OPY752 Syllabus - Regulatory Requirements In Pharmaceutical Industries - 2017 Regulation - Open Elective | Anna University

OPY752 Syllabus - Regulatory Requirements In Pharmaceutical Industries - 2017 Regulation - Open Elective | Anna University

OPY752

REGULATORY REQUIREMENTS IN PHARMACEUTICAL INDUSTRIES

 L T P C

3003

OBJECTIVE:
• To acquire the knowledge of pharmaceutical industry regulations and research

UNIT I

REGULATORY CONCEPTS

9

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

UNIT II

REGULATORY ASPECTS

9

Pharmaceuticals: Bulk drug manufacture; Personnel, Buildings and Facilities, Process Equipment, Documentation and Records, Materials Management, Production and In-Process Controls, Packaging and Identification Labelling of API‟s and Intermediates, Storage and distribution, – Biotechnology derived products; Principles, Personnel, Premises and equipments, Animal quarters and care, production, labelling, Lot processing records and distribution records, quality assurance and quality control.


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) rules 2016.

UNIT IV

ICH GUIDELINES

9

Quality guidelines – Impurities in new drug substances (Q3A(R2)) – Impurities in newdrug products(Q3B(R2)) – 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: On completion of the course, the student will be able
• To be familiarise with the pharmaceutical industry manufacturing practices and regulatory aspects of pharmacy products.
• To know the process of patenting activities.
• To know the quality guidelines followed for pharmaceutical products and few of the aspects involved in document preparation for pharmaceutical product registration.

TEXT BOOKS:
1. C.V.SSubbrahmanyam & J.Thimmasetty, Pharmaceutical regulatory affairs, 1stEdn., vallabhPrakashan, New Delhi, 2012.
2. Willig, H., Tuckeman, M.M. and Hitchings, W.S., “Good Manufacturing Practices for Pharmaceuticals”, 5th Edition, Marcel Dekker Drugs and the Pharmaceutical Sciences, by CRC Press, New York, 2000.
3. N Udupa, Krishnamurthy Bhat, A Concise Textbook of Drug Regulatory Affairs, Manipal University Press (MUP); First Edition, 2015.

REFERENCES:
1. Ira R. Berry,The Pharmaceutical Regulatory Process, marcel dekker Series: Drugs and the Pharmaceutical Sciences, by CRC Press, Newyork, 2004.
2. Mindy J. Allport-Settle, Current Good Manufacturing Practices: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference, Pharmalogika Inc., USA, 2009.
3. Sharma, P.P., “How to Practice GMPs”, 3rd Edition, Vandana Publications, 2006.

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