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Semester VIII · PCI syllabus 2026
Industrial Pharmacy and Facility Design
BP803T
3 credits
Theory
Coming soon
Unit 1: Regulatory guidelines for formulation Development:
- ICH Q8, QbD and optimization (Fundamental terminologies, process and applications) ICH guidelines of stability testing Industrial aspects of Product development Pilot Plant and Scale up: General considerations including significance 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 2: Technology development and transfer:
- WHO guidelines for Technology Transfer(TT): Terminology, Technology transfer protocol, Quality risk management, Transfer from R & D production (Process, packaging and cleaning), Granularity of TT Process (API, excipients, finished products, packaging materials) Documentation, Premises and equipments, qualification and validation, quality control and analytical method transfer. TT agencies in India - APCTD, NRDC, TIFAC, BCIL, TBSE / SIDBI; TT related documentation - confidentiality agreement, licensing, MoUs, legal issues
Unit 3: Facility Considerations: Non sterile
- Facility design according to schedule M for various dosage forms, Water purification system: design and operation, Storage, distribution, and validation of water systems. Different types of waters. Steam systems and Clean Steam, Compressed air, Vacuum, CIP. Industry standards for water and steam systems. Effluent testing facility: Design and significance. Layout design for various non- sterile dosage forms (Process flow) Cleaning and disinfection protocols, cleaning types (Type A, B and C), Cleaning validation methods and acceptance criteria,
Unit 4: Facility considerations: Sterile
- - Overview of sterile pharmaceutical manufacturing: layout as per schedule M and cGMP, clean room concept -Importance of sterility and contamination control, SIP. efficient material and personnel flow to maintain sterility, zoning and segregation, Guidelines, standards and Cleanroom classifications from FDA, EMA, WHO and ISO. - Heating, ventilation and air conditioning system (HVAC): Significance, components, testing (including efficiency and integrity testing of HEPA). - Parameters for qualification and validation (routine monitoring) clean area
Unit 5: Advances in facility design
- Modular concept of manufacturing facilities with significance and suitable isolators, Modular cleanrooms Automation and robotics in pharmaceutical manufacturing operations
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