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AKTU Industrial Pharmacy and Facility Design (Theory) (BP803T) Syllabus PDF – B.Pharm 8th Semester
Industrial Pharmacy and Facility Design (Theory) BP803T
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Official AKTU syllabus of Industrial Pharmacy and Facility Design (Theory) (BP803T) for B.Pharm 8th Semester – 3 credits, L-T-P 3-0-0. Read the unit-wise course content, course outcomes, evaluation pattern and recommended books online, or download the PDF.
Syllabus — Industrial Pharmacy and Facility Design (Theory)
Download PDFBP803T · 3 credits · L-T-P 3-0-0
Course Objectives
- Introduce regulatory guidelines such as ICH, WHO, Schedule M, cGMP, and SUPAC governing pharmaceutical formulation development, stability testing, and scale-up processes.
- Develop an understanding of industrial product development processes including pilot plant operations, scale-up considerations, and platform technologies used in pharmaceutical manufacturing.
- Explain the principles and procedures involved in technology transfer from research and development to commercial production, including documentation, quality risk management, and regulatory compliance.
- Introduce the design and operational requirements of pharmaceutical facilities for sterile and non-sterile manufacturing, including layout planning, utilities, and contamination control systems.
- Familiarize students with modern pharmaceutical facility design concepts such as modular cleanrooms, isolators, automation, and advanced contamination control technologies to ensure product quality and regulatory compliance.
Course Outcomes
| CO | Upon successful completion of this course, the students will be able to: |
| No. | |
| 1 | Interpret regulatory guidelines (ICH, WHO, Schedule M, SUPAC) relevant to pharmaceutical product development, stability studies, and manufacturing processes. |
| 2 | Explain pilot plant operations and scale-up strategies for the development of solid, liquid, and semi-solid pharmaceutical dosage forms. |
| 3 | Describe the processes, documentation, and quality management principles involved in technology transfer from R&D to manufacturing. |
| 4 | Design and evaluate facility layouts and utility systems for sterile and non-sterile pharmaceutical manufacturing in accordance with cGMP and global cleanroom standards. |
| 5 | Assess modern pharmaceutical facility design approaches, including modular cleanrooms, automation, and validation systems, to ensure efficient and compliant manufacturing operation |
Course Content
| Unit | Topics | No. of |
|---|---|---|
| I | 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 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 | 12 hours |
| 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 and analytical method transfer. TT agencies in India - APCTD, NRDC, TIFAC, BCIL, TBSE / SIDBI; TT related documentation - confidentiality agreement, licensing, MoUs, legal issues | 9 hours |
| III | 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, | 9 hours |
| IV | 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) of clean area. | 9 hours |
| V | Advances in facility design Modular concept of manufacturing facilities with significance and suitable examples, Advances in clean room technology: pass- through chambers, isolators, Modular cleanrooms Automation and robotics in pharmaceutical manufacturing operations. | 6 hours |
Recommended References
- Akers, M. J. Sterile Product Development: Formulation, Process and Regulatory Considerations. CRC Press.
- Beg, S., Abbas, M. Z. and Hossain, M. A. Pharmaceutical Quality by Design: A Practical Approach. Academic Press.
- Bunn, G. Pharmaceutical Production Facilities: Design and Applications. CRC Press.
- Francke, R. M. and Meissner, H. Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing. CRC Press.
- Gad, S. C. Pharmaceutical Manufacturing Handbook: Production and Processes. Wiley.
- Levin, M. Pharmaceutical Process Scale-Up. CRC Press.
- McCormick, K. Pharmaceutical Facility Design. CRC Press.
- Nally, J. D. Good Manufacturing Practices for Pharmaceuticals. CRC Press.
- Sandle, T. Advanced Cleanroom Technology. Wiley-Blackwell.
- Steinborn, L. GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers. CRC Press.
- Teasdale, A., Elder, D. and Greenwood, R. W. ICH Quality Guidelines: An Implementation Guide. Wiley.
- Whyte, W. Cleanroom Technology: Fundamentals of Design, Testing and Operation. Wiley-Blackwell.
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