m.pharm qa new syllabus a.y. 2013-14

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ACADEMIC

REGULATIONS

&

SYLLABUS

Faculty of Pharmacy

Master of Pharmacy Programme (Quality Assurance)

From Academic Year–2013-14

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CHAROTAR UNIVERSITY OF

SCIENCE & TECHNOLOGY

Education Campus – Changa, (ECC), hitherto a conglomerate of institutes of professional education

in Engineering, Pharmacy, Computer Applications, Management, Applied Sciences, Physiotherapy

and Nursing, is one of the choicest destinations by students. It has been transformed into Charotar

University of Science and Technology (CHARUSAT) through an Act by Government of Gujarat.

CHARUSAT is permitted to grant degrees under Section-22 of UGC- Govt. of India.

The journey of CHARUSAT started in the year 2000, with only 240 Students, 4 Programmes, one

Institute and an investment of about Rs. 3 Crores (INR 30 million). At present there are seven

different institutes falling under ambit of six different faculties. The programmes offered by these

faculties range from undergraduate (UG) to Ph.D degrees including M.Phil. These faculties, in all

offer 32 different programmes. A quick glimpse in as under:

Faculty Institute Programmes

Offered

Faculty of Technology &

Engineering

Chandubhai S. Patel Institute of

Technology B.Tech M.Tech

Ph.D Faculty of Pharmacy Ramanbhai Patel College of Pharmacy B.Pharm

M.Pharm

Ph.D Faculty of Management Studies Indukaka Ipcowala Institute of

Management M.B.A

PGDM

Ph.D Faculty of Computer Applications Smt. Chandaben Mohanbhai Patel

Institute of Computer Applications M.C.A.

M.Sc.(IT) Ph.D

Faculty of Applied Sciences P. D. Patel Institute of Applied Sciences M.Sc

M.Phil Ph.D

Faculty of Medical Sciences Charotar Institute of Physiotherapy

Manikaka Topawala Institute of Nursing

B.PT

B.Sc (Nursing)

G.N.M. The development and growth of the institutes have already led to an investment of over Rs.80 crores

(INR 800 Million). The future outlay is planned with an estimate of Rs. 250 Crores (INR 2500

Million). The University is characterized by state-of-the-art infrastructural facilities, innovative

teaching methods and highly learned faculty members. The University Campus sprawls over 105

acres of land and is Wi-Fi enabled. It is also recognized as the Greenest Campus of Gujarat.

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CHARUSAT is privileged to have 350 core faculty members, educated and trained in IITs, IIMs and

leading Indian Universities, and with long exposure to industry. It is also proud of its past students

who are employed in prestigious national and multinational corporations.

From one college to the level of a forward-looking University, CHARUSAT has the vision of entering

the club of premier Universities initially in the country and then globally. High Moral Values like

Honesty, Integrity and Transparency which have been the foundation of ECC continue to anchor

the functioning of CHARUSAT. Banking on the world class infrastructure and highly qualified and

competent faculty, the University is expected to be catapulted into top 20 Universities in the coming

five years. In order to align with the global requirements, the University has collaborated with

internationally reputed organizations like Pennsylvania State University – USA, University at

Alabama at Birmingham – USA, Northwick Park Institute –UK, ISRO, BARC, etc.

CHARUSAT has designed curricula for all its programmes in line with the current international

practices and emerging requirements. Industrial Visits, Study Tours, Expert Lectures and Interactive

IT enabled Teaching Practice form an integral part of the unique CHARUSAT pedagogy.

The programmes are credit-based and have continuous evaluation as an important feature. The

pedagogy is student-centred, augurs well for self-learning and motivation for enquiry and research,

and contains innumerable unique features like:

• Participatory and interactive discussion-based classes. • Sessions by visiting faculty members drawn from leading academic institutions and industry.

• Regular weekly seminars. • Distinguished lecture series.

• Practical, field-based projects and assignments. • Summer training in leading organizations under faculty supervision in relevant programmes.

• Industrial tours and visits.

• Extensive use of technology for learning. • Final Placement through campus interviews.

Exploration in the field of knowledge through research and development and comprehensive

industrial linkages will be a hallmark of the University, which will mould the students for global

assignments through technology-based knowledge and critical skills.

The evaluation of the student is based on grading system. A student has to pursue his/her programme

with diligence for scoring a good Cumulative Grade Point Average (CGPA) and for succeeding in the

chosen profession and life.

CHARUSAT welcomes you for a Bright Future

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CHAROTAR UNIVERSITY OF SCIENCE AND TECHNOLOGY

Faculty of Pharmacy

ACADEMIC REGULATIONS M. Pharm. (Quality Assurance) Programme

Charotar University of Science and Technology (CHARUSAT) CHARUSAT Campus, At Post: Changa – 388421, Taluka: Petlad, District: Anand

Phone: 02697-247500, Fax: 02697-247100, Email: [email protected] www.charusat.ac.in

Year – 2013-14

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CHARUSAT

FACULTY OF PHARMACY ACADEMIC REGULATIONS

M. Pharm. (Quality Assurance) Programme

To ensure uniform system of education, duration of post graduate programmes, eligibility criteria for and mode of admission, credit load requirement and its distribution between courses and system of examination and other related aspects, following academic rules and regulations are recommended.

1. System of Education

The Semester system of education should be followed across The Charotar University of Science and Technology (CHARUSAT) at Master’s levels. Each semester will be at least of 90 working days duration. Every enrolled student will be required to take a specified load of course work in the chosen subject of specialization and also complete a project/dissertation if any. 2. Duration of Programme

Postgraduate programme (M.Pharm)

Minimum 4 semesters (2 academic years) Maximum 6 semesters (3 academic years)

Maximum limit can be extended by one or two semesters subject to approval of University on case to case basis.

3. Eligibility for admissions

As decided from time to time by the Government of Gujarat and CHARUSAT

4. Mode of admissions

As decided from time to time by the Government of Gujarat and CHARUSAT

5. Programme structure and Credits A student admitted to a program should study the courses and earn credits specified in the course structure. Please refer detailed syllabus.

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6. Attendance

All activities prescribed under these regulations and listed by the course faculty members in their respective course outlines are compulsory for all students pursuing the M. Pharm. programme. No exemption will be given to any student from attendance except on account of serious personal illness or accident or family calamity that may genuinely prevent a student from attending a particular session or a few sessions. However, such unexpected absence from classes and other activities will be required to be condoned by the Principal.

Student attendance in a course should be 80%.

7. Course Evaluation 7.1 The performance of every student in each course will be evaluated as follows:

7.1.1. Internal evaluation by the course faculty member (s) based on continuous assessment, for 30% of the marks for the course; and

7.1.2 Final examination by the University through written paper or practical test or oral test or presentation by the student or a combination of any two or more of these, for 70% of the marks for the course.

7.1.3 Theory and Practical component of the same course shall be considered as separate courses.

7.2 Internal Evaluation (Theory)

The distribution of marks for calculating the internal marks in every course of theory shall be:

Test * 20 Marks Seminar/quiz/viva 10 Marks ___________________________________________________________________________

Total 30 Marks

* One test (60 marks, 2.5 hours duration) shall be conducted as per the schedule to be notified by the institute for every course in a semester.

7.3. Internal evaluation (Practicals)

The distribution of marks for calculating the internal marks in every course of practical shall be:

Performance of the exercises * 15 Marks Viva 10 Marks Quiz 05 Marks

Total 30 Marks

*One test (60 marks, 6 hours duration) shall be conducted as per the schedule to be notified by the Institute for every course of practical in a semester.

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7.4 University Examination

7.4.1 The final examination by the University for 70% of the evaluation for the course will be through written paper or practical test or oral test or presentation by the student or a combination of any two or more of these.

In order to earn the credit in a course a student has to obtain grade other than FF.

7.5 Performance at University Examination

7.5.1 Minimum performance with respect to university examination as well as overall (university + internal) will be an important consideration for passing a course.

Details of minimum percentage of marks to be obtained in the examinations are as follows:

Minimum marks in University Examination for every course

Minimum marks Overall (internal + university examination) for every course

40% 50%

7.5.2 If a candidate obtains minimum required marks per course in university examination but fails to obtain minimum required overall marks, he/she has to repeat the university examination till the minimum required overall marks are obtained.(As per the clause 7.5.1)

8. Grading

8.1 The total of the internal evaluation marks and final University examination marks in each course will be converted to a letter grade as well as to a ten-point scale as per the following scheme:

Grading Scheme:

Range of Marks (%) ≥80 <80 ≥75

<75 ≥70

<70 ≥65

<65 ≥60

<60 ≥55

<55 ≥50

<50

Letter Grade AA AB BB BC CC CD DD FF Grade Point 10 9 8 7 6 5 4 0

8.2 The student’s performance in any semester will be assessed by the Semester Grade

Point Average (SGPA). Similarly, his/her performance at the end of two or more consecutive semesters will be denoted by the Cumulative Grade Point Average (CGPA). The SGPA and CGPA are defined as follows:

(i) SGPA = ∑ Ci Gi / ∑ Ci where Ci is the number of credits of course i

Gi is the Grade Point for the course i and i = 1 to n, n = number of courses in the semester

(ii) CGPA = ∑ Ci Gi / ∑ Ci where Ci is the number of credits of course i Gi is the Grade Point for the course i

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and i = 1 to n, n = number of courses of all semesters up to which CGPA is computed.

