PY6003 - VALIDATION IN PHARMACEUTICAL INDUSTRIES (Syllabus) 2013-regulation Anna University

PY6003 - VALIDATION IN PHARMACEUTICAL INDUSTRIES (Syllabus) 2013-regulation Anna University

PY6003

VALIDATION IN PHARMACEUTICAL INDUSTRIES

 LPTC

3003

OBJECTIVES:
• To provide the information on GMP/GLP regulations involved in the manufacturing of API and biological products.
• To provide the importance of impurity profile and stability testing of drugs.

UNIT I

DRUGS AND COSMETICS ACT AND GMP FOR API

9

Drugs and cosmetics act -1948 – Organization and personnel – Buildings and facilities – Equipment – Documentation and records – Material management – Production and in process control – Packaging and labeling – Storage Distribution.

UNIT II

IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS

9

Quality USP description of impurities – Validation and impurity issue related to manufacturing – Processing of drug substances – Enantiomers as impurities – Polymorphs as unwanted components.


UNIT III

CLEANING FOR API MANUFACTURING FACILITIES

9

Regulatory requirements – Multiple vs dedicated equipment – Unique nature of API – Multiple level approach to cleaning – Nature of contaminants – Selection of a worst case – Cleaning techniques – Sampling – Analytical methods – Limits and acceptance criteria, documentation.

UNIT IV

STABILITY TESTING

9

Reasons for stability testing – Modes of degradation – Shelf lives and expiration dates – Possible strategies to improve shelf lives – Stability testing of new drug substances and products (Q1A) – Photo stability testing of new substances and products (Q1B) – Validation on analytical procedures (Q2A).

UNIT V

GMP FOR BIOLOGICAL PRODUCTS

9

Organization and personnel – Buildings and facilities – Equipment – Documentation – Production and in-process control – Packaging and labeling – Storage – Distribution – Disposal of bio medical waste.

TOTAL : 45 PERIODS

OUTCOMES: The student will be able to
• Determine the shelf-life, impurity profile and expiry date for the API and finished products through stability studies.
• Understand the role of cleanliness in manufacturing high purity products and reducing adverse products.
• Understand regulatory practices and administrative functions adopted in the pharmaceutical organizations.

TEXT BOOKS:
1. Ira, R.B. and Harpaz, D., “Validation of Active Pharmaceutical Ingredients”, 2nd Edition, CRC Press, 2001.
2. Anjaneyulu, Y. and Maraya, R., “Quality Assurance and Quality Management in Pharmaceutical Industry”, Pharma Book Syndicate, 2005.

REFERENCES:
1. Willig, S.H., “Good Manufacturing Practice for Pharmaceuticals”, 5th Edition, Marcel Dekker, 2005.
2. Iyer, S., “Guidelines on cGMP and Quality of Pharmaceutical Products”, 1st Edition, D.K.Publications, 2003.
3. Carstensen, J.T. and Rhodes, C.T., “Drug Stability Principles and Practice”, 3rd Edition,Marcel Dekker, 1995

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