Operated Capsule Filling Machine

Double Cone Blender

Capsule Filling Unit

Weighing Balance

Disintegration Apparatus

CAPSULE DEDUSTING MACHINE

43

FIG. 10 CAPSULE DEDUSTING MACHINE

In this procedure, capsules are fed under rotating soft brushes, which serve to remove the

dust from the capsule shell. This operation must be accompanied by a vacuuming for

dust removal. Some materials are extremely difficult to remove by brushing, even to the

point of impregnating the brushes and causing scratches or deformation of the capsules.

HAND OPERATED CAPSULE FILLING MACHINE

OPERATION PROCEDURE (HAND OPERATED CAPSULE FILLING

MACHINE)

Loaded the empty capsule in loading tray.

Ensured that the inner side knob was pulled out with the help of cam liver the bodies

of capsules got tight and even grip.

Pushed the inner side knob in

By depressing lifting plate level, separate the capsule from bodies.

44

FIG.-11 HAND OPERATED CAPSULE FILLING MACHINE

i) Released the liver.

ii) Poured the pre weighed powder required for 300 capsules into powder tray.

iii) Rotated pin plate handle clock wise to compress powder in capsule bodies.

iv) Capsules were filled fully with the powder.

v) Remove powder tray replaced with loading tray with caps.

vi) By locking liver proper locking of capsule were done.

vii) Polishing and finishing was done.

Capsules were packed by strip blister packaging machine.

Label Printing Machine

M.R.P , manufacturing date, expiry date and batch no. are printed on the label by using

hand operated label printing machine.

RECORDS:-

The production in charge maintain following records in capsules section –

Flow sheet for entry of ingredients.

45

In process control sheets

Raw material issuer sheet

Packing material sheet

Sheet for finished goods store in ware house.

46

CHAPTER 5

LABELLING

LABELLING

47

The term ‘labelling’ means all labels and other written, printed, or graphic matter upon

any article or any of its containers or wrappers, or accompanying such articles.

The containers of all the drugs including patent or proprietary medicine are to be labeled

in accordance with the D&C rules 1945. Following particulars should be either printed or

written in indelible ink and should appear in a conspicuous manner on any drug and en

every other covering in which the container is packed.

Proper name of the drug.

Net contents in terms of wt., measure, volume, no. of units of

activity (In metric system.)

Content of active ingredients.

The name and address of the manufacturer.

Manufacturing license number or Mfg. Lic. No. or M.L.

Batch number – ‘ Batch no.’ or ‘B. No.’ or ‘Batch’ or ‘Lot no.’ or ‘

Lot’.

Expiry particulars, if any.

Precautionary information.

Storage conditions and manner of use.

General information such as ‘Physician’ sample, not for sale’ etc.

If the pack is not already printed, labeling normally follows

closuring.

48

CHAPTER 6

QUALITY CONTROL

&QUALITY

ASSURANCE

QUALITY CONTROL

49

The professional, social and legal responsibilities that rest with the pharmaceutical

Manufacturing for the assurance of product quality is tremendous. It is only through

well-organized, adequately staffed and accurately performed process and dosage form

control before, during and after production that adequate quality assurance of the product

can be achieved. It should be realized that no amount of dosage form testing and control

can maintain and assure products quality unless good manufacturing practices are

implemented systematically and process control is practiced vigorously. Products quality

must be built into, and not merely in the products.

The manufacturer can maintain the quality of his products by executing the

following functions: -

To control the sources of product quality, variation mainly in methods, machines

and men.

To ensure the correct and most appropriate, manufacturing and packaging

practices.

To assure that the testing results are in compliance with the standards or

specifications.

To assure the products stability and to perform other activities related to product

quality through a well-organized total quality assurance system.

