BO4101 Drug Regulatory, Quality and Safety Management Syllabus:
BO4101 Drug Regulatory, Quality and Safety Management Syllabus – Anna University PG Syllabus Regulation 2021
COURSE OBJECTIVES:
The course aims to,
Enable the students to learn about the various agencies in drug regulatory affairs in India and at International level.
Acquire knowledge about intellectual property rights, drug development approval processes and safety management.
UNIT I INTRODUCTION TO DRUG REGULATORY LAWS
Drugs and Cosmetics Act 1940 with its amendments, The Drugs (Price Control) Order 2013 with its amendments, The Environmental Protection Act-1986 with its amendments, Consumer Protection Act-2019, The Factories (amendment) Act-1987 and Pollution control Act-1989, The Indian Patents and Designs, Act 1911, The Grugs and Magic Remedies (Objectionable advertisements) Act 1954, Prevention of Food Adulteration Act 1954, Guidelines for evaluation of nano pharmaceuticals in India
UNIT II PHARMACOPOEIA
Descriptions & Monographs; Standards and Specifications; Testing of Drugs; Various Countries Pharmacopoeias; Indian, British, U.S, European, Japanese and International pharmacopoeia.
UNIT III cGMPs & REGULATORY RECORDS
cGMP concepts – Development, Manufacturing Record, Analytical &process Validation, Equipment & utility Qualification and Calibration, Personnel procedures; Regulatory bodies &requirements – Indian FDA, WHO GMP ; U.S. FDA, U.K. MCA, Australian TGA, Japanese PMDA. Drug dossier contents – CTD (CMC section) & data.
UNIT IV DRUG DEVELOPMENT APPROVAL PROCESS/CLINICAL TRIALS
Drug development stages, FDA guidelines on IND, NDA, ANDA approvals. European regulatory agency: types of filing process (Centralized, decentralized, RMS countries), Regulation of preclinical studies, Schedule-Y, pre-clinical study; Introduction to animal ethics; Animal rights and use of animals in the advancement of medical technology; Introduction to laws and regulations regarding the use of animals in research.
UNIT V PRODUCT MANAGEMENT AND QUALITY ASSURANCE
GLP, ISO 9000, TQM, Quality Review and Quality Documentation, Regulatory control, regulatory drug analysis, interpretation of analytical data, Basic requirements – design of product, facility, equipment selection and personnel. Industrial hazards due to fire, accident, mechanical, electrical equipment, monitoring and preventive system (Safety measures including insurance).Effluent testing, treatment and waste management. Safety and Environmental Control; ISO 14000.
TOTAL:45 PERIODS
COURSE OUTCOMES:
At the end of the course the student will be able to,
CO1 Enable the students to learn the principles of drug regulation.
CO2 Insight about current regulatory process in the pharmaceutical industry.
CO3 Assure the learning of quality standards in pharmaceutical industry.
REFERENCES:
1. N Udupa and Krishnamurthy Bhat. A Concise Textbook of Drug Regulatory Affairs , Manipal University Press, Edition: 1, 2015.
2. Manohar A. Potdar and Ramkumar Dubey. cGMP Current Good Manufacturing Practices for Pharmaceuticals, Pharmamed Press / Bsp Books, Second Edition, 2018.
3. Abraham, John and Smith, H.W. “Regulation of the Pharmaceutical Industry”, Palgrave, Macmillan, 2003.
4. Weinberg, Sandy “Good Laboratory Practice Regulations” 4th Edition, Marcel Dekker,2007.
5. Gad, Shayne C. “Drug Safety Evaluation”, Wiley-Interscience, 3rd Edition, 2016.
6. Malik, Vijay “Laws Relating to Drugs and Cosmetics Act & Rules”. EBC Publishing Co, 2018.
7. “Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials”, Vol. I & II, World Health Organization and Pharma Syndicate, 2002.
8. Berry, Ira R. and Harpaz, Daniel “Validation of Active Pharmaceutical Ingredients”, 2nd Edition, CRC Press, 2001
9. British Pharmacopoeia, Andesite Press, 2021.
10. United States Pharmacopoeia, 2020
11. https://cdsco.gov.in/opencms/opencms/en/Home/
12. https://pharmaceuticals.gov.in/