No student will be allowed to move further if CGPA is less than 3 at the end of every academic year.

9. Award of Degree

9.1 Every student of the programme who fulfils the following criteria will be eligible for the award of the degree: 9.1.1 He/She should have earned at least minimum required credits as prescribed in

course structure; and 9.1.2 He/She should have cleared all external and overall evaluation components in

every course; and He/She should have secured a minimum CGPA of 5.0 at the end of the programme; In addition to above, the student has to complete the required formalities as per

the regulatory bodies, if any.

9.2 The student who fails to satisfy minimum requirement of CGPA will be allowed to improve the grades so as to secure a minimum CGPA for award of degree. Only latest grade will be considered.

10. Award of Class

The class awarded to a student in the programme is decided by the final CGPA as per the following scheme: Distinction: CGPA ≥ 7.5 First class: CGPA≥ 6.0 & <7.5 Second Class: CGPA≥ 5.0 & <6.0

11. Transcript The transcript issued to the student at the time of leaving the University will contain a consolidated record of all the courses taken, credits earned, grades obtained, SGPA,CGPA, class obtained, etc.

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CHAROTAR UNIVERSITY OF SCIENCE & TECHNOLOGY

M. Pharm. (Quality Assurance)

SEMESTER-I

Scheme of Teaching

Scheme of Evaluation

Course Theory Practical

Code Name University Institute

Total University Institute Total Theory Seminar

Ph816.01 Modern Analytical Techniques 70 30 - 100 - - -

PH816.02 QA, GMP, GLP 70 20 10 100 - - -

PH816.03 Pharmaceutical Analysis–I 70 20 10 100 - - -

PH816.04 Clinical research and Drug regulatory affairs

70 30 - 100 - - -

PH816.05 Practical-I (Modern analytical Techniques and Biostatistics)

- - - - 70 30 100

PH816.06 Practical-II (Pharmacopoeial methods of Analysis)

- - - - 70 30 100

PH824.01 Scientific Communication -

- -- -

-- 50 50

PH824.02 Community Services-I -

- -- -

-- 50 50

Total 280 100 20 400 140 160 300

Total marks of 1st semester:700

Course Contact Hours/Week Credits

Code Name Theory Seminar Practical Total Theory+

Seminar Practical Total

PH816.01 Modern Analytical Techniques 4 -- -- 4 4 --- 4

PH816.02 QA, GMP, GLP 4 1 -- 5 5 --- 5

PH816.03 Pharmaceutical Analysis - I 4 1 -- 5 5 ---- 5 PH816.04 Clinical research and Drug

regulatory affairs 4 -- -- 4 4 ---- 4

PH816.05 Practical-I (Modern analytical Techniques and Biostatistics)

-- -- 6 6 --- 3 3

PH816.06 Practical-II (Pharmacopoeial methods of Analysis)

-- -- 6 6 --- 3 3

PH824.01 Scientific Communication - - 3 3 - 1 1 PH824.02 Community Services-I - - 3 3 - 1 1

Total 16 2 18 36 18 8 26 Total credits of 1st semester= 26

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SEMESTER-II

Scheme of Teaching


Course Theory Practical

Code Name University Institute

Total University Institute Total Theory seminar

PH824.03 Research methodology-IPR 70 30 - 100 - - -

PH816.07 Pharmaceutical Validation and Documentation 70 20 10 100 - - -

PH816.08 Pharmaceutical Analysis-II 70 20 10 100 - - -

PH816.09 Quality Management of Pharmaceuticals 70 30 - 100 - - -

PH816.10 Practical-III (Advanced Pharmaceutical Analysis)

- - - - 70 30 100

PH816.11 Practical IV (Pharmaceutical Validation & Documentation)

- - - - 70 30 100

PH824.04 Community services -II -

- --

-- 50 50

PH816.12 Dissertation part-I -

- --

-- 50 50

Total 280 100 20 400 140 160 300

Total marks of 2nd semester:700


Code Name TheorySeminar Practical Project Total Theory+

Seminar

Practical +

Project

Total

PH824.03 Research methodology& IPR 4 - - - 4 4 - 4

PH816.07 Pharmaceutical Validation and Documentation

4 1 - - 5 5 - 5

PH816.08 Pharmaceutical Analysis-II 4 1 - - 5 5 - 5 PH816.09 Quality Management of

Pharmaceuticals 4 -- - - 4 4 - 4

PH816.10 Practical-III (Advanced Pharmaceutical Analysis)

- - 6

- 6

- 3 3

PH816.11 Practical IV (Pharmaceutical Validation & Documentation)

- - 6

- 6

- 3 3

PH824.04 Community Services II - - 3 - 3 - 1 1 PH816.12 Dissertation

part –I - -

- - 3 -

3 3

Total 16 2 12 3 36 18 10 28 Total Credit of 2nd Semester: 28

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SEMESTER-III

Scheme of Teaching

Course Contact Hours/Week Credits Code

Name Theory

Practical Project Total Theory Practical Project Total

PH916.01 Dissertation Part-II -- -- 36 36 - - 25 25 Total -- -- 36 36 - - 25 25

Total credits: 25


Course Theory Practical Project

University Institute Total University Institute Total University Institute Total Code Name

PH916.01 Dissertation Part-II

- - - - - - 150 100 250

Total 150 100 250 Total marks of 3rd semester : 250

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SEMESTER-IV

Scheme of Teaching

Part I: 10 weeks


Code Name Theory Practical Project Total Theory Practical Project Total PH916.02 Dissertation Part-III -- -- 36 36 -- -- 25 25

Part II: 5 Weeks

PH916.03 Industrial Training -- -- -- -- -- -- 2 2

Total -- -- -- -- -- -- 27 27

Total Credit : 27


Course

Theory Practical Project

University Institute Total University Institute Total University Institute Total

Code Name

PH916.02 Dissertation

Part-III -- -- -- -- -- -- 150 100 250

PH916.03 Industrial Training -- -- -- -- -- -- 50 50

Total -- -- -- -- -- -- 150 150 300

Total Marks of 4th Semester : 300


SYLLABI (Semester–1)


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SEMESTER-I MODERN ANALYTICAL TECHNIQUES (PH816.01)

Credits: 4: Theory Contact Hours Per week: 4: Theory

Objective of the Course:

To make students familiar with the principles of modern analytical techniques and their

application in pharmacy.

Student Learning Outcomes/Objectives: At the end of the course, the student will be able to understand the fundamental concept of

modern analytical techniques, which is important for qualitative as well as quantitative analysis

of drug substances and drug product.

Instructional Methods and Pedagogy: Faculty member/s shall explain in a class room using black board and multimedia projector. Outline of the Course:

No. Unit Minimum No.

of Contact Hours Approx.

Weightage % 1 UV – Visible spectroscopy 8 14 2 Spectrofluorimetry 3 5 3 Infrared spectroscopy 5 8

4 Nuclear Magnetic Resonance Spectroscopy

9 14

5 Mass Spectroscopy 9 14 6 Thermal Methods of Analysis 4 8 7 X-Ray Diffraction Methods 2 4 8 Chromatographic techniques 14 24 9 Electrophoresis 4 6 10 Radiochemical Analysis 2 3

Total 60 100 %

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Detailed Syllabus (Theory):

1. UV – Visible spectroscopy: 8

Theory, chromophores and their interaction with EMR, factors affecting absorption spectra: effect of slit width and scattered radiations, factors affecting absorption maxima: conjugation, pH, solvent; Recent advancements in Instrumentation & applications including multi-component assay and derivative spectroscopy. Woodward-Fischer rules for calculating absorbance maximum and interpretation of spectra.

2. Spectroflourimetry: 3

Theory, factors affecting intensity of excitation and emission, stokes shift, quenching, instrumentation, applications

3. Infrared spectroscopy: 5

FTIR: Introduction, basic principles, instrumentation (components and their function), sampling techniques and accessories, interpretation of spectra and applications.

4. Nuclear Magnetic Resonance Spectroscopy: 9

Fundamental principle and theory of proton NMR, instrumentation, solvents, chemical shift, spin-spin coupling, coupling constant, spin-spin decoupling, proton exchange reactions, FT-NMR, 2D-NMR, applications in pharmacy and interpretation of spectra. 13 C-NMR introduction, natural abundance, 13 C-NMR spectra and its structural applications.

5. Mass Spectroscopy: 9

Basic principle and instrumentation, ion formation and type, fragmentation process and fragmentation pattern, chemical ionization mass spectroscopy (CIMS), field ionization MS (FIMS), Fast atom bombardment MS (FAB-MS), matrix assisted laser desorption/ ionization MS (MALDI-MS), Interpretation of spectra and application in pharmacy, Surface Ionization MS(SI-MS).