In order that the quality control tests of the sample be indicative of the whole, proper

sample selection is essential. Usually two samples are chosen randomly from each batch

of capsules, tablets and liquids. The first samples is meant for immediate quality control

testing, whereas the second is intended to be maintained under appropriate storage

conditions to determine whether or not the samples

50

QUALITY CONTROL LABORATORY

Q.C. refers to the process of striving to produce a perfect product by a series of measures

requiring an organizes effect by the entire company or eliminate errors at every stage in

production .

Q.C. is the part of GMP concerned with sampling, specification and testing with the

organization, documentation and release procedure.

Various quality control parameter of the “Liquid and Solid” dosage form was evaluated.

The instruments that was in quality control laboratory are:-

51

QUALITY ASSURANCE

The assurance of product quality depends on more than just proper sampling and

adequate testing of various components and the finished dosage form prime responsibility

of maintaining product quality during production rest with the manufacturing department.

Removal of responsibility from manufacturing for producing a quality product can result

in imperfect composition, such as ingredient missing, sub potent or super potent addition

of ingredients or mix up of ingredients, mistakes in packaging or filling, such as product

contamination, mislabeling or deficient package and lack of conformance to product

registration. Quality assurance personnel establish control or check points to monitor the

quality of the product as it is processed and upon completion of manufacturing. These

begin with raw material and component testing and include in process, packaging,

labeling and finished product testing as well as back auditing and stability monitoring.

52

CHAPTER 7

STORE ROOM

53

STORE ROOM

RAW MATERIAL STORE ROOM:

The store room is the place where various materials are stored and preserved until they

are issued to the other departments. The area of a storeroom depends upon the nature and

capacity of the organization, nature of the item to be stored, frequency of purchasing and

issuing of the items. The quantity to be stored, nature of finished products etc. This unit

has a centralized store room consisting of a better control, better layout, less space, staff,

economy and better stock checking is rendered.

The storeroom is almost in the center of the unit and near the section so that

transportation of raw materials from store to various sections become very easy &

economic. In generally it consists of bulk drugs, raw materials coloring agents, flavoring

agents, sweetening agents, various suspending agents tools and spare parts of machine

etc. The materials such as coloring and flavoring agents, patent drugs, tools are stored in

specific metal, plastic, rubber and cardboard boxes in shelves and racks. The store is

categorized in zones for proper handling of the material.

The materials are issued to the production departments and the other departments as and

when desired by them. This section also maintains an up to date record of receipts and

issue of materials. The materials issued from the store are recorded. For maintaining an

up to date records, a store ledger is used. It provides information regarding the A/c

number of item, description of item, maximum, minimum and recorder and recorder

level, quantity received with date, quantities issued with date, batch no. regarding the

materials used all other necessary information.

PACKAGING MATERIAL STORE ROOM

An independent packing materials preparation and storage arrangements systems

was available at Jyoti remedies. Interestingly, the various packing materials, among

which the card board cartons of differing sizes were prepared at the first floor of the plant.

The packing materials included bottles, plastic boxes

54

CHAPTER 8

DOCUMENTATION

SECTION

55

DOCUMENTATION SECTION

DOCUMENTATION AND RECORDS:

Documentation is an essential part of the Quality Assurance system and, as such, shall be

related to all aspects of Good manufacturing practices (GMP). Its aim is to define the

specifications for all materials, method of manufacture and control, to ensure that all

personnel concerned with manufacture know the information necessary to decide whether

or not tot release a batch of a drug for sale and to provide an audit trail that shall permit

investigation of the history of any suspected defective batch.

DOCUMENTS REQUIRED

i) Labels

ii) Specifications & testing procedures

iii) Specifications for starting & packing materials

iv) Specifications for intermediate & bulk products

v) Specifications for finished products

vi) Master formulae

vii) Packing instructions

viii) Batch processing records

ix) Batch packaging records

x) Standard operating procedures ( SOPs) & records

xi) Miscellaneous

All these documents are maintained in the factory according to the legal requirements.

1. Master Formula Record:

To assure uniformity from batch to batch master formula (master production and control)

records for each drug product.

