DRA, INTELLECTUAL PROPERTY RIGHTS AND QUALITY ASSURANCE (MPY -103) SYLLABUS

DRA, INTELLECTUAL PROPERTY RIGHTS AND QUALITY ASSURANCE (MPY -103) SYLLABUS

Theory

1. Requirements of GMP, CGMP, GLP, USFDA, WHO guidelines and ISO 9000 Series.

2. Drugs and Cosmetics Acts and Rules, Drug Regulatory Affairs.

3. Documentation – Protocols, Forms and Maintenance of records in Pharmaceutical industry.

4. Clinical Trials and toxicological evaluation of drugs. Preparation of documents for New Drug Approval and Export Registration.

5. Processing and its application, Intellectual Property Rights (Patent, Copy right and Trade marks).

6. Sewage disposal and Pollution control.

7. Concepts in Validation, Validation of manufacturing, Analytical and Process validation and its Application.

8. Basic concept of Quality Control and Quality Assurance systems, Source and Control of Quality variation of Raw materials, Containers, Closures, Personnel, Environmental, etc.

9. In process quality control tests, IPQC problems in Pharmaceutical industries. ICH Guidelines

10. Sampling plans, Sampling and Characteristic curves.

11. Master formula generation and Maintenance, Standard Operating Procedure (SOP) for different dosage forms.

Books and References Recommended:

1. Willing, Tuckerman and Hitching, Good Manufacturing Practices for Pharmaceuticals.

2. Drugs and Cosmetic Acts and Rules.

3. Bharathi, Drugs and Pharmacy Laws in India.

4. Patel, Industrial Microbiology.

5. Loftus, B.T. and Nash,R.A., Pharmaceutical Process Validation.

6. Bolton, S., Pharmaceutical Statistics.

7. Banker, G.S. and Rhodes, C.T., Modern Pharmaceutics.

8. OPPI, Quality Assurance.

9. Carletiori, Validation of Aseptic Pharmaceutical Process.

10. Garfield, Quality Assurance Principles for Analytical Laboratories.

11. Indian Pharmacopoeia.

12. British Pharmacopoeia.

13. United State Pharmacopoeia.