6. Thermal Methods of Analysis: 4

Theory, instrumentation and application of thermogravimetric analysis (TGA), Differential Thermal Analysis (DTA), Differential Scanning Calorimetry (DSC) and Thermo Mechanical Analysis (TMA).

7. X-Ray Diffraction Methods: 2

Introduction, generation of X-rays, X-ray diffraction, Bragg’s Law, X-ray powder diffraction, interpretation of diffraction pattern and applications.

8. Chromatographic techniques: 14

Classification of chromatographic methods based on mechanism of separation. Theories of

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chromatographic separation. Principle, elution techniques, instrumentation, derivatization and application of GC, HPLC and the related troubleshooting and HPTLC. Principles, elution techniques, applications of ion exchange and ion pair chromatography, affinity chromatography, Size exclusion chromatography, chiral chromatography, super fluid chromatography (SFC), short column chromatography, flash chromatography.

9. Electrophoresis: 4

Theory and principles, classifications, instrumentation, moving boundary electrophoresis, Zone Electrophoresis (ZE), Capillary Electrophoresis, Isoelectric focusing (IEF), Micellar kinetic capillary electrophoresis and applications.

10. Radiochemical Analysis: 2

Importance of Radioisotopes in medicine, Instrumentation and analysis methods, Radio isotopic analysis, radioimmunoassay, Enzyme immunoassay-ELISA and EMIT

Recommended study materials:

1. Principles of Instrumental Analysis, Skoog, Hollar and Nieman, Saunders College

Publishers, Philadelphia.

2. Instrumental Methods of Analysis, Willard, Merritt, Dean and Settle, CBS publishers and

Distributors, Delhi.

3. Instrumental Methods of Chemical Analysis, G. W. Ewing, McGraw Hill Book Co, NY.

4. Instrumental Methods of Chemical Analysis, B.K. Sharma, Goel Publication House,

Meerut, India.

5. United States Pharmacopoeia, United State of Pharmacopeias convention, INC, 12601

Twin brook Parkway, Rockville, MD 20852.

6. British Pharmacopoeia, 2004, The British Pharmacopoeia commission office, Market

Tower, Nine Elms Lane, London.

7. Indian Pharmacopoeia-2010, Indian pharmacopoeia commission, Sector-23, Raj Nagar,

Ghaziabad.

8. Remington’s Pharmaceutical Sciences, J. P. Remington, Mack Pub. Co., Pennsylvania.

9. Modern Methods of Pharmaceutical Analysis, Vol 1, 2, RE Schirmer, Franklin Book Co, PA.

10. Spectroscopic identification of organic compounds. R.M. Silverstein, G.C. Bassler, T.C.

Morrill, Pub: John Wiley and Sons, NY.

12. Spectroscopic identification of organic compounds. John Dyer, Willy, NY.

13. Organic Spectroscopy W. Kemp, NY.

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14. NMR spectroscopy (Basic Principles, concepts and application in Chemistry) Herald

Gunther, (John Wiley and Sons), NY.

15. Pharmaceutical Analysis – Modern Methods – Part A, Part B, J. W. Munson, Marcel

Dekker, NY.

16. Practical Pharmaceutical Chemistry, Part two, edited by A. H. Beckett & J. B. Stenlake

17. Identification of Drugs and Pharmaceutical Formulations by Thin Layer Chromatography,

P. D. Sethi, CBS Publishers and Distributers, New Delhi.

18. HPTLC – Quantitative Analysis of Pharmaceutical Formulations – P. D. Sethi, CBS

Publishers and Distributers, New Delhi.

19. Stereo Chemistry – Conformation and Mechanism by P. S. Kalsi, New Age International

Publishers.

20. Chromatographic Analysis of Pharmaceuticals, A. John, Adamovics, Cytogan Corporation,

Princeton, NJ.

21. Clerk’s analysis of Drugs and Poisons, A.C. Moffet, M. D. Osselton, B. Widdop L. Y.

Galichet, Pharmaceutical Press.

22. Relevant articles from journals.

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SEMESTER-I QUALITY ASSURANCE, GOOD MANUFACTURING PRACTICES AND

GOOD LABORATORY PRACTICES (PH816.02)

Credits: 5 Theory + Seminar Contact Hours Per week: 5 Theory + Seminar


To make students familiar with the principles of Quality Assurance, Good Manufactruing

Practices and Good Laboratory Practices and its application in pharmaceutical industry.

Student Learning Outcomes/Objectives:

At the end of the course, the student will be able to understand the fundamental concept of

quality control and quality assurance, which is important to maintain the quality and safety of

pharmaceutical products.

Instructional Methods and Pedagogy:

Faculty member/s shall explain in a class room using black board and multimedia projector.

Outline of the Course:

Sr. no. Unit

Minimum Number of

Contact Hours

Approx % Weightage

1 Basic Concepts of Quality Assurance 3 5 2 Quality Control 7 10 3 Good Manufacturing Practices (Schedule M) 15 26 4 Good Laboratory Practices 10 20 5 Inspections and Quality Audit 9 16 6 Stability Aspects 7 10 7 Process Analytical Technology 4 6 8 Quality by design 5 7

Total 60 100%

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1. Basic Concepts: 3

Quality concepts, Quality Control, Quality Assurance, Good Manufacturing Practices, Good Laboratory Practices, Responsibilities.

2. Quality Control: 7 Quality control laboratory: Responsibilities, good laboratory practices, routine controls, instruments, protocols, non-clinical testing, controls on animal house, data generation and storage, quality control documents, retention samples, records, audits of quality control facilities.

3. Good Manufacturing Practice (Schedule M) 15

a) Concepts GMP and cGMP. b) Legal requirements pertaining to GMP: GMP Guidelines,

Standards, Regulatory agencies c) Basic Components of GMP: Organization & Personnel,

Premises, Equipments, Raw Materials, Control on Manufacturing of dosage forms, Packaging

and labeling control, Laboratory controls, Finished product release, Warehousing, Distribution

and distribution records, waste and scrap disposal, Complaints and recalls, Specifications, Self

inspection. d) GMP for ayurvedic formulations (Sch. T of D & C act)

4. Good Laboratory Practice (GLP): 10

a) GLP – an overview and basic information, Scope. b) Principles of GLP: Test Facility Organization and Personnel, Quality Assurance Programme, Facilities, Apparatus, Material, and Reagents, Test Systems, Test and Reference Items, Standard Operating Procedures, Performance of the Study, Reporting of Study Result, Storage and Retention of Records and Materials. c) Responsibilities in GLP d) Implementing of GLP in non GLP analytical laboratory

5. Inspections, Quality Audit and Quality System Reviews: 9

Inspections of pharmaceutical manufacturers, role of quality audit, role of inspectors, methods of

inspection- routine, concise, follow-up and special inspections, frequency and duration of

inspections, preparations for inspections, conduct, report and regulatory actions. Loan License

Auditing – Concepts, Auditing, role of quality circle in quality assurance

6. Stability Aspects: 7

Basic concept and objectives of stability study, Kinetic principles applied for stability

evaluation and their applications in predicting shelf life and half-life of pharmaceutical

formulations, Importance of accelerated stability study.

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7. Process Analytical Technology (PAT)

Basic concepts and regulatory aspects 4

8. Quality by design 5

Introduction, Regulatory considerations, Characteristics of QBD programme, Defining

product requirements and CQAs, Role of QRM in QBD, Design space and Control strategy.

Recommended Study materials:

1. Pharmaceutical facilities, design, layouts and validation, Manohar A. Potdar, PharmaMed Press, Hyderabad.

2. Quality Assurance in Analytical Chemistry, B.W,Wenclawaik, M.Koch, E.Hadjicosta, Springer.

3. Remington: The Science and Practice of Pharmacy, Vol-I & II, Gennaro, Alfonso R., 4. Lippincott Williams & Wilkins, New York. 5. Good Laboratory Practice Regulations, Weinberg, Informa Healthcare. 6. Guidelines on cGMP and Quality of Pharmaceutical Products, S.Iyer, D.K.Publications,

Mumbai. 7. Quality Control of Packing Materials in Pharmaceutical Industry, Kenneth, Harburn, Marcel

Dekker, New York. 8. Quality in the Analytical Chemistry Laboratory, Elizabeth Prichard,Wiley, India, 9. WHO GMP guidelines 10. OECD Series on Principles of Good Laboratory Practice (GLP) (http://www.oecd.org) 11. FDA GMP guidelines 12. US-FDA PAT guidelines 13. ICH Quality Guidelines 14. Drug and Cosmetics Act.

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SEMESTER-I PHARMACEUTICAL ANALYSIS - I (PH816.03)

Credits: 5 Theory+ Seminar Contact Hours Per week: 5: Theory + Seminar


To make students familiar with the scope and applications of Pharmaceutical Analysis.

Student Learning Outcomes/Objectives: At the end of the course, the student will be able to learn the basic fundamentals of

Pharmaceutical Analysis and its multidisciplinary aspects. The students will also learn the

applications of Pharmaceutical Analysis in various fields. Instructional Methods and Pedagogy:


It also includes presentation by a students on a specific topic assigned to them by the faculty. Outline of the Course:

Sr. No. Unit

Minimum

No. of

Contact

Hours

Approx.