Procedure:

It is to be described in a written procedure and such written procedure shall be dated and

signed by competent technical staff and independently checked, checked dated and signed

by second person. Master formula record shall includes

56

i) Name and Strength of the product along with dosage form (if it is pharmacopoeial

product under trade name, both names will be given)

ii) The name and wt. measure of active ingredients per dosage unit or per unit

weight/measure of the product and tablet weight/measure of any dosage unit.

iii) A complete list of all the ingredients to be used in the manufacture of the product

indicating any special quality characteristics.

iv) An accurate statement of weight/measure of each ingredient (same weight system

should be used) required as per formula of dosage form and the weight/measure

actually to be used (e.g. overages to compensate losses during storage).

v) A statement of theoretical weight/measure at appropriate phase of processing.

vi) A statement of theoretical yield including permissible limits beyond which

investigation is required.

vii) A description of containers, closures and packaging materials to be used.

viii) A description of all vessels, equipments to be used in their preparation.

ix) Processing and packaging procedures.

x) In process controls to be exercised during processing and packaging.

xi) Precautions to be taken during manufacture and storage of semi-finished product.

2. Batch Manufacturing Records:-

Batch manufacturing records as per Schedule U are prepared for each batch of the drug

product. These should be based on master formula records. Method of preparation of

batch processing records should be such that transcription errors do not occur.

During the manufacturing information listed below should be recorded, signed and dated

by the persons responsible for processing operations:-

name of the product

batch number

date of commencement & completion of significant intermediate stages

name of the person responsible for each stage of production

57

initial of operators who carried out significant processes and initial of persons who

checked, wherever applicable.

Quantity, batch number, quality control report number of each ingredient actually

weighed and amount of any recovered material added.

In –process controls carried out their results and signature of person who performed.

Theoretical yield and actual yield at appropriate stage of production together with

explanation. If variation beyond expectation observed.

Authorization of any deviation if made.

HYGIENE & SANITATION

The factory was cleaned every morning with disinfectant and water.

Double door system was used in liquid section & capsule section to reduce the level of

recontamination.

Air curtain installed at the entrance of factory to reduce the dust content on cloths of

labor.

These were separate change room for men and women.

The kitchen of the factory was situated on first floor so as to reduce contamination.

Exhaust air, air conditioner, humidity meter were installed of various place in the factory.

Fire extinguisher was hanged on the wall of gallery.

