I M. PHARM / PHARMACEUTICAL VALIDATION – THEORY
After a successful completion of the course the students will be able to
| Course outcome number | Course Outcomes | Cognitive level |
| CO1 | Understand the complexities of computerized system validation, particularly in the context of electronic records and digital significance, as regulated by 21 CFR Part 11 and GAMP 5. | C1 |
| CO2 | Explain the principles of analytical method validation, adhering to guidelines provided by ICH and USP, to ensure the accuracy, reliability, and suitability of methods used in pharmaceutical analysis and the concepts of qualification and validation, emphasizing their advantages and the importance of streamlining the qualification and validation process in the pharmaceutical industry. | C2 |
| CO3 | Demonstrate a deep understanding of pharmaceutical equipment qualification, including the development of User Requirement Specifications, Design Qualification, Factory/Site Acceptance Tests, Installation Qualification, Operational Qualification, and Performance Qualification. | C3 |
| CO4 | Qualify analytical instruments and glassware commonly used in pharmaceutical analysis, such as electronic balances, pH meters, spectrophotometers, chromatographs, and various glassware items, ensuring their precision and accuracy. | C4 |
| CO5 | Validate utility systems crucial to pharmaceutical manufacturing, such as pharmaceutical water systems, HVAC systems, compressed air, and nitrogen, as well as implement cleaning validation procedures for equipment and facilities. | C5 |
| CO6 | Create analytical methods for evaluating pharmaceutical processes and products through the design and execution of experiments in pharmaceutical validation. | C6 |
Remembering (C1), Understanding (C2), Applying (C3), Analyzing (C4), Evaluating (C5) and Creating (C6)
