Quality Assurence Syallbus
Quality Assurence Syallbus
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M. PHARM. PHARMACEUTICAL QUALITY
ASSURANCE (MQA)
181
MODERN PHARMACEUTICAL ANALYSIS (MPA101T)
Scope
This subject deals with various advanced analytical instrumental techniques for
identification, characterization and quantification of drugs. Instruments dealt are NMR, Mass
spectrometer, IR, HPLC, GC etc.
Objectives
After completion of course student is able to know about chemicals and excipients
The analysis of various drugs in single and combination dosage forms
Theoretical and practical skills of the instruments
THEORY 60
HOURS
2 NMR spectroscopy: Quantum numbers and their role in NMR, Principle, 10 Hrs
Instrumentation, Solvent requirement in NMR, Relaxation process, NMR signals in
various compounds, Chemical shift, Factors influencing chemical shift, Spin-Spin
coupling, Coupling constant, Nuclear magnetic double resonance, Brief outline of
principles of FT-NMR and 13C NMR. Applications of NMR spectroscopy.
182
4 Chromatography: Principle, apparatus, instrumentation, chromatographic 12 Hrs
parameters, factors affecting resolution, isolation of drug from excipients, data
interpretation and applications of the following:
a) Thin Layer chromatography
b) High Performance Thin Layer Chromatography
c) Ion exchange chromatography
d) Column chromatography
e) Gas chromatography
f) High Performance Liquid chromatography
g) Ultra High Performance Liquid chromatography
h) Affinity chromatography
i) Gel Chromatography
183
QUALITY MANAGEMENT SYSTEMS (MQA101T)
Scope
Objectives
THEORY 60 Hrs
184
12 Hrs
12 Hrs
4. Drug Stability: ICH guidelines for stability testing of drug substances and drug
products.
Study of ICH Q8, Quality by Design and Process development report
Quality risk management: Introduction, risk assessment, risk control, risk review,
risk management tools, HACCP, risk ranking and filtering according to ICH Q9
guidelines
12 Hrs
185
Benchmarking: Definition of benchmarking, Reasons for benchmarking, Types of
Benchmarking, Benchmarking process, Advantages of benchmarking, Limitations of
benchmarking
4 Hrs
REFERENCES:
1. Implementing Juran's Road Map for Quality Leadership: Benchmarks and Results, By
Al Endres, Wiley, 2000
2. Understanding, Managing and Implementing Quality: Frameworks, Techniques and
Cases, By Jiju Antony; David Preece, Routledge, 2002
3. Organizing for High Performance: Employee Involvement, TQM, Reengineering, and
Knowledge Management in the Fortune 1000: The CEO Report By Edward E. Lawler;
Susan Albers Mohrman; George Benson, Jossey-Bass, 2001
4. Corporate Culture and the Quality Organization By James W. Fairfield-Sonn, Quorum
Books, 2001
5. The Quality Management Sourcebook: An International Guide to Materials and
Resources By Christine Avery; Diane Zabel, Routledge, 1997
6. The Quality Toolbox, Second Edition, Nancy R. Tague, ASQ Publications
7. Juran's Quality Handbook, Sixth Edition, Joseph M. Juran and Joseph A. De Feo, ASQ
Publications
8. Root Cause Analysis, The Core of Problem Solving and Corrective Action, Duke
Okes, 2009, ASQ Publications
186
QUALITY CONTROL AND QUALITY ASSURANCE (MQA102T)
Scope:
This course deals with the various aspects of quality control and quality assurance
aspects of pharmaceutical industries. It covers the important aspects like cGMP, QC tests,
documentation, quality certifications, GLP and regulatory affairs.
Objectives:
Upon completion of this course the student should be able to
Understand the cGMP aspects in a pharmaceutical industry
To appreciate the importance of documentation
To understand the scope of quality certifications applicable to Pharmaceutical
industries
To understand the responsibilities of QA & QC departments.
THEORY
60 Hrs
1. Introduction: Concept and evolution and scopes of Quality Control and Quality
Assurance,
Good Laboratory Practice, GMP, Overview of ICH Guidelines - QSEM, with special
emphasis on Q-series guidelines.
