Unit I (10 Hours)
Pilot plant scale up techniques: General considerations - including significance of personnel require- ments, space requirements, raw materials, Pilot plant scale up considerations for solids, liquid orals, semi solids and relevant documentation, SUPAC guidelines, Introduction to platform technology
Unit II (10 Hours)
Technology development and transfer: WHO guidelines for Technology Transfer(TT): Terminology, Technology transfer protocol, Quality risk management, Transfer from R & D to production (Process, packaging and cleaning), Granularity of TT Process (API, excipients, finished products, packaging mate- rials) Documentation, Premises and equipments, qualification and validation, quality control, analytical method transfer, Approved regulatory bodies and agencies, Commercialization - practical aspects and problems (case studies), TT agencies in India - APCTD, NRDC, TIFAC, BCIL, TBSE / SIDBI; TT related documentation - confidentiality agreement, licensing, MoUs, legal issues
Unit III (10 Hours)
Regulatory affairs: Introduction, Historical overview of Regulatory Affairs, Regulatory authorities, Role of Regulatory affairs department, Responsibility of Regulatory Affairs Professionals
Regulatory requirements for drug approval: Drug Development Teams, Non-Clinical Drug Develop- ment, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Pre- sentation for FDA Submissions, Management of Clinical Studies.
Unit IV (08 Hours)
Quality management systems: - Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP
Unit V (07 Hours)
Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State Li- censing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regula- tory requirements and approval procedures for New Drugs. Recommended Books: (Latest Editions)
- Regulatory Affairs from Wikipedia, the free encyclopedia modified on 7th April available at http,// en.wikipedia.org/wiki/Regulatory_ Affairs.
- International Regulatory Affairs Updates, 2005. available at http://www.iraup.com/about.php
- Douglas J Pisano and David S. Mantus. Text book of FDA Regulatory Affairs A Guide for Prescription Drugs, Medical Devices, and Biologics’ Second Edition.
- Regulatory Affairs brought by learning plus, inc. available at http.//www.cgmp.com/ra.htm.