,

Swami Ramanand Teerth Marathwada University, Nanded

Faculty of Pharmaceutical Sciences and Technology

M.Pharm Syllabus
Quality Assurance/ Quality Assurance Techniques
Cumulative Grade Point Average (CGPA)

Teaching-Evaluation Scheme and Course Content

Effective from September 2011

 Swami Ramanand Teerth Marathwada University, Vishnupuri, Nanded
M. Pharm. Quality Assurance / Quality Assurance Techniques
Teaching and Evaluation Scheme
(Cumulative Grade Point Average)
Effective from September 2011
Semester-I
*Course Subject Title Contact Hours/Week Credits
Code L T P Total
PHC-101 Advanced Analytical Techniques 03 01 - 04 04
PHC-102 Research Methodology and 02 01 - 03 03
Biostatistics
PHC-103 Regulatory Affairs and IPR 02 01 - 03 03
PQA-101 Quality and its Concepts 03 01 - 04 04
PHC-104 Lab-I: Analytical Techniques - - 06 06 04
PHC-105 Seminar One seminar/student 02
Total 10 04 06 20 20
Semester-II
*Course Subject Title Contact Hours/Week Credits
Code L T P Total
PQA-102 Pharmaceutical Process Validation 03 01 - 04 04
PQA-103 Method Development and Validation 03 01 - 04 04
PQA-104 Pharmaceuticals Stability Studies 02 01 - 03 03
PQA-105 Quality Assurance Approach and 02 01 - 03 03
Improvement
PQA-106 Lab-II : Quality Assurance - - 06 06 04
(General Laboratory in an area of
specialization)
PHC-106 Seminar One seminar/student 02
Total 10 04 06 20 20
*Course code PHC shall be common to all subject specialization, course code PQA shall be for Quality Assurance/
Quality Assurance Techniques.

Semester-III
PQA-107 Synopsis and Experimental Work: 04 Credits
End term progress and Presentation of Work: 04 Credits
Total: 08 Credits
Semester-IV

PQA-108 Dissertation: 06 Credits

Mid term presentation on work: 02 Credits
Defense (Viva-Voce) 04 Credits
Total: 12 Credits
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 FEATURES OF THE CREDIT SYSTEM

• Master’s degree would be of 60 credits each for specialization subjects.

• First and Second Semester will be of 20 credits each.
• Third and Fourth semester together will be of 20 credits.
• Semester I and II will have 04 theory courses (14 credits each for semester I & II), 01
practical course (04 credits) and 01 seminar (02 credits). Every student shall complete 60
credits in a four semesters.

Each subject/course has a specific number of credits that reflects its weightage. The number of
credits of a subject in a semester shall be as follows-

I) Each theory subject with 2/3/4 credits indicates-

A) 2 Credit Subject:
• 1 Credit is assigned to one lecture hour/week
• 1 Credit is assigned to tutorials, home assignment, interactions during seminar/s by expert
faculty
B) 3 Credit Subject:
• 2 Credits are assigned to two lecture hour/week
• 1 Credit is assigned to tutorials, home assignment, interactions during seminar/s by expert
faculty
C) 4 Credit Subject:
• 2 Credits are assigned to two lecture hour/week
• 1 Credit is assigned to tutorials, home assignment, interactions during seminar/s by expert
faculty
• 1 Credit is assigned to quizzes, review articles presentation within lecture hour.

II) Practical: 4 Credits are assigned to Six hours of laboratory work/batch/week.

III) Seminars: 02 credits are assigned to one seminar/student in semester I and II.

IV) Research Project/Work (20 credits):

The student shall undertake research project in the beginning of IIIrd semester and it
includes-
Semester-III
Synopsis and Experimental Work: 04 Credits
End term progress and Presentation of Work: 04 Credits
Total: 08 Credits
Semester-IV

Dissertation: 06 Credits
Mid term presentation on work: 02 Credits
Defense (Viva-Voce) 04 Credits
Total: 12 Credits

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 EVALUATION

* Full marks for 1/2 Credits: 50

Full marks for 3/4 Credits: 100
Full marks for 5/6 Credits: 200
Evaluation

Internal Evaluation (50%) Semester Examination (50%)

A student shall be continuously evaluated for his/her academic performance in a subject/course

by home assignments, seminars, quizzes, projects and mid term examination. The distribution of
weightage for each component shall also be decided by department/mentor at the beginning of
the course. General guidelines for weightage is as follows-

I) Theory:

i) Quizzes, home assignments, regularity in assigned work (15%):

