Industrial Pharmacy – II
This course is designed to impart fundamental knowledge of pharmaceutical product Commercialization from laboratory to market
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
UNIT – II
Technology development and transfer: WHO guidelines for Technology Transfer: Terminologies, Technology transfer protocol, Quality risk management, Transfer from R & D to production (Process, packaging and cleaning), Granularity of TT Process (API, excipients, finished products, packing 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), TOT agencies in India – APCTD, NRDC, TIFAC, BCIL, TBSE /
SIDBI; Technology of Transfer (TOT) related documentation – confidentiality agreements, licensing,MoUs, legal issues
UNIT – III
1. Regulatory affairs: Introduction, Historical overview of Regulatory Affairs, Regulatory authorities, Role of Regulatory affairs department, Responsibility of Regulatory Affairs Professionals
2. Regulatory requirements for drug approval: Drug Development Teams, Non-Clinical Drug Development, 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 Presentation for FDA Submissions, Management of Clinical Studies.
UNIT – IV
Quality management systems: Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by design, Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP
UNIT – V
Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Common Technical Document (CTD), Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs.