PY6503 - REGULATORY REQUIREMENTS IN PHARMACEUTICAL INDUSTRIES (Syllabus) 2013-regulation Anna University

PY6503 - REGULATORY REQUIREMENTS IN PHARMACEUTICAL INDUSTRIES (Syllabus) 2013-regulation Anna University

PY6503

REGULATORY REQUIREMENTS IN PHARMACEUTICAL INDUSTRIES

 LPTC

3003

OBJECTIVE:
To provide the concept of the pharmaceutical industrial manufacturing practices, quality attributes of pharmacy products and patenting activities.

UNIT I

REGULATORY CONCEPTS

9

Quality assurance – Quality control – Practice of cGMP – Schedule M – USFDA.

UNIT II

REGULATORY ASPECTS

9

Pharmaceuticals – Bulk drug manufacture – Biotechnology derived products.


UNIT III

INTELLECTUAL PROPERTY RIGHTS

9

Patent system – Different types of patents – Filing process of application for patent – infringement of patents – The patent rules 2003 as amended by the patents (amendment) rule 2006.

UNIT IV

ICH GUIDELINES

9

Quality guidelines – Impurities in new drug substances (Q3A R) – Impurities in new drug products – Validation of analytical procedures text and methodology (Q2 R1).

UNIT V

QUALITY AUDIT AND SELF INSPECTIONS

9

SOPs – Documentation – Loan license auditing – Common technical documentation (CTD) – Drug master file (DMF).

TOTAL : 45 PERIODS

OUTCOMES: The student will
• Familiarise with the pharmaceutical industrial manufacturing practices, quality attributes of pharmacy products, patenting activities, etc.,
• Uderstand the various quality guidelines of pharmaceutical products, patenting activities and the significance of its documentation.

TEXT BOOKS:
1. Robert, I.R., Nash, R.A., Wachter, A.H. and Swarbrick, J., “Pharmaceutical Process Validation”, 3rd Edition, Maarcel Dekker Inc., 2003.
2. Willig, H., Tuckeman, M.M. and Hitchings, W.S., “Good Manufacturing Practices for Pharmaceuticals”, 5th Edition, Marcel Dekker Inc., 2000.

REFERENCES:
1. Subbaram, N.R., “What Everyone Should Know About Patents”, 2nd Edition,Pharma Book Syndicate, 2005.
2. Banker, G.S. and Rhodes, C.T., “Modern Pharmaceutics”, 4th Edition, Marcel Dekker Inc., 2002.
3. Narendra kumar jain, Pharmaceutical Product Development, CBS Publishers & Distributors, 2006.

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