There shall be at least 03 home assignments or 02 Quizzes for each theory course which is
under the purview of Department Head/Mentor and it should be decided at the beginning of
Semester. Home assignments given to students should be on course content and shall
include question-answering, review of articles, review and compilation of any course
content or as decided by Department head/mentor.
ii) Group Seminars/ presentation, Group Discussion (15%):
There shall be at least 03 Group Seminar/Presentation or 03 Group Discussions for each
theory course, in a group of 3-4 students. The philosophy should be decided at the
beginning of Semester.
iii) Mid Term Examination (20%):
Mid Term examination for each theory course shall be conducted for 20 marks each. There
shall be only one Mid Term Examination and paper should include both objective &
subjective question.

i) Quizzes, home assignments, regularity in assigned work: 15%

ii) Group Seminars/ presentation, Group Discussion: 15%
(Group of 3-4 students for at least 3 times in semester)
iii) Mid Term Examination: 20%
iv) Semester Examination: 50%
--------------
Total: 100%

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II) Practical:

i) Day to Day Evaluation (40%):

For practical course, 20% weightage shall be given to Application, Technical Credibility
and Interaction and 20% weightage for Lab. Work, Reporting and Record Keeping. There
shall be no internal examination for practical course.
ii) Quizzes, Projects, regularity in assigned work (10%):
There shall be at least 02 projects (theoretical or experimental) or 02 Quizzes for practical
course which is under the purview of Department Head/Mentor and it should be decided at
the beginning of Semester.
iii) Semester Examination (50%):
For practical semester examination, panel includes internal examiner and one external
examiner.

i) Application, Technical Credibility, Interactions: 20%

ii) Lab. Work, Reporting, Record keeping: 20%
iii) Quizzes, Projects, regularity in assigned work: 10%
iv) Semester Examination: 50%
--------------
Total: 100%

III) Seminars: (Semester-I and Semester-II)

There shall be one seminar/student in Ist and IInd semester (2 credits) evaluated for 50
marks by Internal Examiner Panel. Internal examiner panel shall include at least 03
members as-
a) Head of Institute/ Academic Associate
b) One subject expert at the level of Assistant/Associate professor or Professor
c) Mentor

Students are evaluated on following parameters-

i) Ideology of topic: 10%

ii) Material and methodology of topic: 30%
iii) Depth of knowledge, Presentation of topic: 30%
iv) Defense and justification of topic: 20%
v) Reference work: 10%
--------------
Total: 100%
IV) Research Project/Work:

The panel for evaluation of dissertation shall consists-

a) Chairman : Head of Institute/Faculty Dean/HOD/Director of Campus school
b) Internal Examiner : Guide/Mentor
c) External Examiner : From the panel of University approved Examiner from institute or
Outside Institute

5
 The Internal and External Examiner will jointly assign the marks for dissertation out of 200 and
for viva-voce out of 100 marks.
The allotment of marks of the dissertation shall be as under

1. Introduction : 20
2. Literature Review : 20
3. Experimental work/Methodology : 70
4. Result/Conclusion Drawn : 40
5. Originality of work : 20
6. Scope for further research : 10
7. Reference Work : 20
__________________
Total : 200
VIVA-VOCE:
The allotment of marks of the viva-voce shall be as under-

1. Methods/ Techniques adopted : 30

2. Presentation : 30
3. Discussion & Defense : 40
__________________
Total : 100

• Marks for each course would be converted to grades as shown in Table

Mark Range Academic

Grade Grade Point
Out of 100 Out of 50 Performance
100-90 50-45 O 10 Outstanding
89-80 44-40 A 09 Excellent
79-70 39-35 B 08 Very Good
69-60 34-30 C 07 Good
59-50 29-25 D 06 Satisfactory
49-45 24-23 E 05 Pass
44-00 22-00 *F 00 Fail

* Student with F grade in a course would be granted credit for that course but not the
grade for that course and shall have to clear the concerned course within 1.5 year from
appearing for first time in the concerned paper.

