UNIT I Pilot Plant Scale Up Techniques : General considerations - including significance of personnel requirements, space requirements, raw materials, Pilot plant scale up considerations for solids, liquid orals, semi solids and relevant documentation, SUPAC guidelines, Introduction to platform technology (Chapter - 1) UNIT II Technology Development and Transfer : WHO guidelines for Technology Transfer (T T) : 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 materials) 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 (Chapter - 2) UNIT III Regulatory Affairs : Introduction, Historical overview of Regulatory Affairs, Regulatory authorities, Role of Regulatory affairs department, Responsibility of Regulatory Affairs Professionals (Chapter - 3) UNIT IV Quality Management Systems : UNIT V Indian Regulatory Requirements :