58

CHAPTER 9

MARKETED

PRODUCTS

TABLE:- 11 LIST OF MARKETED PRODUCT

Brand Name Contents Pkg

Zeeclox LB capAmoxycillin 250mg,Cloxacillin 250mg, Lactic Acid

Bacillus 1.7 Billion capsuleCaps of 10s

59

Zeemox 250 cap Amoxycillin 250mg capsule Caps of 10s

Zeemox 500 cap Amoxycillin 500mg capsule Caps of 10s

Panlee DSRPantaprazole 40mg,Domperidone 30mg 

sustained release capsuleCaps of 10s

Rabdom-DRabeprazole 20 mg  & Domperidone 

10 mg Cap10x10C

Rabdom-DSRRabeprazole 20 mg & Domperidone 

30 mg Cap10x10C

DobeflowCalcium Dobesilate Monohydrate

 BP 500 mg10x10C

Maxslim 60 Orlistat 60mg Capsules 10x10C

Maxslim 120 Orlistat 120mg Capsul;es 10x10C

Ferest-100 Cap Natural Micronised Progesterone 10x10C

Ferest-200 Cap Natural Micronised Progesterone 10x10C

Ecorich softulesVitamin E Acetate IP 400mcg & Code

 liver oil BP 300mg

Softules of

10s

LipocinMethylcobalamin,Folic Acid,Vitamins B6 & Alpha

Lipoic Acid10x1x10C

Lycomax-PlusLycopene,LArginine,Betacarotene,Lutein,Vitamins

& Minerals10x1x10C

Pregmax-M Pregablin 75mg with Methylcobalamin 750 mcg 10x1x10C

Gabamax-M cap Gabapentin 300mg & Methylcobalamin 500mcg 10x1x10C

Maxtil 100 Cefpodoxime Proxetil USP 100mg DT Tablet 10x10T

Maxtil 200 Cefpodoxime Proxetil USP 200 mg tablet 10x10T

Roxime 250 tab Cefuroxime Axetil  250 mg tablet 10x10T

Roxime 500 tab Cefuroxime Axetil 500 mg tablet 10x10 T

Ceftis-200 Cefixime 200 mg Tablets 10x10T

Maxflox -200 Ofloxacin  200 mg tablet (Alu-Alu) 10x10T

Maxflox-400 Ofloxacin 400 mg tablet (Alu-Alu) 10x10T

Maxflox-O Ofloxacin 200 mg & Ornidazole 500 mg Tab 10x10T

Levomax 500 Levofloxacin 500 mg Tablets (Alu-Alu) 10x10T

Rabrol Rabeprazole 20 mg (Alu-Alu) 10x10T

Citrocalcium Alfacalcidol & Calcium Citrate Tablets 10x10T

Lubrilax Tab Sodium Picosulphate BP 10mg tablet 10x10T

Swiftase Tab Serratiopeptidase 10mg tablets 10x10T

60

Swiftact SDiclofenac50 mg, Serratiopeptidase 

10 mg tablets10x10T

Swiftact 3D

Diclofenac Pottassium 50 mg & 

Serratiopeptidase 15 mg & 

Paracetamol 325 mg Tablets

10x10T

Swiftok

Diclofenac Pottassium 50mg, PCM 500mg,

Chlorzoxazone 250mg, Magnesium Trisilicate 100

mg Tablets

10x10T

Petra Plus tab Tramadol 50mg,Paracetamol IP 500mg 10x10T

Nimbra Nimesulide Tablets 25x10T

Nimbra Plus Nimesulide & Paracetamol Tablets 25x10T

HB Rise TabFerrous Ascorbate eq.to elemental

 iron 100mg,Folic Acid IP 1.5mg Tablet10x10T

NovacalAlfacalcidol 0.25mcg & Calcium Citrate 1200mg

Tablets10x10T

Balaneuron-Forte

Benfotiamine,Methylcobalamin

Adenosylcobalamin,Folic acid,Pyriodoxine

Hydrochloride

10x10T

Zeeclox Kid LB

tab

Amoxycillin 125mg,Cloxacillin 125mg,

Lactic Acid Bacillus 1.7 Billion tabletsTabs of 10s

Zeemox 250 DT Amoxycillin 250mg Dispersible tab Tabs of 10s

Zeemox CV 625Amoxycillin 500mg, Clavulanic Acid 

125mg tabletTabs of 10s

Zithmax 500 tab Azithromycin 500mg tablet Tabs of 10s

Zeemol 650 Paracetamol 650mg Tabs of 10s

Mefmol PlusMefenamic Acid IP 500mg,Paracetamol

IP 450mgTabs of 10s

61

CHAPTER 10

WORK DONE

UNDER

PRACTICAL

TRAINING

WORK DONE UNDER PRACTICAL TRAINING

“Accept challenges, so you can feel the joy of victory” this is right for me, when I go to

this industry “JYOTI REMEDIES”. As it was challenge for me to join this, after joining I

62

feel that I have gained much more knowledge about the pharmacy & works handled in

industry. There was a complete friendly nature of the men power of industry.

The factory was cleaned every morning with disinfectant & water, so that hygienic

environment can be made. I am very grateful to Mr. C.P. Kuriakose (M.D.) & Mr. Sudhir

Sharma (M.D.) who give me complete guidance which was necessary for me in

completion of this training. JYOTI REMEDIES has bright future as it is among the fastest

growing pharmaceutical companies.