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 Calculation of CGPA of student

Step 1: Assigning Grade point: As shown in table

Step 2: Calculating Quality Point for each course:
Quality point = Grade Point * Credit

Step 3. Total Quality Point of Semester:

Add all the Quality Point earned by student for all courses of semester to get Total
Quality Point.
Step 4. Calculating Cumulative Grade Point Average:

1. For each Semester:

CGPA= Total Quality Points earned in semester
Total Credits earned in semester

2. At the end of First Year:

CGPA= Total Quality Points earned in semester I and II
Total Credits earned in semester I and II

3. At the end of Second Year: (Final CGPA)

Final CGPA= Total Quality Points earned in semester I, II, III, IV

Total Credits earned in semester I, II, III, IV

Division/ Equivalence:
CGPA Range Class of Honours
7.00 & above First Class
5.00 & above and Pass
less than 7.0

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 Swami Ramanand Teerth Marathwada University, Nanded
M.Pharm. Syllabus
M. Pharm. (Semester – I)
Quality Assurance/Quality Assurance Techniques
Subject code: PHC-101
Subject : Advanced Analytical Techniques (TH) (4 Credits)

I. Spectroscopic Methods:
1. UV- Visible spectroscopy: Introduction, Basic principles, applications; Absorption spectra of
organic compounds & complexes illustrating the phenomenon & its utilization in qualitative &
quantitative studies of drugs; calculation of absorption maximum of unsaturated hydrocarbons.
2. IR Spectroscopy: Interaction of infrared radiation with organic molecules & its effect on bonds;
Instrumentation- dispersive IR spectrophotometer, FTIR; sample handling, interpretation of
spectra.
3. NMR Spectroscopy: Fundamental principles of NMR, Instrumentation; Chemical shifts concept,
spin-spin coupling, s[in-spin decoupling, shielding & deshielding, solvents; interpretation of
spectra; introduction & application of 13C-NMR and 2D NMR.
4. Mass Spectroscopy: Basic principles & instrumentation; Ionization techniques, mass spectrum &
its characteristics, molecular ion, metastable ion, fragment ions; fragmentation process &
patterns, fragment characteristics in relation to parent structure & functional groups; relative
abundance of isotopes & their contribution to characteristic peaks.
II. Chromatographic Techniques:
1. Classification of chromatographic methods based on mechanism of separation & their basic
principles.
2. Gas Chromatography: Instrumentation, column efficiency parameters, derivatisation methods,
application in pharmaceutical analysis.
3. Liquid Chromatography: Comparison of GC & HPLC, instrumentation in HPLC, phase packing
materials, column selection, mobile phase selection, efficiency parameters, application in
pharmaceutical analysis.
4. Instrumentation & pharmaceutical applications of HPTLC, Ion exchange chromatography, Gel
permeation chromatography, Chiral chromatography, Flash chromatography, Supercritical Fluid
chromatography.
III. Other Analytical Techniques:
1. Thermal Analysis: Theory, instrumentation & applications of Thermo-gravimetric analysis,
differential thermal analysis, differential scanning calorimeter.
2. Immunochemical Techniques: Immuno-electrophoresis, immuno-precipitation, ELISA, radio-
immuno assay.
3. Powder X-ray Diffraction: Instrumentation and pharmaceutical applications.

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References:
th
1. Skoog, DA, Holler, FJ, Crouch, SR. Principles of instrumental analysis. 6 ed., Baba Barkha Nath
printers, Haryana, 2007
th
2. Silverstein, RM, Webstar, FX. Spectrometric identification of organic compounds. 6 ed., John
Wiley & Sons (Asia) Pvt. Ltd., Singapore, 2005
rd
3. William Kemp. Organic spectroscopy, 3 ed., Palgrave, New York, 2006
nd
4. Jag Mohan, Organic spectroscopy: Principles and Applications, 2 ed., Narosa publishing
house Pvt Ltd., New Delhi, 2005
rd
5. Conners KA. A Text book of pharmaceutical analysis, 3 ed., John Wiley & Sons, Singapore,
2004
th
6. Willard HH, Merritt LL, Dean JA, Settle FA. Instrumental methods of analysis, 7 ed., CBS
Publishers & Distributors, New Delhi, 1986
th
7. Pavia DL, Lampman GM, Kriz GS, Vyvyan JA. Introduction to spectroscopy. 4 ed., Brookescole
publishers, California, 2008
th
8. Sharma BK. Instrumental methods of chemical analysis, 25 Ed., Goel Publishing house,
Meerut, 2006
th
9. Beckett, AH, Stenlake, JB. Practical pharmaceutical chemistry, Part I & II, 4 ed., CBS
Publishers & distributors, New Delhi, 2004
th
10. Ewing, GW. Instrumental methods of chemical analysis, 5 ed., McGraw Hill Book Company,
New York, 1985
nd
11. Schirmer, RE. Modem methods of pharmaceutical analysis, Vol. I & II, 2 ed., CRC Press,
Florida, 2000
rd
12. Moffat, AC, Osselton, MC, Widdop, B. Clarke's analysis of drugs and poisons, Vol. I & II, 3
ed., K.M. Varghese Company, Mumbai, 2004

