I M. PHARM / QUALITY CONTROL AND QUALITY ASSURANCE – THEORY
After a successful completion of the course the students will be able to
| Course outcome number | Course Outcomes | Cognitive level |
| CO1 | Describe the documentation requirements in the pharmaceutical industry, including the three-tier documentation system, standard operating procedures, quality audit plans, and electronic data management. . | C1 |
| CO2 | Explain the concept and evolution of Quality Control and Quality Assurance in the pharmaceutical industry, including Good Laboratory Practices (GLP) and Good Manufacturing Practices and demonstrate the ability to perform the analysis of raw materials, finished products, and packaging materials in pharmaceutical manufacturing, and develop specifications following ICH Q6 and Q3 guidelines. | C2 |
| CO3 | Apply the knowledge acquired in the course to real-world pharmaceutical quality control and assurance scenarios, demonstrating the ability to make informed decisions and ensure compliance with industry standards and regulations. | C3 |
| CO4 | Analyze the key guidelines and regulations related to quality control and assurance, including ICH guidelines, GMP according to various standards, and CPCSEA guidelines. | C4 |
| CO5 | Evaluate the various aspects of quality control and assurance in pharmaceutical manufacturing, including quality audit reports, deviation handling, and change control procedures and examine manufacturing operations and controls in pharmaceutical production, covering topics such as sanitation, processing, packaging, quality control, and aseptic processes, ensuring compliance with relevant regulations. | C5 |
| CO6 | Create a visual representation, including charts, diagrams, and key features, illustrating concepts and processes related to Quality Control and Quality Assurance in the pharmaceutical industry, cGMP guidelines, analysis of pharmaceutical materials, documentation practices, and manufacturing operations and controls. | C6 |
Remembering (C1), Understanding (C2), Applying (C3), Analyzing (C4), Evaluating (C5) and Creating (C6)