Weightage

%

1 Fundamentals of Pharmaceutical Analysis 3 5 2 Pharmacopoeial Methods of Analysis 12 20 3 Calibration of Analytical Instruments 8 11 4 Physicochemical Methods of analysis 5 10 5 Analytical Method Development 8 12 6 Analytical Method Validation 6 10 7 Computer aided analysis, LIMS 4 8 8 Cosmetic Analysis 6 10 9 Food analysis 8 14

Total 60 100%

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1. Fundamentals of Pharmaceutical analysis 3

Introduction to pharmaceutical analysis and techniques, multidisciplinary aspect of pharmaceutical analysis, Good laboratory practice to be followed in pharmaceutical analysis labs, introduction to reference standards, reagents and glassware, apparatus

2. Pharmacopoeial Methods of Analysis 12

Overview of different pharmacopeias (IP, BP, USP, EP, JP), comparative study on monographs of API and finished products as per all pharmacopeias

Principle of various biological, chemical, physical methods described in IP.

Pharmacopoeial tests for different formulations like capsules, creams, ear drops, eye drops, eye ointment, gels, inhalation preparation, nasal preparation, ointments, oral liquids, oral powders, parenterals, pessaries, suppositories, tablets.

A detailed study of the various principles and procedure involved in the quantitative analysis of pharmaceutical preparations and dosage forms containing the following groups of drugs included in I.P (a) Analgesics and Antipyretics (b) Sedatives & Tranquillizers (c) Antihypertensives (d) Antibiotics & Antibacterials (e) Cardiovascular drugs (f) Vitamins(g) Antihistaminics (h) Antidiabetics

3. Calibration of Analytical instruments 8

Importance of calibration, frequency of calibration, difference between validation and calibration, calibration of various analytical instruments like pH meter, conductometer, potentiometer, HPLC, HPTLC, UV-visible, Spectroflourimeter, dissolution apparatus, disintegration test apparatus, friability tester, digital weight balance, IR spectrometer, Melting point apparatus, DSC, TGA 4. Physicochemical Methods of Analysis 5 Principle of physicochemical methods described in IP. Study of physicochemical aspects: a. pKa b. Partition Coefficient c. Solubility d. Solid state characterization and physical behavior of drugs. e. Reaction kinetics and mechanisms. Biological aspects: a. Role of physicochemical parameters on drug absorption and their implications. b. Routes of administrations and implications on bioavailability. 5. Analytical Method Development 8 Introduction, compatibility with the instrumental method, fundamental theories of solubility and other physicochemical properties, sample preparation, method development process, selection of critical steps and their optimization, use of Experimental designs, QBD approach.

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Steps involved in development of analytical methods for assay of API and finished products, dissolution methods, stability indicating methods

6. Analytical Method Validation 6

Need of analytical method validation, Validation parameters: definition, methodology and acceptance criteria, Statistical considerations in Analytical method validation and application of experimental designs, Comparative study of guidelines as per ICH, FDA, WHO, USP.

7. Computer-aided analysis, LIMS 4

Introduction to techniques, role in pharmaceutical industry, Significance and importance, processing of chromatographic data.

8. Cosmetic Analysis 6 Various types of raw materials used in the cosmetic industry for the manufacture of finished products, General methods of analysis to determine the quality of raw materials used in cosmetic industry, Methods of analysis to determine the quality of cosmetics in the finished forms such as Hair care products, Skin care products, Baby care products, Dental products, Personal hygiene products, makeup preparation, Lipsticks, Hair setting lotions and Eye shadows. Toxicity testing in cosmetics and Safety and Legislation of Cosmetic products. 9. Food Analysis 8 Legislation (Food safety and standards act 2006), standards and nutrition, general chemical and instrumental methods, contaminants, additives, analysis of sugars, preservatives, starch products, beverages, chocolates, herbs, spices, cereals, oils and fats, dairy products, Microbiological testing for food quality, pesticides analysis in food products


1. Principles of Instrumental Analysis, Skoog, Hollar and Nieman, Saunders College Publishers,

Philadelphia.


Distributers, Delhi.


4. Instrumental Methods of Chemical Analysis, B.K. Sharma, Goel Publication House, Meerut,

India.

5. John H. Kennedy, Principles of Analytical Chemistry, 2nd Edition, Saunders College

Publishing, New York.

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6. Higuchi, Bechmman and Hassan : Pharmaceutical Analysis, John Wiley and Sons, New York.

7. D. C. Garratt, The Quantitative Analysis of Drugs, CBS Publishers, New Delhi.

8. P. D. Sethi, Quantitative Analysis of Drugs in Pharmaceutical Formulation, CRC press

9. J. W. Munson, Pharmaceutical Analysis – Modern Methods, Part – A & B, 2001.

10. United States Pharmacopoeia, United State of Pharmacopeal convention

11. British Pharmacopoeia, 2010, The British Pharmacopoeia commission office

12. Indian Pharmacopoeia-2007, Indian pharmacopoeia commission

13. ICH Q2 R1: Validation of analytical procedures: text and methodology, EMEA, June 25

16. FDA guidelines For Validation of analytical Method

17. WHO guidelines For Validation of analytical Method

18. How to perform GMP, P P Sharma, Vandana Publications, New Delhi

19. Handbook of cosmetics: Formulation, Manufacturing and quality control, by PP sharma,

Vandana Publications, New Delhi

20. Pearson’s Composition and analysis of foods, R.S.Kirk, R. sawyer, Addson Weskey, England

21. Handbook of Forensic analysis, Fedrick P, Academic Press

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SEMESTER-I CLINICAL RESEARCH AND DRUG REGULATORY AFFAIRS (PH816.04)

Credits: 4: Theory Contact hrs per week: 4: Theory

Objectives of the course:

- To explore the regulatory provisions with respect to clinical trials, Investigational New

Drug Application, New Drug Application, ANDA, market authorization of medicines,

inspection of Pharmaceutical manufactures and product registration.

- To explore practical aspects repeated to patenting

Students learning outcomes/objectives:

- To get familiar with regulatory aspects related to Research & Development as well as

manufacturing and marketing of Pharmaceutical Products

- To get familiar with ICH guidelines with respect to Quality topics.


- The course employs lectures and class discussions. It also includes presentation by

students on a specific topic assigned to them by the faculty

Outline of the course:

No. Unit Minimum no. of Contact Hours.

Aprrox. Weightage %

Part – I: Clinical Research

1 Basics concepts of clinical trials 8 14

2 Regulatory aspects related to clinical trials 8 13

Part – II: Drug Regulatory Affairs

3 Approval Process 9 15

4 MHRA guideline for Market authorization of medicines 3 5

5 WHO guidelines for inspection of pharmaceutical Manufacturers

3 5

6 Requirements of product registration in Regulated, semi regulated and non-regulated countries.

5 8

7 DMF and dossier in CTD format. 6 10

8 API regulatory submissions 5 8

9 Medical devices regulations 3 5

10 ICH Guidelines 10 17

Total 60 100

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1. Basic concepts of clinical trials: 8

Introduction to clinical drug development process, Study designs, Ethical considerations,

Inclusion and Exclusion criteria’s, Termination criteria, Data Interpretation, Management,

Review and Approval process for Clinical Study, Clinical research protocol, brief overview

of Clinical pharmacokinetics, BA-BE studies and Drug safety in clinical trials.

2. Regulatory aspects related to clinical trials: 8

As per Schedule Y of Drugs and Cosmetics Act 1940 and rules and ICH GCP.

Quality assurance in Clinical research

3. Approval Process: 9

Detailed study of Federal Food, Drug and Cosmetics Act of USA restricted to human

drugs, cosmetics and biotechnology products, with special emphasis on: General drug

approval process, Investigation New Drug (IND) Application, New Drug Application

(NDA) and BLA, Abbreviated New Drug Application (ANDA), SNDA, BACPAC and

SUPAC (Immediate release solid oral dosage form) and Post marketing surveillances.

4. MHRA guideline: for Market authorization of medicines. 3

5. WHO guidelines for inspection of pharmaceutical Manufacturers. 3

6. Requirements of product registration in Regulated, semi regulated and nonregulated

countries. 5

7. DMF and dossier in CTD format. 6

8. API regulatory submissions to USFDA/EMEA. 5

9. Regulatory requirements for medical devices. 3

10. ICH Guidelines: Introduction to ICH guidelines- Safety, Quality, Efficacy and

Miscellaneous. Overview to the Quality guidelines: Q1 A, Q1 B, Q2, Q3, Q5C, Q7, Q8, Q9

and Q10. 10


1. www.usfda.gov

2. www.mhra.gov.uk

3. www.ich.org/cache/compo/363-272-1.html

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4. apps.who.int/prequal/info_general/documents/TRS823/WHO_TRS_823-Annex2.pdf

5. FDA regulatory Affairs, edited by D. J. Pisano and D. Mantus, CRS Press, Boca

Rocan,Florida.