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 Swami Ramanand Teerth Marathwada University, Nanded
M.Pharm. Syllabus
M. Pharm. (Semester – I)
Quality Assurance/Quality Assurance Techniques
Subject code: PHC-102
Subject : Research Methodology and Biostatistics (TH) (3 Credits)
I) Research Methodology
1. Introduction: Meaning & Objectives of research, types of research, approaches to research;
Research methods, research process; Criteria for good research, common problems, qualitative
& quantitative research methods.
2. Research Topic: Selection of research problem, research design; meaning, concept & features of
research design, experimental design, plan of research work.
3. Data Collection: Primary & secondary data collection method, design of questionnaires for data
collection, identification of sources of information, searching and classifying information;
compilation, processing & analyzing of data & information.
4. Interpretation of Results and Presentation: Meaning of interpretation, techniques of
interpretation; scientific writing & report preparation, fundamentals of scientific writing, report
preparation, types & layout of report, precautions in writing research report; statistical aspects
of research output.
5. Principles of validity & reliability of research work, ethical aspects of research methodology.
6. Developing research proposals: Format of research proposals, Individual & Institutional
research proposals.
II) Biostatistics
1. Introduction, its role and uses. Collection, organization, graphic & pictorial representation of
data, measurement of central tendencies & dispersion; degree of freedom, standard deviation,
standard error, Coefficient of variation, Probability, Sample and Sampling method
2. Estimation and Hypothesis testing: Null Hypothesis, confidence level, Point & interval
estimation, concept of hypothesis testing & types of error, Student ‘t’ test, Chi-Square test.
3. Linear regression and Correlation: Analysis of variance (one way & two way), Factorial design
4. Brief review of non parametric tests, experimental design in clinical trials, statistical test for
bioequivalence, Dose-Response study, statistical quality control; validation, optimization
techniques & screening design, significance of coefficient of correlation, non-linear regression,
application of software for statistical calculations.

References:
(1) Research in education – John W. Best Jems V. Kahn
(2) Research methodology – C. R. Kothari
(3) Methodology and techniques of social research – Willkinson and Bhandarkar
(4) Presentation skills – Michel Halton – Indian society for institute education
(5) Practical introduction to copyrights – Gavin Mofariane
(6) Thesis projects in sciences and engineering – Richard M. Devis
(7) Scientist in legal system – Ann Labor Science
(8) Thesis and assessment writing – Janolthon Anderson

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(9) Writing a technical paper – Donald Manzel
(10)Effective business report writing – Lel and Brown
(11)Protection of industrial property rights – Purshottam Das and Gokul Das
(12)Spelling for millions – Edna Furmess
(13)Preparation for publications – King Edwards hospital foundation for London
(14)Information technology – The hindu speeks
(15)Documentation – genesis and development – 3792.
(16)Ayurveda and modern medicine – R. D. Lele
(17)How to write and publish a scientific paper – Robert A. Day Cambridge University Press 4th
Edition, 1994
(18)Lecture notes on patent TIFAC: DOC: 022, TIFAC July 2002.
(19)Introduction to Statistical Methods- C. B. Gupta
(20)A first course in Mathematical Statistics- C. E. Weatherborn
(21)Introduction to Biostatistics-Mahajan
(22)Experimental Pharmacology by S K Kulkarni.

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 Swami Ramanand Teerth Marathwada University, Nanded
M.Pharm. Syllabus
M. Pharm. (Semester – I)
Quality Assurance/Quality Assurance Techniques
Subject code: PHC-103
Subject : Regulatory Affairs and IPR (TH) (3 Credits)

I. Regulatory Affairs:
1. Historical perspectives, organization structure, activities and responsibilities of drug regulatory
agencies in India, US, EU, etc.
2. Concepts of total quality management, Good laboratory practices and ISO; Quality assurance &
quality control for APIs and other intermediates in process & finished products. GMP for bulk
drugs & formulations, Good clinical practice guidelines. US regulatory practices, ICH guidelines.
3. Validation of process, equipments, procedures, validation master plan. Documentation like
master records, batch records, regulatory compliance records, distribution records, drug recall
registers, management review records.
4. Regulatory Acts: Drugs & Cosmetic act-1940 & rules 1945 with special relevance to schedule M,
Y, U; latest drug price control order & latest drug policy; Pollution & environmental control act.
II. Intellectual Property Rights:
1. Introduction: Scope, Objectives & IPR in pharmacy, Indian legal system & its role in IPR;
importance for pharma industry.
2. Concept of property with respect to intellectual creativity; Tangible & Intangible property,
concept of IPR, scope & nature of patents, copyrights, trade mark, geographical limitations.
3. Patent and its Practical aspects: Indian Patent Act 1970, Patenting in India & abroad, role of
international organization WTO, WIPO, EPO in patent act; practical aspects of patent filing,
components of a patent application in India, PCT filing, patent infringement & litigation therein,
commercialization & licensing
4. Ethics in IPR: Positive & negative aspects, drug related controversies, traditional knowledge,
crops & life forms, current strategies & solutions.

