M. Pharm. (Quality Assurance) 1st Sem. Dr.

Shyam Sunder Pancholi

MQA 103T-Quality Control and Professor
Department of Pharmaceutics
Quality Assurance ISF College of Pharmacy
(An Autonomous College),Moga
Introduction E mail: sspancholi@isfcp.org
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 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.

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 Objectives

The course aims and objectives include:

• Knowledge about the cGMP aspects in a pharmaceutical industry and relevant

documentation

• Appreciation of the scope of quality certifications applicable to pharmaceutical

industry

• Knowledge of the responsibilities of QA & QC department

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 Course Outcomes

Upon completion of this course, it is expected that you are able to-

• understand the cGMP aspects in a pharmaceutical industry

• appreciate the importance of documentation

• understand the scope of quality certifications applicable to pharmaceutical industry

• understand the responsibilities of QA & QC department

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 Teaching- Learning Process

Total Modules : 05

Total Lectures : 50

Revision Lecture : 05

Old Paper Discussion : 05

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 Literature

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 Literature
1. Quality assurance guide by organization of pharmaceutical procedures of India,
Volume I & II, Mumbai, OPPI Quality Summit 2018.
2. Good laboratory practice regulations, Sandy Weinberg Vol. 69, Marcel Dekker
series 2002.
3. Quality assurance of pharmaceuticals- A compendium of guidelines and related
materials vol II, 2nd edition, 2007 Good manufacturing practices, WHO
publications.
4. How to practice GMP’s – P P Sharma, 7th edition, 2015, Vandana publications,
Agra.
5. The International Pharmacopoeia – Vol I, II, III, IV & V - General methods of
analysis and quality specification for pharmaceutical substances, excipients and
dosage forms, WHO, Geneva.
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 Literature
6. The drugs and cosmetics act 1940 – Deshpande, Nilesh Gandhi, 8th edition 2015,
Susmit Publishers.
7. QA Manual – D.H. Shah, 1st edition 2002, Business Horizons.
8. Good manufacturing practices for pharmaceuticals a plan for total quality control
– Sidney H. Willig, Vol. 52, 3rd Revision 1991, Marcel Dekker Inc.
9. ICH guidelines https://www.ich.org/page/quality-guidelines
10. ISO 9000 and total quality management https://www.iso.org/home.html
11. Schedule M, https://www.pharmaguideline.com/2010/10/schedule-m.html
12. https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/
acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf

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INTERNET SOURCES
• www.ich.org
• www.fda.gov
• europa.eu/index_en.htm
• https://www.tga.gov.au/tga-basics

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 Lecture Plan
Module -1 10 lectures
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

Lecture-1 Concept of Quality-Evolution and Scope of QC & QA

Lecture-2 GLP & GMP
Lecture-3 Overview of ICH Guidelines-QSEM
Lecture-4 ICH Q-Series Guidelines (Part 1)
Lecture-5 ICH Q-Series Guidelines (Part 2)
Lecture-6 Scope of GLP & Definitions,
Lecture-7 Quality Assurance Unit, Disqualification and reinstatement
Lecture-8 GLP-Conduct of Nonclinical Testing, Report Preparation & Documentation
Lecture-9 Animal House Control
Lecture-10 CPSCEA Guidelines

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 Lecture Plan
Module -2 10 lectures
cGMP guidelines according to schedule M, USFDA (inclusive of CDER and CBER), Pharmaceutical Inspection
Convention(PIC), WHO and EMEA covering: Organization and personnel responsibilities, training, hygiene and personal
records, drug industry location, design, construction and plant lay out, maintenance, sanitation, environmental control,
utilities and maintenance of sterile areas, Control of contamination, Good Warehousing Practice

Lecture-11 Schedule M, USFDA (inclusive of CDER and CBER), Pharmaceutical Inspection Convention(PIC), WHO
and EMEA
Lecture-12 cGMP Guidelines: General
Lecture-13 Organization and Personnel Responsibilities
Lecture-14 Training, Hygiene and Personal Records
Lecture-15 Drug Industry Location, Design, Construction and Plant Lay Out
Lecture-16 Maintenance & Sanitation
Lecture-17 Environmental Control, Utilities and Maintenance of Sterile Areas
Lecture-18 Control of Contamination, Good Warehousing Practice
Lecture-19 Revision
Lecture-20 Old Question Papers Discussion

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 Lecture Plan
Module -3 10 lectures
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)

Lecture-21 Analysis of Raw Materials, Finished Products, Packaging Materials

Lecture-22 Developing Specification (ICH Q6 and Q3)
Lecture-23 Purchase Specifications & Maintenance of Stores for Raw Materials
Lecture-24 In Process Quality Control (IPQC) & Finished Goods Quality Control Tablets & Capsules
Lecture-25 In Process Quality Control (IPQC) & Finished Goods Quality Control Ointments, Creams,
Suppositories
Lecture-26 In Process Quality Control (IPQC) & Finished Goods Quality Control Parenteral, Ophthalmic
Lecture-27 In Process Quality Control (IPQC) & Finished Goods Quality Control Surgical Products
Lecture-28 How to Refer Pharmacopoeias
Lecture-29 Revision
Lecture-30 Old Question Papers Discussion
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 Lecture Plan
Module –4 10 lectures
Quality audit plan and reports, Specification and test procedures, Protocols and reports, Distribution Records
Electronic data handling
Concepts of controlled and uncontrolled documents, Submission documents for regulators DMFs, as Common
Technical Document and Electronic Common Technical Documentation (CTD, eCTD)
Concept of regulated and non regulated markets
Lecture-31 Quality audit plan and reports
Lecture-32 Specification and test procedures,
Lecture-33 Protocols and reports, Distribution Records
Lecture-34 Electronic data handling
Lecture-35 Concepts of controlled and uncontrolled documents
Lecture-36 Submission documents for regulators DMFs
Lecture-37 Common Technical Document and Electronic Common Technical Documentation (CTD, eCTD)
Lecture-38 Concept of regulated and non regulated markets
Lecture-39 Revision
Lecture-40 Old Question Papers Discussion

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 Lecture Plan
Module –5 10 lectures
Manufacturing Operations and Controls, Sanitation of manufacturing premises, mix-ups and cross contamination,
Processing of intermediates and bulk products, Packaging operations, IPQC, Release of finished product, process
deviations, charge-in of components, Time limitations on production, drug product inspection, Introduction,
scope and importance of intellectual property rights
Lecture-41 Manufacturing Operations and Controls, Sanitation of Manufacturing Premises
Lecture-42 Mix-ups and Cross Contamination
Lecture-43 Processing of Intermediates and Bulk Products
Lecture-44 IPQC, Release of Finished Product
Lecture-45 Process Deviations, Charge-in of Components
Lecture-46 Time Limitations on Production
Lecture-47 Drug Product Inspection
Lecture-48 Introduction, Scope and Importance of Intellectual Property Rights
Lecture-49 Revision
Lecture-50 Old Question Papers Discussion

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 THANKS
For Further Detail/Suggestions
Please Contact

ISF COLLEGE OF PHARMACY, MOGA

(An Autonomous College)
Ghal Kalan, GT Road, Moga- 142001, (Pb.)
E- mail: director@isfcp.org
Website: www.isfcp.org

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