Good Laboratory Practices: Scope of GLP, Definitions, Quality assurance unit,
protocol for conduct of non clinical testing, control on animal house, report preparation
and documentation. CPCSEA guidelines.
12 Hrs
187
3. Analysis of raw materials, finished products, packaging materials, in process
quality control (IPQC), Developing specification (ICH Q6 and Q3), purchase
specifications and maintenance of stores for raw materials.
In process quality control and finished products quality control for following dosage
forms in Pharma industry according to Indian, US and British pharmacopoeias:
tablets, capsules, ointments, suppositories, creams, parenterals, ophthalmic and
surgical products (How to refer pharmacopoeias).
10 Hrs
REFERENCES
1 Quality Assurance Guide by organization of Pharmaceutical Procedures of India, 3rd
revised edition, Volume I & II, Mumbai, 1996.
2 Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol. 69, Marcel
Dekker Series, 1995.
3 Quality Assurance of Pharmaceuticals- A compedium of Guide lines and Related
materials Vol I & II, 2nd edition, WHO Publications, 1999.
4 How to Practice GMP’s – P P Sharma, Vandana Publications, Agra, 1991.
188
5 The International Pharmacopoeia – vol I, II, III, IV & V - General Methods of
Analysis and Quality specification for Pharmaceutical Substances, Excepients and
Dosage forms, 3rd edition, WHO, Geneva, 2005.
6 Good laboratory Practice Regulations – Allen F. Hirsch, Volume 38, Marcel Dekker
Series, 1989.
7 ICH guidelines
8 ISO 9000 and total quality management
9 The drugs and cosmetics act 1940 – Deshpande, Nilesh Gandhi, 4th edition, Susmit
Publishers, 2006.
10 QA Manual – D.H. Shah, 1st edition, Business Horizons, 2000.
11 Good Manufacturing Practices for Pharmaceuticals a plan for total quality control –
Sidney H. Willig, Vol. 52, 3rd edition, Marcel Dekker Series.
12 Steinborn L. GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their
Suppliers, Sixth Edition, (Volume 1 - With Checklists and Software Package). Taylor
& Francis; 2003.
13 Sarker DK. Quality Systems and Controls for Pharmaceuticals. John Wiley & Sons;
2008.
14 Packaging of Pharmaceuticals.
15 Schedule M and Schedule N.
189
PRODUCT DEVELOPMENT AND TECHNOLOGY TRANSFER (MQA103T)
Scope
This deal with technology transfer covers the activities associated with Drug
Substance, Drug Product and analytical tests and methods, required following candidate
drug selection to completion of technology transfer from R&D to the first receiving site
and technology transfer related to post-marketing changes in manufacturing places.
Objectives:
Upon completion of this course the student should be able to
To understand the new product development process
To understand the necessary information to transfer technology from R&D to
actual manufacturing by sorting out various information obtained during R&D
To elucidate necessary information to transfer technology of existing products
between various manufacturing places
THEORY 60 Hrs
1. Principles of Drug discovery and development: Introduction, Clinical research
process. Development and informational content for Investigational New Drugs
Application (IND), New Drug Application (NDA), Abbreviated New Drug
Application (ANDA), Supplemental New Drug Application (SNDA), Scale Up Post
Approval Changes (SUPAC) and Bulk active chemical Post approval changes
(BACPAC), Post marketing surveillance, Product registration guidelines – CDSCO,
USFDA.
12 Hrs
3. Pilot plant scale up: Concept, Significance, design, layout of pilot plant scale up
study, operations, large scale manufacturing techniques (formula, equipment, process,
stability and quality control) of solids, liquids, semisolid and parenteral dosage forms.
New era of drug products: opportunities and challenges.
12 Hrs
190
modern drug packaging, Selection and evaluation of Pharmaceutical packaging
materials.
Quality control test: Containers, closures and secondary packing materials.
12 Hrs
REFERENCES
1. The process of new drug discovery and development. I and II Edition (2006) by
Charles G. Smith, James T and O. Donnell. CRC Press, Group of Taylor and Francis.