References:
1. Drugs & Cosmetics Act 1940 and rules there under.
2. Drugs Laws by Hussain.
3. Indian Patent Act.
4. Quality assurance & GLP by Y. Anjaneyulu.
5. Quality control & Application by Bentrand L. Hanser.
6. Quality assurance in Analytical chemistry by Werner Funk..
7. Guidelines of various countries like MCA, TGA, ICH.
8. GLP regulation by Alen Hirsch Vol 38 Marcel Decker series
9. GMP for pharmaceuticals forth edition by S. Willing, J. Stocker Marcel Decker series 1997.
10. I.P., B.P., U.S.P. International Pharmacopoeia

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 Swami Ramanand Teerth Marathwada University, Nanded
M.Pharm. Syllabus
M. Pharm. (Semester – I)
Quality Assurance/Quality Assurance Techniques
Subject code: PHC-104
Subject : Lab-I: Analytical Techniques (4 Credits)
*A minimum of 13 Practical’s shall be conducted from the given modules.

Module-1
UV/Visible spectrum scanning of a few organic compounds for UV- absorption and correlations
of structures and isosbestic point in case of mixtures.

Module-2
Effect of solvents and pH on UV spectrum of drugs

Module-3
Estimation of multi component formulation by UV- Spectrophotometer in formulations

Module-4
Experiments based on the application of derivative spectroscopy.

Module-5
Experiments based on HPLC (Isocratic and Gradient elution) techniques.

Module-6
Interpretation of drugs by IR spectra

Module-7
Workshop of spectroscopy: (UV, IR, NMR, MASS) structural elucidation of few compounds

Module-8
Separation of protein drug substances by electrophoresis

Module-9
Any other relevant experiments based on theory.

13
 Swami Ramanand Teerth Marathwada University, Nanded
M.Pharm. Syllabus
M. Pharm. (Semester –I)
Quality Assurance/Quality Assurance Techniques
Subject code : PQA-101
Subject : Quality and Its Concepts (4 Credits)
• Quality: Concept of quality, nature of product quality, study of various approaches for
quality like Deming’, Juran, Crosby, Feigenbaum, Shikaw.
• Quality income and cost. TQM awards and prizes.
• Quality benchmarking, details of international standards (ISO, GMP, GLP, TGM, VAN and
ISI), its need and fact sheet evaluation (should include review or statistics of industries
implemented these standards with those which have not implemented these)
• Role of quality audit and quality circle in quality assurance.
• Quality assurance and GLP, implementing of GLP in non GLP analytical laboratory.
• Process management, project management, strategic development and product
development.
• Measurement of quality, information and decision making or utilization of data.
• Quality operations, its inspection and test used for it.
• Human resource and training for quality.
• Market survey, customer demand and marketing in addition to supplier and customer
relationships.
• Quality, society and national culture.
• Computerized system- software development, computer applications and quality
system.
• Requirements of product registration, in India and other countries (USA, UK, Japan and
Europe etc).
REFERENCES:
1. Juran’s Quality Handbook, 5th Ed, by J M Juran, A B Godfrey, McGrawHill International
Edition
2. Total Quality Management- Guiding Principle for Application, J. P. Peker, ASTM manual
series, Philadelphia.
3. Total Quality Management – The Key to Business Improvement, Champman and Hall,
Londan.
4. Quality Assurance Guide by Organisation of Pharmaceutical products of India.
5. ISO 9000 and Total Quality Management – Sadhank. G. Ghosh.
6. Project Management, Clifford F. Gray and Erik W., Larson Publisher: McGraw Hill
Company.
7. Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related
Materials (v. 1) by WHO.

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8. FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices and Good Drug
Regulatory Practices: a Regulatory Affairs Quality Manual (Good Drug Development
Series) – Helene I. Dumitriu
9. ISO 9000 Quality Systems Handbook - updated for the ISO 9001:2008 standard, Sixth
Edition: Using the standards as a framework for business improvement by David Hoyle
(Paperback - July 10, 2009).
10. Total quality management: strategies and techniques proven at today's most successful
companies (Portable Mba Series) by Stephen George and Arnold Weimerskirch
(Hardcover - Feb. 1998).

