Unit-1
Pilot Plant Scale Techniques
General considerations include the significance of the personnel requirements, Raw materials, Space requirements, Pilot plant scale-up consideration for liquids orals, solids, semi-solids, related documentation, SUPAC guidelines, and Introduction to platform technology.
Unit-2
Technology Development and Transfer
WHO guidelines for Technology Transfer (TT)- Technology transfer protocol, Terminology, Quality risk management, Transfer from R and D production (Cleaning, Process, and Packaging), Granularity of Technology Transfer process (API, finished products, excipients, and packaging materials), Documentation, Premises and equipment, Quality control.
Qualifications and validation, Analytical method transfer, Commercialisation of practical aspects and problems (case study), Approved regulatory bodies and agencies, Technology Transfer agencies in India- APCTD, TIFAC, NRDC, BCIL, TBSE, SIDBI, Technology Transfer related documentation- confidential agreement, MoUs, licensing, and legal issues.
Unit-3
• Regulatory Affairs
Introduction, Regulatory authorities, Historical overview of Regulatory affairs, Role of the Regulatory Affairs department, Responsibilities of Regulatory affairs professional.
• Regulatory requirements for the drug’s approval
Drug Development Teams, Pharmacology, Non-clinical Drug Development, Drug Metabolism and Toxicology, General Consideration of IND (Investigational New Drug) Applications, Investigators Brochure (IB).
New Drugs Application (NDA), Clinical Research or BE studies, Clinical Research Protocol, Data Presentation for FDA submission, Biostatistics in Pharmaceutical Product Development, and Management of Clinical Studies.
Unit-4
• Quality Management Systems
Quality management and certifications, Concepts of Quality, Total Quality Management (TQM), Quality by Design, Six Sigma concepts, Out of specifications, Change control, Introduction to ISO 9000 series of quality system standards, NABL, GLP, and ISO 14000.
Unit-5
• Indian Regulatory Requirements
Central Drug Standard Control Organisation, and State Licencing Authority- Organisation, Responsibility, Certifications Pharmaceutical Products, Regulatory requirements, and Approval procedure for the New Drugs
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