2. Leon Lac Lachman, Herbert A. Liberman, Theory and Practice of Industrial Pharmacy.
Marcel Dekker Inc. New York.
3. Sidney H Willing, Murray M, Tuckerman. Williams Hitchings IV, Good
manufacturing of pharmaceuticals (A Plan for total quality control) 3rd Edition.
Bhalani publishing house Mumbai.
4. Tablets Vol. I, II, III by Leon Lachman, Herbert A. Liberman, Joseph B. Schwartz,
2nd Edn. (1989) Marcel Dekker Inc. New York.
5. Text book of Bio- Pharmaceutics and clinical Pharmacokinetics by Milo Gibaldi, 3rd
Edn, Lea & Febriger, Philadelphia.
6. Pharmaceutical product development. Vandana V. Patrevale. John I. Disouza.
Maharukh T.Rustomji. CRC Press, Group of Taylor and Francis.
7. Dissolution, Bioavailability and Bio-Equivalence by Abdou H.M, Mack Publishing
company, Eastern Pennsylvania.
8. Remingtons Pharmaceutical Sciences, by Alfonso & Gennaro, 19th Edn.(1995)OO2C
Lippincott; Williams and Wilkins A Wolters Kluwer Company, Philadelphia.
9. The Pharmaceutical Sciences; the Pharma Path way ‘Pure and applied Pharmacy’ by
D. A Sawant, Pragathi Books Pvt. Ltd.
10. Pharmaceutical Packaging technology by D.A. Dean. E.R. Evans, I.H. Hall. 1st
Edition(Reprint 2006). Taylor and Francis. London and New York.
191
QUALITY ASSURANCE PRACTICAL-I (MQA104P)
PRACTICALS
192
HAZARDS AND SAFETY MANAGEMENT (MPA201T)
Scope
Objectives
THEORY
60Hrs
12 Hrs
2. Air based hazards: Sources, Types of Hazards, Air circulation maintenance industry
for sterile area and non sterile area, Preliminary Hazard Analysis (PHA)
Fire protection system: Fire prevention, types of fire extinguishers and critical Hazard
management system.
12 Hrs
193
3. Chemical based hazards: Sources of chemical hazards, Hazards of Organic synthesis,
sulphonating hazard, Organic solvent hazard, Control measures for chemical hazards,
Management of combustible gases, Toxic gases and Oxygen displacing gases
management, Regulations for chemical hazard, Management of over-Exposure to
chemicals and TLV concept.
12 Hrs
REFERENCES:
1. Y.K. Sing, Environmental Science, New Age International Pvt, Publishers, Bangalore
2. “Quantitative Risk Assessment in Chemical Process Industries” American Institute of
Chemical Industries, Centre for Chemical Process safety.
3. Bharucha Erach, The Biodiversity of India, Mapin Pu blishing Pvt. Ltd., Ahmedabad –
380 013, India,
4. Hazardous Chemicals: Safety Management and Global Regulations, T.S.S. Dikshith,
CRC press
194
PHARMACEUTICAL VALIDATION (MQA202T)
Scope
The main purpose of the subject is to understand about validation and how it can be
applied to industry and thus improve the quality of the products. The subject covers the
complete information about validation, types, methodology and application.
Objectives
THEORY
60 Hrs
195
Qualification of analytical instruments: UV-Visible spectrophotometer, FTIR, DSC,
GC, HPLC, HPTLC, LC-MS.
12 Hrs
REFERENCES:
196
157,2nd Ed., Marcel Dekker Inc., N.Y.
6. Validation Standard Operating Procedures: A Step by Step Guide for Achieving
Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Syed
Imtiaz Haider
7. Pharmaceutical Equipment Validation: The Ultimate Qualification Handbook, Phillip
A. Cloud, Interpharm Press
8. Validation of Pharmaceutical Processes: Sterile Products, Frederick J. Carlton (Ed.)
and James Agalloco (Ed.), Marcel Dekker
9. Analytical Method validation and Instrument Performance Verification by Churg
Chan, Heiman Lam, Y.C. Lee, Yue. Zhang, Wiley Interscience.