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 Swami Ramanand Teerth Marathwada University, Nanded
M.Pharm. Syllabus
M. Pharm. (Semester – II)
Quality Assurance/Quality Assurance Techniques
Subject code : PQA-102
Subject : Pharmaceutical Process validation (4 Credits)
• Introduction to pharmaceutical validation: definition, manufacturing process model,
scope of validation, advantage of validation, organization for validation, validation of
master plan, types of process validation, design qualification, installation qualification,
operational qualification and performance qualification of facilities.
• Process validation: prospective, concurrent, retrospective and revalidation,
• Process validation of formulations like tablets, capsules, ointment/creams, liquid orals,
sterile dosage form which should include following aspects-
o Personnel and organization
o Raw materials
o Equipments (e.g. Dry powder mixers, fluid bed and tray dryers, tablet
compression machine, capsule filling machines etc)
o Area, premises and environment including storage of raw materials to finished
products
o Water (validation of pharmaceutical water system and pure steam),
o Packaging and labeling controls and its validation
o Cleaning validation: cleaning of equipment, cleaning of facilities
o Validation of Integrated lines by media fill test.
o Validation of HVAC system
• Vendor Certification.
• Validation of compressed air, validation of water and air handling systems
• Validation of existing equipment and utilities validation
• Computer system validation including installed softwares
• Pharmaceutical development of drug substance and drug product, formulations,
manufacture and supply of materials, labeling and presentation, stability and storage,
purity, compatibility, disposal.
REFERENCES:
1. Pharmaceutical Process Validation, B. T. Loftus and R. A. Nash, Drugs and Pharm Sci.
Series, Vol. 129, Marcel Dekker Inc., New York.
2. Pharmaceutical Packaging Technology, Dean, D. A. Evans, E. R. and Hall, J. H., Taylor and
Francis, London.
3. Validation of Aseptic Pharmaceutical Processes, Carleton and Agalloco, Marcel Dekker
Inc., New York.
4. Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and
Biotechnology Industries by Syed Imtiaz Haider and Erfan Syed Asif

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5. Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and
Regulatory Compliance, Second Edition by Guy Wingate
6. Pharmaceutical Process Scale-Up”, Michael Levin, Drugs and Pharm. Sci. Series, Vol. 157,
Marcel Dekker Inc., New York.
7. Pharmaceutical Packaging Technology, Dean, D. A. Evans, E. R. and Hall, J. H., Taylor and
Francis, London.

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 Swami Ramanand Teerth Marathwada University, Nanded
M.Pharm. Syllabus
M. Pharm. (Semester – II)
Quality Assurance/Quality Assurance Techniques
Subject code : PQA-103
Subject : Method Development and Validation (4 Credits)
• Application of process analytical technology (PAT) in quality assurance
• Qualification validation and calibration of equipment. Analytical and bioanalytical
method validation
• Calibration and validation of various instruments used for drug analysis such as UV-
Visible Spectrophotometer, IR spectrophotometer, spectrofluorimeter, HPLC, HPTLC and
GC.
• Regulatory requirement in pharmaceutical analysis – US-FDA, ICH, PAC-ALTS: Post
approval changes – analytical testing laboratory site etc.
• Analysis of drug from biological fluids
• Application of analytical methods to product obtained through genetic engineering,
Amino acid sequence analysis, tryptic mapping, ion exchange amino acid analysis,
isoelectric focusing etc.
• Application of analytical methods to product obtained from natural sources (extracts,
herbal formulations, isolated compounds, modern herbal formulations) (Compendial
methods for evaluation of crude drug and herbal formulation)
• Dosage form impurity profile and its validation
• Organization & personnel, responsibilities, training and records. Equipment selection
purchase specifications, maintenance, clean in place for analytical department
• Premises - location, design, plant layout, construction maintenance and utilities and
services like gas, water for analytical department
REFERENCES:
1. Pharmaceutical Analysis – Modern Methods – Part A, Part B, J. W. Munson, Marcel
Dekker, NY.
2. Spectroscopic identification of organic compounds. John Dyer, Willy, NY.
3. Organic Spectroscopy W. Kemp, NY.
4. NMR spectroscopy (Basic Principles, concepts and application in Chemistry) Herald
Gunther, (John Wiley and Sons), NY.
5. Spectroscopic identification of organic compounds. R.M. Silverstein, G.C. Bassler, T.C.
Morrill, Pub: John Wiley and Sons, NY.
6. Quality control of herbal drugs: an approach to evaluation of botanicals, Pulok K.
Mukherjee, 2002, Business horizons.
7. Encyclopedia of Pharmaceutical Technology Vol.1-3, Swarbric, J and Bolyln, J. C., Marcel
Dekker, Inc., New York.

