VI SEM-B.PHARM
PHARMACEUTICAL QUALITY ASSURANCE (Theory)
After a successful completion of the course the students will be able to
| Course outcome number | Course Outcomes | Cognitive level |
| CO1 | Recall and define key concepts related to quality assurance and quality management in the pharmaceutical industry. They will remember the definitions and principles of Quality Control, Good Laboratory Practices (GLP), ISO standards, and NABL accreditation. | C1 |
| CO2 | Understanding of the underlying concepts and principles of pharmaceutical quality management. They will comprehend the elements of Total Quality Management (TQM), ICH Guidelines, Quality by Design (QbD), and the importance of ISO 9000 and ISO 14000 standards. | C2 |
| CO3 | Apply their knowledge to real-world scenarios in the pharmaceutical industry. They will apply quality control tests for containers and packing materials, implement Good Laboratory Practices, and apply principles of calibration and validation in analytical methods. | C3 |
| CO4 | Analyze pharmaceutical processes and practices critically. They will analyze the organization and personnel responsibilities, facility design and maintenance, equipment selection and maintenance, and the handling of complaints and product recalls. | C4 |
| CO5 | Evaluate the quality documentation and audit processes in the pharmaceutical industry. They will assess the importance of quality review, document maintenance, and distribution records in ensuring product quality and regulatory compliance. | C5 |
| CO6 | Create a design quality assurance and management systems for pharmaceutical operations. They will create validation master plans and apply principles of good warehousing practice and materials management to ensure the quality and safety of pharmaceutical products. | C6 |
Remembering (C1), Understanding (C2), Applying (C3), Analyzing (C4), Evaluating (C5) and Creating (C6)
