Industrial Pharmacy and Facility Design (Theory)

• The objectives of this course are to:
• 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.

After completion of the course student will be able to:

1. CO1Interpret regulatory guidelines (ICH, WHO, Schedule M, SUPAC) relevant to pharmaceutical product development, stability studies, and manufacturing processes.
2. CO2Explain pilot plant operations and scale-up strategies for the development of solid, liquid, and semi-solid pharmaceutical dosage forms.
3. CO3Describe the processes, documentation, and quality management principles involved in technology transfer from R&D to manufacturing.
4. CO4Design and evaluate facility layouts and utility systems for sterile and non-sterile pharmaceutical manufacturing in accordance with cGMP and global cleanroom standards.
5. CO5Assess modern pharmaceutical facility design approaches, including modular cleanrooms, automation, and validation systems, to ensure efficient and compliant manufacturing operation

1. Akers, M. J. Sterile Product Development: Formulation, Process and Regulatory Considerations. CRC Press.
2. Beg, S., Abbas, M. Z. and Hossain, M. A. Pharmaceutical Quality by Design: A Practical Approach. Academic Press.
3. Bunn, G. Pharmaceutical Production Facilities: Design and Applications. CRC Press.
4. Francke, R. M. and Meissner, H. Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing. CRC Press.
5. Gad, S. C. Pharmaceutical Manufacturing Handbook: Production and Processes. Wiley.
6. Levin, M. Pharmaceutical Process Scale-Up. CRC Press.
7. McCormick, K. Pharmaceutical Facility Design. CRC Press.
8. Nally, J. D. Good Manufacturing Practices for Pharmaceuticals. CRC Press.
9. Sandle, T. Advanced Cleanroom Technology. Wiley-Blackwell.
10. Steinborn, L. GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers. CRC Press.
11. Teasdale, A., Elder, D. and Greenwood, R. W. ICH Quality Guidelines: An Implementation Guide. Wiley.
12. Whyte, W. Cleanroom Technology: Fundamentals of Design, Testing and Operation. Wiley-Blackwell. Course Title Course Type