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8. United States Pharmacopoeia-27(NF-22), 2004, United State of Pharmacoppeal
convention, INC, 12601 Twinbrook Parkway, Rockville, MD 20852.
9. The International Pharmacopoeia Vol. 1,2,3,4, General methods of analysis and quality
specifications for pharmaceutical substances, excipients, dosage forms.
10. Phytochemical Methods, J.B.Harborne, Chapman and Hall, London and New York.
11. Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in Indian
Medicine and Homeopathy).

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 Swami Ramanand Teerth Marathwada University, Nanded
M.Pharm. Syllabus
M. Pharm. (Semester – II)
Quality Assurance/Quality Assurance Techniques
Subject code : PQA-104
Subject : Pharmaceutical Stability Studies (3 Credits)
• Stability aspects: Basic concept and objectives of stability study.
• Regulatory requirement for stability studies: A very brief introduction to FDA and
WHO guidelines. Detail study of ICH guidelines [Q1A (R2), Q1B, Q1C, Q1D, Q1E,
Q1F, Q5C].
• Kinetic principles applied for stability evaluation and their applications in
predicting shelf life and half life of pharmaceutical formulations. Importance of
accelerated stability study.
• Degradation pathways (Degradation by hydrolytic, oxidative, reductive,
photolytic, etc) and stabilization methods for formulation.
• Stability indicating assays and its importance
• Stability testing and dating of solid and liquid dosage forms:
• Different approaches for stability testing of solid and liquids, kinetic principles,
physical and chemical stability testing of pharmaceutical dosage forms and
packages.
• Product life-cycle management
• Product liability and compensation
• Stability issues related to proteins and insulin type formulations
• Stability issues related to herbal formulations, extracts, fractions and natural
products/isolated compounds.
• Stability issues for vaccines and biological products
REFERENCES:
1. Drug Stability, J.T. Carstensen, Marcel Dekker, New York.
2. Chemical Stability of Pharmaceuticals-A Handbook for Pharmacists, Kenneth Connors,
John Wiley and Sons, Inc.
3. Good Drug Regulatory Practices: a Regulatory Affairs Quality Manual (Good Drug
Development Series) – Helene I. Dumit
4. United States Pharmacopoeia-27(NF-22), United State of Pharmacoppeal convention,
INC, 12601 Twinbrook Parkway, Rockville, MD 20852.
5. The International Pharmacopoeia Vol. 1,2,3,4, General methods of analysis and quality
specifications for pharmaceutical substances, excipients, dosage forms.
6. Phytochemical Methods, J.B.Harborne, Chapman and Hall, London and New York.
7. Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in Indian
Medicine and Homeopathy).

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 Swami Ramanand Teerth Marathwada University, Nanded
M.Pharm. Syllabus
M. Pharm. (Semester – II)
Quality Assurance/Quality Assurance Techniques
Subject code : PQA-105
Subject : Quality Assurance Approach and Improvement (3 Credits)

• Quality improvement process

• Quality in research and development
• Complaints and recalls: evaluation of complaints, recall procedure, related records and
documents.
• Quality control laboratory – responsibilities and laboratory practices. Routine controls
on instruments, reagents, sampling plans, standard test procedures and protocols,
control on animal house, data generation and storage, quality control documentation
and audits of QC facilities.
• Finished product release, quality review, quality audits and batch release documents.
• Validation and security measures for electronic data and computer assisted process.
• Calibration and validation of master plan
• Cosmetics, biotechnological, microbiological products & regulations, medical device
regulations; fraud and professional misconduct
REFERENCES:
1. Encyclopedia of Pharmaceutical Technology Vol.1-3, Swarbric, J and Bolyln, J. C., Marcel
Dekker, Inc., New York.
2. United States Pharmacopoeia-27(NF-22), 2004, United State of Pharmacoppeal
convention, INC, 12601 Twinbrook Parkway, Rockville, MD 20852.
3. The International Pharmacopoeia Vol. 1,2,3,4, General methods of analysis and quality
specifications for pharmaceutical substances, excipients, dosage forms.
4. Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in Indian
Medicine and Homeopathy).
5. Juran’s Quality Handbook, 5th Ed, by J M Juran, A B Godfrey, McGrawHill International
Edition
6. Official books like IP, BP, USP, etc of recent editions