6. New Drug Approval process, 4th Edition, R.A.Guarino, Marcel Dekker, New York.


8. SUPAC guidelines

9. ICH GCP guidelines

10. Schedule Y of Drugs and Cosmetics act

11. http://www.icpc.biz/downloads/Sampledossier.pdf

12. www.Ich.org/ectd

13. Textbook on clinical research:A guide for Aspiring professionals and Professionals,

Guru Prasad Mohanta, Pharma med press.

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SEMESTER-I PRACTICAL-I (Modern analytical Techniques and Biostatistics) (PH816.05)

Credits: 3 Practical Contact hrs per week: 6: Practical


• To have hands on training on statistical tools and routinely used analytical instruments.

Student Learning Outcomes / objectives:

• To get familiar with the most routine statistical tools in field of analysis

• To have practical exposure to the basic instrumental techniques in Pharmaceutical

analysis for checking assay and quality of formulations.

Instructional Method and Pedagogy:

• Experiments to be performed in laboratory and computer labs. Outline of the course:

Sr

No.

Title of the unit Minimum

number of

hours

Approx.

Weightage

%

1. Biostatistics 45 50

2. Analytical techniques 45 50

Total 90 100%

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Detailed Syllabus (Practical):

Unit I: Biostatistics

A. Introduction to statistical software in pharmaceutical analysis

B. Interpretation of pharmaceutical experimental data using statistical concepts and to perform data analysis using statistical software for the following:

1. Study of control charts for monitoring different manufacturing process.

2. Process validation of pharmaceuticals.

3. Calculation of Average, std deviation, Standard error of mean, relative std deviation.

4. Perform Z test, Chi square test, t-test(paired and unpaired) for given data.

5. Plot calibration curve for drug analysis (linearity studies) and study different parameters for linear regression analysis.

6. Correlation analysis and its applications in pharmacy

7. Calculation of Area under curve by various methods.

8. Generation of 3D and response surface plots.

9. Study of 1-way and 2-way ANOVA and its applications to pharmaceutical data.

C. Study of software like pKa database, log P database, Chem office and chem draw etc.

Unit II: Analytical techniques

1. To perform assay of APIs using Calibration curve method UV, HPLC, HPTLC, Spectrofluorimetry. (4 practicals)

2. To study effect of solvent on UV spectra on any API

3. To determine isosbestic point and pKa value of any compound using UV

4. To perform assay of any combined dosage form using different types of UV methods like Simultaneous equation, derivative, differential, area under curve, Q ratio and dual wavelength methods. (4 practicals)

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Recommended study materials:

1. Stanford Bolton, Charles Bon (2004), Pharmaceutical Statistics, Practical and Clinical

Applications (Fourth rev. ed) Marcel Dekker, Inc

2. Dowdy, S., and Wearden, S. (1991), Statistics for Research (2nd ed.), New York: John Wiley.

3. Freund, R. J., and Wilson, W. J. (1997), Statistical Methods (rev. ed.), San Diego, CA:

Academic Press

4. Miller, R. G., Efron, B., Brown, B. W., and Moses, L. E. (eds.) (1980), Biostatistics Casebook,

New York: John Wiley.

5. Steel, R. G. D., and Torrie, J. H. (1980), Principles and Procedures of Statistics: A Biometrical

Approach (2nd ed.), New York: McGraw-Hill.

6. Woolson, R. F. (1987), Statistical Methods for the Analysis of Biomedical Data, New York:

John Wiley.

7. Wackerly DD, Mendenhall W, Scheaffer RL. Mathematical Statistics with Applications, 7th

edition, 2008, Duxbury Press, USA

8. Piantadosi S. Clinical Trials a Methodological Perspective, 2nd edition. John Wiley & Sons

2005

9. Senn S. Cross-over trials in clinical research, 2nd edition. Wiley, 2002.

10. Jennison C. and B.W. Turnbull. Group sequential methods with applications to clinical

trials. Chapman & Hall, 1999.


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SEMESTER-I

Practical-II (Pharmacopoeial methods of Analysis) (PH816.06)



• To get acquainted with aspects of method development and principles behind it and have hands on training on sophisticated analytical instruments.


• To get familiar with the principles and fundamentals of method development

• To have practical exposure to the instrumental techniques in Pharmaceutical analysis

for checking assay and quality of formulations.


• Experiments to be performed in laboratory and Sophisticated Instrument lab. Outline of the course:

Sr

No.


number of hours

Approx.

Weightage

%

1. To perform Pharmacopoeial tests for API and finished products

12 15

2. Calibration of various analytical instruments 18 20

3. Study of physicochemical properties 6 10

4. Solid state analysis of drug substances 12 15

5. Protocol for analytical method development and validation

12 10

6. Analysis of cosmetic products 12 15

7. Analysis of food products 12 10

8. Analysis of Pharmaceutical formulation containing different class of drugs

6 5

Total 90 100%

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Detailed Syllabus (Practical)

1. To perform Pharmacopoeial tests of APIs

2. To perform Pharmacopoeial tests of Finished Products

3. Calibration of various analytical instruments like pH meter, conductometer, potentiometer, HPLC, HPTLC, UV-visible, Spectroflourimeter, dissolution apparatus and IR Spectrophotometer

4. Physicochemical analysis (pKa, solubility, partition coefficient) of drug substances

5. Solid state analysis of drug substances

6. To develop a protocols for Analytical method development for estimation of Combination drugs from Formulations.

7. To develop analytical method validation Protocols for estimation of Combination drugs from Formulations.

8. Analysis of various marketed cosmetic products and Pharmacopoeial products (creams, gels etc) using different instrumental techniques.

9. Analysis of milk, biscuits and other food products using different instrumental and non instrumental techniques

10. Analysis of Pharmaceutical formulation containing different class of drugs: Sulphonamides, Vitamins, Antibiotics etc. using instrumental or non-instrumental techniques Recommended Study materials:

1. Principles of Instrumental Analysis, Skoog, Hollar and Nieman, Saunders College Publishers,

Philadelphia.


Distributers, Delhi.


4. Instrumental Methods of Chemical Analysis, B.K. Sharma, Goel Publication House, Meerut,

India.

5. John H. Kennedy, Principles of Analytical Chemistry, 2nd Edition, Saunders College

Publishing, New York.

6. Higuchi, Bechmman and Hassan : Pharmaceutical Analysis, John Wiley and Sons, New York.

7. D. C. Garratt, The Quantitative Analysis of Drugs, CBS Publishers, New Delhi.

8. P. D. Sethi, Quantitative Analysis of Drugs in Pharmaceutical Formulation, CRC press

9. J. W. Munson, Pharmaceutical Analysis – Modern Methods, Part – A & B, 2001.

10. United States Pharmacopoeia, United State of Pharmacopeal convention

11. British Pharmacopoeia, 2010, The British Pharmacopoeia commission office

12. Indian Pharmacopoeia-2007, Indian pharmacopoeia commission

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13. ICH Q2 R1: Validation of analytical procedures: text and methodology, EMEA, June 25

16. FDA guidelines For Validation of analytical Method

17. WHO guidelines For Validation of analytical Method

18. How to perform GMP, P P Sharma, Vandana Publications, New Delhi

19. Handbook of cosmetics: Formulation, Manufacturing and quality control, by PP sharma,

Vandana Publications, New Delhi

20. Pearson’s Composition and analysis of foods, R.S.Kirk, R. sawyer, Addson Weskey, England

21. Handbook of Forensic analysis, Fedrick P, Academic Press

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SEMESTER-I Scientific Communication (PH824.01)

(Practical) Credits: 1 (Practical) Contact Hours per week: 3 (Practical)


To enhance the scientific communication skills of students

Student Learning Outcomes / Objectives:

The students are expected to strengthen their communication skills in scientific writing as well

presentations.


The faculty shall stress on the importance of the concept of the specific type of module of

communication and explain using examples. The students may be assigned individual exercise

and they will be counseled personally, keeping in mind the aspects of plagiarism.

Outline of the Course (Practical):

No. Unit Practical hours per

week 1. Development of Scientific Writing Skills

3 .00 2. Development of Presentation Skills

Total 45 hours/

semester

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Detailed syllabus (Practical):

No. Unit Scientific Writing Skills

1 Review of Instruction for Authors of a Journal / Periodical - I

2 Report writing for publication in various formats

3 Preparation of Manuscript for publication to a Journal / Periodical - I

4 Writing in Laboratory Notebook on Experiment Carried Out

5 So P Preparation

Comprehension of Scientific writing

6 Review and Analysis of Review / Research Article - I

7 Review and Analysis of Review / Research Article - II

Presentation of Scientific Matter

8 Poster Presentation

9 Oral (Podium) Presentation - I

10 Oral (Podium) Presentation - II

11 Verification of plagiarism using softwares

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SEMESTER-I

COMMUNITY SERVICES-I (PH824.02)

(PRACTICAL)

Credits: 1 Contact hrs per week: 3

Course Description

• Students are undertaking a group research project. Students of each group choosing community service projects must commit at least 3 hours/week to their projects.

• Students in this course will have an opportunity to work collaboratively with community partners to identify needs in communities.

• Students will investigate, discuss, and plan methods of addressing identified needs within the community.

• Under the guidance of the instructor or an advisor, students will be actively involved in implementing a self-designed community service project.

