SYLLABUS
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, semisolids and
relevant documentation. SUPAC guidelines, Introduction to platform technology.
Unit-II
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 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.
Unit-III
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 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 (QbD), Six Sigma Concept, Out of Specifications (OOS), Change Control,
Introduction to ISO 9000 series of quality system standards, ISO 14000, NABL, GLP.
Unit-V
Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State
Licensing Authority: Organization, responsibilities, Certificate of Pharmaceutical Product (COPP), regulatory
requirements and approval procedures for new drugs.