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 Swami Ramanand Teerth Marathwada University, Nanded
M.Pharm. Syllabus
M. Pharm. (Semester – II)
Quality Assurance/Quality Assurance Techniques
Subject code : PQA-106
Subject : Lab-II: Quality Assurance
(General Laboratory in an area of Specialization) (4 Credits)
*A minimum of 15 Practical’s shall be conducted from at least 08 modules. Module 1 is
compulsory. A right side figure indicates maximum practical conducted from single module.

Module 1: Prerequisite (01)

Basics of instrumentation, validation documentation
Module 2: (03)
1) Quantitative estimation by UV, HPLC
2) Acquaintance with working or principles of major spectroscopic and chromatographic
techniques (IR, NMR, MS, AAS, GC, HPTLC and HPLC etc
Module 3: (02)
1. Method development and validation using UV, HPLC and HPTLC
Module 4: (03)
1. Quantization of different phytoconstituents from extracts and herbal formulation by
Spectroscopic, HPLC and HPTLC method
Module 5: (02)
1. Stability indicating assay methods
Module 6: (02)
1. Impurity profile (AIP, formulations)
2. Quantitative estimation of drugs in biological fluids
Module 7: (04)
1. Validation of following equipment:
Autoclave, hot air oven, powder mixer (dry), tablet compression machine and
equipments required for formulations
2. Validation of a processing area.
3. Cleaning validation of equipment.
4. Validation of tablet, capsule, liquid (oral, topical etc) manufacturing facilities
5. Evaluation equipments validation
Module 8: (01)
1. Preparation of calibration master plan
Module 9: (02)
1. Evaluation and validation of packaging materials & facilities.
2. Test of packaging materials, cartons, aluminum foils, strip packing, blister packing,
ampoules, vials, etc.

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Module 10: (01)
1. Software, computer system validation.
Module 11: (01)
Documentation involved in above process

REFERENCES:

1. Practical Pharmaceutical Chemistry (part II) by Beckett and Stenlake

2. Interpretation of Mass Spectra of organic compounds-B. Kienicz, C. Djerassi
3. Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and
4. Biotechnology Industries by Syed Imtiaz Haider and Erfan Syed Asif
5. Pharmaceutical Process Validation – Robert A. Nash, Alfred H. Wachter.
6. Pharmaceutical Analysis – Modern Methods – Part A, Part B, J. W. Munson, Marcel Dekker,
NY.
7. United States Pharmacopoeia-27(NF-22), 2004, United State of Pharmacopeial convention,
INC, 12601 Twinbrook Parkway, Rockville, MD 20852.
8. British Pharmacopoeia, 2004, The British Pharmacopoeia commission office, Market Tower,
Nine Elms Lane, London.
9. Indian Pharmacopoeia-2007, Indian pharmacopoeia commission, Sector-23, Raj Nagar,
Ghaziabad.
10. Chromatographic Analysis of Pharmaceuticals, A. John, Adamovics, Cytogan Corporation,
Princeton, NJ.
11. Clinical Pharmacotherapecutics, edited by Kamalesh Kohli, Elsevier Publication.
12. Biological standardization by J.H. Burn, D.J. Finney and L.G. Goodwin.
13. Pharmaceutics of Solids and Solid dosage form by Cartensens.
14. Advance in Pharm. Sciences by Bean and Beckett.
15. Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related
Materials (v. 1) by WHO.
16. Good Drug Regulatory Practices: a Regulatory Affairs Quality Manual (Good Drug
Development Series) – Helene I. Dumitriu.
17. Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and
Regulatory Compliance, Second Edition by Guy Wingate.
18. Relevant articles from journals.
19. Quality control of herbal drugs: an approach to evaluation of botanicals, Pulok K.
Mukherjee, 2002, Business horizons.
20. Pharmaceutical Packaging Technology, Dean, D. A. Evans, E. R. and Hall, j. H., Taylor and
Francis, London.
21. Packaging of Pharmaceutical and Healthcare products, H. Lockhart, F. A. Paine, Champman
and Hall, London.
22. Packaging of Pharmaceuticals, C.F. Ross.
23. Drug Stability, J.T. Carstensen, Marcel Dekker, New York.
24. Chemical Stability of Pharmaceuticals-A Handbook for Pharmacists, Kenneth Connors, John
Wiley and Sons, Inc.

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