Course Goals

• Promote active learning and responsible citizenship.

• Identify personal values, beliefs, attitudes, and philosophies.

• Promote collaborative learning.

• Strengthen ties between student and community; and community and college.

• Foster a commitment of service to others. Course Objectives

• Develop interpersonal skills necessary for being an active participant in a community

• Develop a learning community

• Investigate and identify needs within a community

• Develop a plan of action for responding to an identified need of the community Course Evaluation

Students choosing to do projects are expected to demonstrate that they have expended at 45

hours on their projects.

The performance of every student will be evaluated as follows:

Approx. Weightage (%) Project Proposal 50 Midterm & Final report (assignment) 50

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SYLLABI (Semester–2)


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SEMESTER-II

RESEARCH METHODOLOGY & IPR (PH824.03)

Credits: 4 Theory Contact hrs per week: 4 Theory


• To make students familiar with various established methods used in pharmaceutical research.

• To explore practical aspects related to patenting. Student Learning Outcomes/Objectives:

• At the end of the course, the student will be able to understand the hierarchy of continue research by proper fundamental methodology.

• The students will get familiar with IPR and Patents.


• Faculty member/s shall explain and discuss the case studies in a class room using black board and multimedia projector.


Sr. No.

Unit Minimum No.

of Contact Hours

Approx. Weightage %

1 Research 4 7

2 Research problem formulation 5 8

3 Methods and tools used in research 5 8

4 Documentation 4 7

5 The Research Report writing, Paper writing/ thesis writing

10 16

6 Presentation 5 8

7 Cost analysis of the project 3 4

8 Sources for procurement of research grants 4 7

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Part – II : Intellectual Property Rights (IPR)

1 Intellectual Property Concepts 5 9

2 IPR and Pharmaceutical Research 3 4

3 Practical aspect of patenting 7 13

4 IPR related treaties 2 4

5 Case Study 3 5

Total 60 100%

Detailed Syllabus:

Part-I Research Methodology (40 hours)

1 Research:

Meaning, purpose, Types, (Educational, Clinical, Experimental, historical descriptive, Basic

applied and Patent oriented Research) objective of research.

2 Research Problem Formulation: Literature Survey: purpose and use of literature review, locating relevant information, use of library and electronic databases. Preparation and presentation of literature review, research and review articles, theoretical models and framework, selecting problem and preparing research proposal.

3 Methods and tools used in research:

• Qualitative studies, quantitative studies

• Simple data organization, descriptive data analysis

• Limitation & sources of Error

• Inquiries in form of Questionnaire, etc. 4 Documentation:

“How” of documentation Techniques of documentation Importance of documentation Use of computer packages in documentation. 5 The Research Report writing, Paper writing/ thesis writing:

Different parts of the Research paper

• Title , Authors Name & contact details

• Abstract- statement of the problem, background and purpose and scope of research.

• Key Words

• Subject Area

• Methodology: apparatus, instrumentation & procedure.

• Results- tables, graphs, figures & statistical presentation

• Discussion : support or non support of hypothesis, practical & theoretical Implications

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• Conclusion

• Acknowledgements.

• References

• Errata

• Importance of Spell check for entire research paper

• Uses of footnotes 6 Presentation (especially for oral presentation):

Importance, types different skills, content, format of model, gestures, eye contact, facial

expressions, stage-fright, volume- pitch, speed, pause & language, Visual aids &

Questionnaire.

7 Cost analysis of the project: Cost incurred on raw materials, different testing procedures for the same parameter, cost of instrument utilization & cost of the clinical trials.

8 Sources for procurement of research grants: International agencies, Government and private bodies, Industrial projects and their feasibility reports

Part-II IPR (20 Hours)

1. Intellectual Property Concepts: • Concept of property, conventional property Vs Intellectual Property

• Basic aspect of the 8 different IPR mechanism Viz. Patents, Copyright, trademark, industrial design, layout design of integrated circuits, geographical indicators, plant varieties & trade secrets.

2. IPR and Pharmaceutical Research: • Benefits of IPRs to improve the quality of research work

• Strategies for avoiding research duplications, infringements 3. Practical aspect of patenting:

• Indian patent act and its recent amendment with respect to following aspect o Patentable and non-patentable inventions. o Essential criteria for filing a patent. o Filling a patent in India and abroad o Drafting of patent application

• Patenting: Regional routes & national routes.

• Introduction to World Intellectual Property Organization. (WIPO)

• Commercialization of patent: Need for Commercialization of research and role of IPRs in research Commercialization.

• Benefit/Disadvantages of patenting to the society 4. IPR related treaties:

1. Patent co-operative treaty 2. Budapest treaty

5. Case Study

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1. Research In Education- John V. Best, John V. Kahn 7th edition, Published by: Phi Learning Pvt. Ltd

2. Presentation skills - Michael Hallon- Indian Society for Institute education

3. Practical Introduction to copyright.- Gavin McFarlane, Published By: Mcgraw-Hill Inc, USA.

4. Thesis projects in Science & Engineering – Richard M. Davis. New York: St. Martin’s Press, 1980.

5. A review of “Scientist in legal Systems”, Journal of Forensic Sciences (JOFS),21(2),1976. 6. Thesis & Assignment – Jonathan Anderson by John Wiley & Sons Inc. USA (1998). 7. Donald Menzel, Jones, Howard Mumford; Boyd, Lyle G., Writing a technical paper, J.

Chem. Edu., 1962, 39 (6), p A500 8. Effective Business Report Writing –Leland Brown, 2nd Edition, Prentice-Hall, Englewood

Cliffs, New Jersey, 1963. 9. Protection of industrial Property rights- P. Das & Gokul Das. 10. Preparing for publication: A Style Book for Authors, Editors, Compilers and Typists – King

Edward Hospital Fund for London. 11. The Hindu speaks on Information Technology (Special Publication by The Hindu) 12. Manual for evaluation of industrial projects-(Prepared Jointly by United Nations Industrial

Development Organization and the Industrial Development Center for Arab States). 13. Manual for the preparation of industrial feasibility studies (Newly rev. and expanded ed. W.

Behrens, P.M. Hawranek, Published by United Nations Industrial Development Organization in Vienna .1991.

14. Stanford Bolton, Charles Bon (2004), Pharmaceutical Statistics, Practical and Clinical Applications (Fourth rev. ed) Marcel Dekker, Inc

15. Relevant articles from journals 16. IPR Handbook for Pharma Students and Researchers, Parikshit Bansal, Pharma Book

Syndicate, Hyderabad. 17. Patents, N. R. Subbaram, Pharma Book Syndicate, Hyderabad. 18. Relevant articles from journals. 19. www.pat2pdf.org 20. www.patentstorm.us 21. www.freepatentsonline.com 22. http://www.wipo.int/pctdb/en/ 23. www.espacenet.com

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SEMESTER-II PHARMACEUTICAL VALIDATION AND DOCUMENTATION (PH816.07)

Credits: 5 Theory + Seminar Contact Hours Per week: 5 Theory + Seminar


To make students familiar with the principles of Process Validation and Documentation and its

application in pharmacy.



Process Validation and Documentation, which is important to maintain the quality of

pharmaceutical products and meet the regulatory guidelines.




Sr no. Unit

Minimum Number of

Contact Hours

Approx % weightage

1 Process Validation 33 55

2 Pharmaceutical Documentation 27 45

Total 60 100%


1. Process Validation 33

a. Introduction to Pharmaceutical Process Validation: Definition, scope of Validation, Advantage of

Validation, Organization for Validation, Validation Master Plan, Types of process validation,

Qualification of facilities.

b. Validation of Equipment: Concept of User Requirements Specification, DQ, IQ, OQ & PQ,

Validation of following equipment: Dry Powder Mixers, Fluid Bed and Tray dryers, Tablet

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Compression Machine, Dry Heat Sterilization/Tunnels, Autoclaves, Membrane filtration, Capsule

filling machines.

c. Vendor Certification.

d. Utilities Validation: Validation of Pharmaceutical Water System, Water for Injection & pure

steam, Validation of HVAC system, Validation of Gases.

e. Cleaning Validation: Cleaning of Equipment and facilities, Cleaning Validation Master Plan,

elements of cleaning, Validation Protocol, Acceptable limits.

f. Computer System Validation.

2. Documentation 27

a. Good Documentation Practices in Pharmaceutical Industry. b. Documentation related to pharmaceutical industry:

i) Manufacturing documents: Batch manufacturing record, Batch formula record, Master Formula Record. ii) Quality Assurance Documents: Validation protocols, Validation master plan, Analytical method validation protocols, Validation reports: IQ, OQ, PQ protocols, SOP, Audit Records, Security Records. iii) Testing Documents: Certificate of Analysis, IPQC protocols, Test method protocol, finished product and raw material protocol, Stability studies protocol iv) Maintenance and Environmental Control related documents. v) Store Management Records: Store reconciliation records for raw material, finished products and Packaging materials. vi) Consumer Related Documents: Product recall, complaint traceability, printing packing.

c. Documentation control: Revision and approval of new documents, numbering system, archiving of documents. d. Brief introduction to paperless documentation system


1. Quality Assurance in Analytical Chemistry, B.W,Wenclawaik, M.Koch, E.Hadjicosta,

Springer.

2. Pharmaceutical Validation Master Plan, Syed Imtiaz Haider, Informa Healthcare, U.K.

3. Pharmaceutical Process Validation, Robert A. Nash, Alfred H. Wachter, Informa

Healthcare.

4. Guidelines on cGMP and Quality of Pharmaceutical Products, S.Iyer, D.K.Publications,

Mumbai.

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5. Validaion and Qualifications in Analytical Laboratories, Ludwig Huber, 2nd Edition,

Informa Healthcare.

6. Validation in Pharmaceutical Industry, Concepts Approaches and Guidelines, P.P.Sharma, Vandana Publications, Pvt. Ltd., Delhi.

7. Validation of Pharmceutical Process, Sterile products, F.J.Carleton, J.PAgallo, Marcel Dekker New York.

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SEMESTER-II

PHARMACEUTICAL ANALYSIS-II (PH816.08)

Credits: 5 Theory +seminar Contact Hours Per week: 5: Theory+seminar


To make students familiar with the scope and applications of Pharmaceutical Analysis.

Student Learning Outcomes/Objectives: At the end of the course, the student will be able to learn the basic fundamentals of

Pharmaceutical Analysis and its multidisciplinary aspects. The students will also learn the

applications of Pharmaceutical Analysis in various fields.




Sr.

No. Unit

Minimum No.

of Contact

Hours

Approx.

Weightage

%

1 Bioanalytical method development and validation

6 10

2 Analysis of drugs from biological fluids 6 10

3 Analysis of biotechnology derived products 6 10

4 Bioavailability and Bioequivalence studies 3 4

5 Forensic analysis 3 5

6 Dissolution and diffusion studies 3 6

7 Impurity Profiling 12 20

8 Spectral Analysis 15 25

9 Phytochemical Analysis 6 10

Total 60 100 %

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1. Bioanalytical method development and Validation 6

Importance of Bioanalytical method development, Sample preparation techniques, Critical

optimization steps for method development.

Industrial and EMEA guidelines for BMV, Steps involved in BMV

Differentiating steps from Analytical Method Validation

2. Analysis of drugs from biological fluids 6

Importance, Special Problems with Biological Fluids, Need for and background of analysis of

drugs in biological fluids, Problems encountered in testing biological specimens, Extraction

procedures for drugs and metabolites from biological samples LLE, SPE, Precipitation etc.

Factors affecting extraction of drugs. Case studies of drug analysis from bio fluids

3. Analysis of proteins and biotechnology derived products 6

Scope of biotechnology in development of Pharmacopoeial articles, analytical methods for

biotech derived products like amino acid analysis, protein sequencing, peptide mapping,

immunoassays, electrophoresis, quantitative assays, Stability of biotech products, case studies

for different proteins and biotech products, microbial limit tests, microbial assays, BET, sterility

testing

4. Bioavailability and Bioequivalence studies 3

Guidelines for BA-BE studies, requirements for NDA and ANDA, IVIVC

Experimental designs for the study

5. Forensic Analysis 3

Techniques used and interpretation of results, collection of forensic sample, preservation of

sample and report filing for evidence analysis, Forensic drug analysis of commonly abused drugs

from their pharmaceuticals and biological fluids

6. Dissolution and Diffusion studies 3

Theories of diffusion and dissolution, Release rates, Compendial requirements, Dissolution method development, dissolution data handling and correction factors

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7. Impurity Profiling 12

Types of impurities, Impurities in drug products, regulatory guidance, forced degradation

studies, Isolation and Characterization of Impurities, Residual solvents and water, Case studies

with relevant examples

Metabolite identification in drug discovery

8. Spectral Analysis 15

Ultra violet and visible spectroscopy: Energy levels and selection rules, Woodward-Fieser and

Fieser-Kuhn rules. Influence of substituent, ring size and strain on spectral characteristics;

Solvent effect; Stereochemical effect; Non-conjugated interactions; Spectral correlation with

structure.

Infrared spectroscopy (IR): Characteristic regions of the spectrum. Influence of substituents,

ring size, hydrogen bonding, vibrational coupling and field effect on frequency. Spectral

interpretation with examples.

Nuclear magnetic resonance spectrometry (NMR): chemical shift and shielding, relaxation

processes, local diamagnetic shielding and magnetic anisotropy, spin-spin splitting, Pascal’s

triangle, coupling constant, mechanism of coupling

Mass spectrometry (MS): Molecular ion and metastable peak, fragmentation patterns, nitrogen

and ring rules, McLafferty rearrangement, electron and chemical ionization modes, applications.

Structure elucidation of pharmaceutical compounds using different spectroscopic techniques

like UV-Visible, IR, NMR, Mass etc

9. Phytochemical Analysis 6

Methods of systematic phytochemical analysis including extraction and identification of plant

constituents using chromatographic techniques. Detection of common adulterants and insects

infestation in whole and powdered drugs. WHO guidelines for the quality control of raw

materials used in herbal formulations. Stability testing of phytopharmaceuticals

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2. The Analysis of Drugs in Biological Fluids, Joseph Chamberlain, CRC Press

3. EMEA for Bioanalytical method validation

4. Industrial guidelines for Bioanalytical method validation

5. BA-BE guidelines for BA-BE studies as per USFDA (CFR)

6. Spectroscopic identification of organic compounds. R.M. Silverstein, G.C. Bassler, T.C.

Morrill, Pub: John Wiley and Sons, NY.





10. Introduction to Spectroscopy, Pavia, Lapmann, Springer

11. Identification of Drugs and Pharmaceutical Formulations by Thin Layer

Chromatography, P. D. Sethi, CBS Publishers and Distributers, New Delhi.



13. Stereo Chemistry – Conformation and Mechanism by P. S. Kalsi, New Age International

Publishers.

14. Chromatographic Analysis of Pharmaceuticals, A. John, Adamovics, Cytogan

Corporation, Princeton, NJ.

15. Phytochemical Methods, J.B.Haroborne, Chapman and Hall, London and New York.

16. Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in Indian Medicine & Homeopathy).

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SEMESTER-II

QUALITY MANAGEMENT OF PHARMACEUTICALS (PH816.09)

Credits: 4 Theory Contact Hours Per week: 4 Theory


To make students familiar with the principles of Quality Management of Pharmaceuticals

and its application in pharmacy.



quality management of pharmaceuticals, which is important to maintain the quality and

safety of pharmaceutical products.




Sr no. Unit Minimum Number of

Contact Hours

Approx % weightage

1 Introduction to Quality Management System 2 4

2 Quality Tools for Total Quality Management 3 6

3 Approaches of quality management 10 15

4 Drugs and cosmetics act 1940 4 6

5 Quality Management System for API’s (GMP and ISO) 16 24

6 Handling out-of-specification situations 5 9

7 Good Distribution Practices 7 12

8 Packaging Aspects 11 20

9 Quality Management of Cosmetics 3 4

Total 60 100%

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1. Introduction to Quality Management System: 2

Introduction, Management responsibility, Quality system.

2.Quality Tools for Total Quality Management: 3

Pie charts & bar graphs, histograms, run charts, pareto charts, force field analyzer, brain storming

& affinity diagrams, tree diagrams, flow charts & modeling, scatter diagram and relations diagram

3. Approaches of quality management: 10

a) ISO 9000 series

b) Hazard and Risk Analysis in Pharmaceutical Products: Introduction, Principles of

HACCP, Application of HACCP system.

4. A brief introduction to Drug and Cosmetics act 1940 4

5. Quality Management System 16

• Contract review,

• Design and development control,

• Production and Material Management Control: Introduction, Importance,

Production Planning and Control, Purchasing, Inventory, Drug Store

Management.

• Control of Customer Supplied Product

• Product and Equipment identification and traceability,

• Manufacturing processing control,

• Change control

• Control of non-conforming product,

• Counterfeit products,

• Control of Quality Records,

• Quality system performance measurement.

6. Handling out-of-specification situations: 5

OOS results overview, Preventing OOS, Identification of critical parameters, Corrective and

Preventive Actions (CAPA).

7. Good Distribution Practices: 7

General principles, Regulation of the distribution of pharmaceutical products, Organization

and management, Personnel, Quality system, Premises, warehousing and storage, Vehicles

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and equipment, Shipment containers and container labeling, Dispatch and receipt,

Transportation and products in transit, Documentation, Repackaging and relabeling,

Complaints, Recalls, Returned products, Counterfeit pharmaceutical products, Importation

8. Packaging Aspects: 11

• Good packaging and good repackaging practices.

• Containers for Pharmaceuticals:

o Glass containers: Glass types, chemical performance, testing and quality control.

o Plastics containers: Classification of plastics, plastic polymers and their physico-chemical, mechanical and biological properties; Additives and fabrication processes. Plastic container for parenteral and transfusion sterile drip kits. Quality control testing and biological toxicity.

o Metal containers: Aluminum and tinplate, Drums, collapsible tubes and Aerosol containers, Lacquering, coating and lining.