10. Huber L. Validation and Qualification in Analytical Laboratories. Informa Healthcare
11. Wingate G. Validating Corporate Computer Systems: Good IT Practice for
Pharmaceutical Manufacturers. Interpharm Press
12. LeBlanc DA. Validated Cleaning Technologies for Pharmaceutical Manufacturing.
Interpharm Press
197
AUDITS AND REGULATORY COMPLIANCE (MPA203T)
Scope:
This course deals with the understanding and process for auditing in
pharmaceutical industries. This subject covers the methodology involved in the auditing
process of different in pharmaceutical industries.
Objectives:
THEORY
60 Hrs
198
Product and process information, General areas of interest in the building raw
materials, Water, Packaging materials.
12 Hrs
REFERENCES
1. Compliance auditing for Pharmaceutical Manufacturers. Karen Ginsbury and Gil
Bismuth, Interpharm/CRC, Boca Raton, London New York, Washington D.C.
2. Pharmaceutical Manufacturing Handbook, Regulations and Quality by Shayne Cox
Gad. Wiley-Interscience, A John Wiley and sons, Inc., Publications.
3. Handbook of microbiological Quality control. Rosamund M. Baird, Norman A.
Hodges, Stephen P. Denyar. CRC Press. 2000.
4. Laboratory auditing for quality and regulatory compliance. Donald C. Singer, Raluca-
loana Stefan, Jacobus F. Van Staden. Taylor and Francis (2005).
199
PHARMACEUTICAL MANUFACTURING TECHNOLOGY (MPA204T)
Scope
This course is designed to impart knowledge and skills necessary to train the
students with the industrial activities during Pharmaceutical Manufacturing.
Objectives
The common practice in the pharmaceutical industry developments, plant layout and
production planning
Will be familiar with the principles and practices of aseptic process technology, non
sterile manufacturing technology and packaging technology.
Have a better understanding of principles and implementation of Quality by design
(QbD) and process analytical technology (PAT) in pharmaceutical manufacturing
THEORY
60Hrs
200
Advanced sterile product manufacturing technology : Area planning &
environmental control, wall and floor treatment, fixtures and machineries, change
rooms, personnel flow, utilities & utilities equipment location, engineering and
maintenance.
Process Automation in Pharmaceutical Industry: With specific reference to
manufacturing of sterile semisolids, Small Volume Parenterals & Large Volume
Parenterals (SVP & LVP), Monitoring of Parenteral manufacturing facility, Cleaning
in Place (CIP), Sterilization in Place (SIP), Prefilled Syringe, Powdered Jet, Needle
Free Injections, and Form Fill Seal Technology (FFS).
Lyophilization technology: Principles, process, equipment.
12Hrs
201
worthiness of package, Stability aspects of packaging. Evaluation of stability of
packaging material.
1
2H
rs
REFERENCES
1. Lachman L, Lieberman HA, Kanig JL. The theory and practice of industrial pharmacy,
rd
3 ed., Varghese Publishers, Mumbai 1991.
th
2. Sinko PJ. Martin's physical pharmacy and pharmaceutical sciences, 5 ed., B.I.
Publications Pvt. Ltd, Noida, 2006.
3. Lieberman HA, Lachman L, Schwartz JB. Pharmaceutical dosage forms: tablets Vol. I-
nd
III, 2 ed., CBS Publishers & distributors, New Delhi, 2005.
th
4. Banker GS, Rhodes CT. Modern Pharmaceutics, 4 ed., Marcel Dekker Inc, New
York, 2005.
5. Sidney H Willing, Murray M, Tuckerman. Williams Hitchings IV, Good
manufacturing of pharmaceuticals (A Plan for total quality control) 3rd Edition.
Bhalani publishing house Mumbai.
6. Indian Pharmacopoeia. Controller of Publication. Delhi, 1996.
7. British Pharmacopoeia. British Pharmacopoeia Commission Office, London, 2008.
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