TABLET :-

Brand Name – Mefmol Plus

ANTI-INFLAMATORY, ANALGESIC

Each uncoated tablet contains:

Mefenamic Acid I.P. 500 mg

Paracetamol I.P. 450 mg

Formula for 58,000 tablets:

For 1 tablet, Mefenamic Acid I.P. = 500 mg

For 58,000 tablets, Mefenamic Acid I.P. = 500*58,000= 29.0 Kg

For 1 tablet Paracetamol I.P. = 450 mg

For 58,000 tablets, Paracetamol I.P. = 450*58,000=26.10 Kg

Total active ingredients = 55.10 Kg

Wt. Of 1 tab. = 1.20 gm

Total Wt. = 1.20*58,000=69.6 Kg

Lubricants:

1) Talc - 2.73%

63

For 58,000 Tablets,

(2.73*69.6)/100 = 1.9 Kg.

2) Magnesium stearate - 1.27%

For 58,000 Tablets,

(1.27*69.6)/100 = .88 Kg.

3) Aerosil - 0.907%

For 58,000 Tablets,

(0. 907*69.6/100 = 500 gm

Total lubricants used = 0.63 Kg

Disintegrants:

Starch - 4.53%

For 58,000 Tablets,

(4.53*69.6)/100 = 3.15 Kg.

Binders:

1) Starch - 4. %

For 58,000 Tablets,

(4*69.6)/100 = 2.78 Kg.

2) Gelatin – 1%

For 58,000 Tablets,

(1*69.6)/100 = 0.7 Kg.

Moisture content:

Moisture - 2 %

64

For 58,000 Tablets,

(2*69.6)/100 = 1.39 Kg.

Preservative:

Sodium benzoate - 0.0324 %

For 58,000 Tablets,

(0.0324*69.6)/100 = 0.02 gm.

Diluents:

1) Talc - 2.125 Kg.

2) Starch - 2.125 Kg.

65

CHAPTER 10

CONCLUSION

CONCLUSION

66

As we all know the main purpose of industrial training is to improve the practical skill of

the trainee and to acquire him with the environment of the industry and to develop

professionalism.

Working in Jyoti remedies as a trainee was an excellent experience. I had learnt many

new techniques regarding formulation of Tablet & capsule dosage forms. The location

and layout of factory was according to the GMP requirements. The technical staff of the

factory was very talented, expert in their work. All the employees and workers were very

cooperative, disciplined and professional.

The Q.C. section was well equipped and all the standards and Q.C. Tests were performed

according to the official pharmacopoeias very strictly.

In my opinion Jyoti remedies has wide scope for more development in upcoming years

and future of the company is bright because of good management and skilled staff in

production department.

67

BIBLIOGRAPHY

BIBLIOGRAPHY

68

1. Indian Pharmacopoeia, Government of India, Ministry of Health and Family

Welfare, The controller of Publication, 1996, New Delhi.

2. Lachman, L. and Libberman, A. (1991) The Theory and Practice of Industrial

Pharmacy, Varghese Publishing House, Bombay.

3. Remington’s – The science and practice of pharmacy, international student

edition, 20th ed., 2000 Philadelphia College of Pharmacy and Science,

Philadelphia.

4. Ansel’s Pharmaceutical Dosage forms and Drug Delivery Systems’ 8 th ed.,

B.I. Publications Pvt. Ltd., Lippincott Williams and Wilkins, Philadelphia.

5. Bentley’s Text book of Pharmaceutics, 8th ed., Published by All India

Traveller Book Seller, Delhi.

6. Aulton, M. Pharmaceutics – The science of Dosage from Design International

Student edition, London.

7. Kohli, D.P.S. and Shah, D.H., Drug formulations, Manual Eastern Publishers,

New Delhi.

8. Mithal B.N., ‘Text Book of Pharmaceutical Formulation, Vallabh Prakashan,

Delhi.

9. United State Pharmacopoeia, 23rd edition.

10. P.P. Sharma – How to practice GMP (Good Manufacturing Practices) 4 th Ed.,

Vandana Publication Pvt. Ltd., Delhi P.No. 55-57, 215-296

69