• Paper and paper board: Types of paper, folding cartons, quality control testing of paper and paper board. Corrugated and solid fiber boards and boxes, Types of corrugation methods.

• Caps and Closures: Types caps closure liners, child resistant caps. Elastomeric closures for parenteral, classification of elastomers, physical, chemical and biological properties and their quality control.

• Labels and labeling: Types of labels, adhesives, inject and bar coding.

• Flexible packaging: Types of films, Co-extruded films, foils, coating and laminates, shrink and stretch films.

• Blister and strip packaging.

• Transit worthiness of package, Tamper evident packaging systems.

• Product-Package compatibility, stability of product and packaging material, packaging selection and development criteria.

• Line clearance

9. Quality Management of Cosmetics 3

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1. Pharmaceutical Quality Assurance and Management, K.P.Bhusari, U.D.Shivhare,

D.C.Goupale, PharmMed Press, Hyderabad.

2. Quality Assurance of Pharmaceutical (as per the compendia), WHO Geneva


Springer.

4. International Conference on Harmonisation guidelines.


Informa Healthcare.

6. Who Expert Committee On Specifications For Pharmaceutical Preparations, Forty-

Fourth Report, Who Technical Report Series, 957 (http://whqlibdoc.who.int/trs/

WHO_ TRS_ 957_ eng.pdf#page=95)

7. Pharmaceutical Industrial Management, G Vidhya Sagar, Pharma Book Syndicate,

Hyderabad

8. Encyclopedia of Pharmaceutical Technology Vol.1-3, Swarbric, J and Bolyln, J. C.,

Marcel Dekker, Inc., New York.

9. United States Pharmacopoeia-27(NF-22), 2004, United State of Pharmacoppeal

convention, INC, 12601 Twinbrook Parkway, Rockville, MD 20852.

10. Pharmaceutical Packaging Technology, Dean, D. A. Evans, E. R. and Hall, j. H., Taylor

and Francis, London.

11. Packaging of Pharmaceutical & Healthcare products, H. Lockhart, F. A. Paine,

Champman and Hall, London.

12. Handbook of Package Engineering by Joseph. F. Handlon.

13. Industrial Packaging by Fried man & Kipness.

14. Packaging of Pharmaceuticals, C.F. Ross.

15. Drug Stability, J.T. Carstensen, Marcel Dekker, New York.

16. The Theory and Practice of Industrial pharmacy, Lachmann, L., Lieberman, H.A. &

Kanig, J.I., Lea and Fibiger, CBS Publishers and Distributers, New Delhi.

17. Modern Pharmaceutics, Banker, G.S. & Rhodes, C.T., Marcel Dekker Inc. New York

and Basel


19. www.fda.gov

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SEMESTER-II

Practical-III (Advanced Pharmaceutical Analysis) (PH816.10)



• To get basic idea about method development and principles behind it for analysis of drugs from bio fluids and have hands on training on sophisticated analytical instruments.


• To get familiar with the principles and fundamentals of bioanalytical method

development

• To have practical exposure to the instrumental techniques in Pharmaceutical

analysis for checking assay and quality of formulations.


• Experiments to be performed in laboratory and Sophisticated Instrument lab. Outline of the course:

Sr No.

Title of the unit Minimum number of hours

Approx. Weightage

%

1. Analysis of different drugs from biological fluids and extraction procedures

12 10

2. Analysis of Biotech derived products using gel electrophoresis and other instrumental techniques

12 10

3. To study IVIVC correlation 6 5 4. To perform dissolution studies 6 5

5. Analysis of commonly abused drugs in their solid dosage form and in biological media

12 10

6. To design a protocol and perform forced degradation studies 12 15

7. Structure elucidation of pharmaceutical compounds 12 15 8. To perform HPTLC for phytoconstituents in herbal drugs 6 15

9. Spectral interpretation of some pharmaceutical compounds 6 10

10. Case studies on Impurity characterization (profiling)

6 5

Total 90 100%

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1. Analysis of different drugs from biological fluids and extraction procedures for Extraction

of Drugs from Biological fluids

2. Analysis of Biotech derived products using gel electrophoresis and other instrumental

techniques

3. To study IVIVC correlation of given data

4. To perform dissolution studies of pharmaceutical dosage forms

5. Analysis of commonly abused drugs in their solid dosage form and in biological media.

6. To design a protocol and perform forced degradation studies (stress studies) of any API

7. Structure elucidation of pharmaceutical compounds using different spectroscopic

techniques like UV-Visible, IR, NMR, Mass etc

8. To perform HPTLC for phytoconstituents in herbal drugs.

9. Spectral interpretation of some pharmaceutical compounds

10. Case studies on Impurity characterization (profiling)



2. The Analysis of Drugs in Biological Fluids, Joseph Chamberlain, CRC Press

3. EMEA for Bioanalytical method validation

4. Industrial guidelines for Bioanalytical method validation

5. BA-BE guidelines for BA-BE studies as per USFDA (CFR)

6. Spectroscopic identification of organic compounds. R.M. Silverstein, G.C. Bassler,

T.C. Morrill, Pub: John Wiley and Sons, NY.





10. Introduction to Spectroscopy, Pavia, Lapmann, Springer

11. Identification of Drugs and Pharmaceutical Formulations by Thin Layer

Chromatography, P. D. Sethi, CBS Publishers and Distributers, New Delhi.



13. Stereo Chemistry – Conformation and Mechanism by P. S. Kalsi, New Age

International Publishers.

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14. Chromatographic Analysis of Pharmaceuticals, A. John, Adamovics, Cytogan

Corporation, Princeton, NJ

15. Phytochemical Methods, J.B.Haroborne, Chapman and Hall, London and New York.

16. Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in Indian

Medicine & Homeopathy).

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SEMESTER-II Practical-IV (Pharmaceutical Validation & Documentation) (PH816.11)



• To get basic idea about validation and documentation in field of quality assurance.


• To get familiar with the principles and fundamentals of validation.

• To have practical exposure to the validation of different equipments.

• To achieve expertise in preparation of various documents.


• Experiments to be performed in laboratory. Outline of the course:

Sr

No.


number of

hours

Approx.

Weightage

%

1. Validation of various equipment 12 20

2. Validation of a processing area. 6 5

3. Validation of Air and Water. 6 5

4. Cleaning validation of equipment 12 10

5. Preparation of various documents 54 60

Total 90 100%

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1. Validation of following equipment: Autoclave, Hot air oven, Dry Powder Mixer,

Tablet Compression Machine

2. Validation of a processing area.

3. Validation of Air and Water

4. Cleaning validation of equipment.

5. To prepare following documents:

a. Standard Operating Procedure for following machines: Tablet Punching Machine and

Capsule Punching Machine. Preparation of calibration master plan.

b. To prepare Standard Operating Procedure for cleaning Class 100 Area

c. To prepare IQ, OQ & PQ protocol of any instrument

d. To prepare Analytical method validation protocol

e. To study Validation Master Plan for Sterile Dosage Manufacturing Unit

f. To prepare Specification and Method of analysis protocol for API

g. To prepare Master formula record (MFR) and study Batch formula record (BFR) for

any formulation

h. To prepare Protocols for Finished products and Raw materials.

i. To study In-process quality control (IPQC) protocol



Springer.

2. Pharmaceutical Validation Master Plan, Syed Imtiaz Haider, Informa Healthcare, U.K.

3. Pharmaceutical Process Validation, Robert A. Nash, Alfred H. Wachter, Informa

Healthcare.

4. Guidelines on cGMP and Quality of Pharmaceutical Products, S.Iyer, D.K.Publications,

Mumbai.


Informa Healthcare.

6. Validation in Pharmaceutical Industry, Concepts Approaches and Guidelines,

P.P.Sharma, Vandana Publications, Pvt. Ltd., Delhi.

7. Validation of Pharmceutical Process, Sterile products, F.J.Carleton, J.PAgallo, Marcel

Dekker, New York.

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SEMESTER II

COMMUNITY SERVICES-II (PH824.04)

(PRACTICAL)

Credits: 1 Contact hrs per week: 3

Course Description

• Students are undertaking a group research project. Students of each group choosing community service projects must commit at least 3 hours/week to their projects.

• Students in this course will have an opportunity to work collaboratively with community partners to identify needs in communities.

• Students will investigate, discuss, and plan methods of addressing identified needs within the community.

• Under the guidance of the instructor or an advisor, students will be actively involved in implementing a self-designed community service project.

Course Goals

• Promote active learning and responsible citizenship.

• Identify personal values, beliefs, attitudes, and philosophies.

• Promote collaborative learning.

• Strengthen ties between student and community; and community and college.

• Foster a commitment of service to others. Course Objectives

• Develop interpersonal skills necessary for being an active participant in a community

• Develop a learning community

• Investigate and identify needs within a community

• Develop a plan of action for responding to an identified need of the community Course Evaluation

Projects selected in Community services-II will be in continuation with Community

services-I. Evaluation will be based on final presentation and final report preparation.

The performance of every student will be evaluated as follows:

Approx. Weightage (%) Final report (assignment) 25 Final Presentation 75