Quality Control and Quality Assurance-Sem I-QA

SVKM’s Narsee Monjee Institute of Management Studies
Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, Mumbai

School of Pharmacy & Technology Management, Shirpur
Program: M. Pharm (Pharmaceutical Quality Assurance) Semester : I
Course : Quality Control and Quality Assurance Code: MQA 103T

Teaching Scheme Evaluation Scheme
Lecture Practical Tutorial Credit Internal Term End
(Hours (Hours (Hours per Continuous Examinations (TEE)
per week) per week) Assessment (ICA) (Marks- 75 in
week) (Marks - 25 ) Question Paper)
4 0 0 4 Marks Scaled to 25 Marks Scaled to 75
Pre-requisite: Basic understanding of pharmaceutical testing and documentation
Objectives: This course deals with the various aspects of quality control and quality
Assurance aspects of pharmaceutical industries.
Outcomes:
After completion of the course, students will be able to :
1. Understand the aspects of cGMP and the responsibilities of QA & QC departments in
the pharmaceutical industry.
2. Analyse the significance of documentation.
3. Apply the quality certifications and regulatory requirements, applicable to
pharmaceutical industries.
4. Evaluate in process quality control and finished products quality control test for
dosage forms in Pharma industry.
Detailed Syllabus: ( per session plan )
Unit Description Duration
in hours
1 Introduction: Concept and evolution and scopes of Quality Control and 12
Quality Assurance, GMP, Overview of ICH Guidelines - QSEM, with
special emphasis on Q series guidelines.)
Good Laboratory Practices: Scope and concept of GLP, Definitions,
Quality assurance unit, protocol for conduct of non-clinical testing,
control on animal house, report preparation and documentation. 21 CFR
Part 58, CPCSEA guidelines. Introduction to Organization for Economic
Co-operation and Development (OECD guidelines)
2 cGMP guidelines according to schedule M, USFDA (inclusive of CDER 12
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 and Good Warehousing Practice.
3 Analysis of raw materials, finished products, packaging materials, in process 12

quality control (IPQC), Developing specification, 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).
4 Documentation in pharmaceutical industry: Three tier documentation, 12
Policy, Procedures and Work instructions, and records (Formats), Basic
principles- How to maintain, retention and retrieval etc.
Standard operating procedures (How to write) Master Batch Record, Batch
Manufacturing Record, Quality audit plan and reports, Specification and test
procedures, Protocols and reports, Distribution records, Training record.
Electronic data handling. Concepts of controlled and uncontrolled
documents.
Submission documents for regulators: DMFs, Common Technical
Document and Electronic Common Technical Documentation (CTD, eCTD).
Concept of regulated and non-regulated markets.
5 Manufacturing operations and controls: Sanitation of manufacturing 12
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, expiry date calculation, calculation of yields,
production record review, change control, sterile products, aseptic process
control, packaging, reprocessing, salvaging, handling of waste and scrap
disposal. PAT guidance, standards and regulatory requirements.
Total 60
Text Books:
1. Good Laboratory Practice Regulations, 3rd Edition, 2005, Sandy Weinberg Vol. 69,
Marcel Dekker SeriesHow to Practice GMP’s – P P Sharma, Vandana Publications,
Agra, 7 th edition 2015.
2. The International Pharmacopoeia 2 0 2 0 – vol I, II, III, IV & V – General Methods
of Analysis and Quality specification for Pharmaceutical Substances, Excepients
and Dosage forms, 10 th edition WHO, Geneva,2020
3. The drugs and cosmetics act 1940 – Deshpande, Nilesh Gandhi, 10th edition, Susmit
Publishers, 2020.
Reference Books:
1. Willig S H, Good Manufacturing Practices for Pharmaceuticals a plan for total quality
control, Vol. 52, 5th edition, Marcel Dekker Series, 2005.
2. Sarker D K, Quality Systems and Controls for Pharmaceuticals. John Wiley& Sons; 2008.
Any other information:
Total Marks of Internal Continuous Assessment (ICA): 25 MarksDistribution of ICA

Marks :
Description of ICA Marks

Sessional examination 15
Term work 10
Total Marks : 25
____________ ____________
Signature Signature
(Prepared by) (Approved by)
Dr. Vaishali Londhe Dr. Bala Prabhakar
Chairperson Dean, SPPSPTM

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SVKM’s Narsee Monjee Institute of Management Studies

Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, Mumbai

Program: M. Pharm (Pharmaceutical Quality Assurance) Semester : I

Course : Quality Control and Quality Assurance Code: MQA 103T

3 Analysis of raw materials, finished products, packaging materials, in process 12

Any other information:

Total Marks of Internal Continuous Assessment (ICA): 25 MarksDistribution of ICA

Description of ICA Marks

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