- Degree Bachelor
- Code: PD513
- Credit hrs: 1
- Prequisites: PD117
This course involves the principles of the Current Good Manufacturing Practices (cGMP). It exposes students to all aspects of validation, calibration, inspection and the requirements for manufacturing facilities. It also provides students with a review of the process engineering, technology transfer, personnel management, training and hygiene, premises and contamination control, documentation and auditing, process deviation with emphasis on risk management, complaint handling and product recall theory.
Bachelor of Pharmacy - PharmD
1.1 Describe the importance of quality management, validation, documentation, facilities, equipment maintenance & environmental monitoring in maintaining GMP compliance.
1.2 Identify the role of GMP in the lifecycle of pharmaceutical products, from development to distribution.
1.3 Recognize the golden rules of Good Manufacturing Practice.
2.1 Recognize the ethical implications of GMP in ensuring the safety, quality, and efficacy of pharmaceutical products in addition to the strategy of audit.
2.2 Assess the personnel responsibilities for adhering to GMP regulations and the consequences of non-compliance with the organization's guidelines.
2.3 .Demonstrate the role of Statistical Process Control (SPC) in ensuring quality management through the ethical application of Measurement System Analysis (MSA), capability indices, and control charts to uphold GMP standards.
2.4 Comply with procedures to manage risk and improve safety in the manufacturing process
4.1 Use contemporary technologies and media to demonstrate effective presentation skills.
4.2 Promote lifelong learning and staying updated with advancements and changes in GMP standards and practices.
Bunn, Graham P., ed. Good Manufacturing Practices for Pharmaceuticals. CRC Press, 2019. Rodríguez-Pérez, José. Quality Risk Management in the FDA-Regulated Industry. Quality Press, 2017. Teasdale, Andrew, David Elder, and Raymond W. Nims, eds. ICH Quality Guidelines: An Implementation Guide. John Wiley & Sons, 2017. Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice. Nally, Joseph D. Good Manufacturing Practices for Pharmaceuticals, 6th ed. 2007. Annex 3, Good Manufacturing Practices: Guidelines on Validation. Documentation and Records: Harmonized GMP Requirements, K.T. Patel and N.P. Chotai.
| content serial | Description |
|---|---|
| 1 | GMP, drug regulation organizations and product recall theory. (Lecture) |
| 2 | Departments of pharmaceutical industry. (Lecture) |
| 3 | Facilities of pharmaceutical plant (Definition, types & importance). (Lecture) |
| 4 | Validation and cleaning validation. (Lecture) |
| 5 | Documentation and records. (Lecture) |
| 6 | Personnel qualifications, training and hygiene. (Lecture) |
| 7 | Design of pharmaceutical industry and Clean Room Concept. (Lecture) |
| 8 | Equipment cleaning and maintenance. (Lecture) |
| 9 | Risk management. (Lecture) |
| 10 | Audit. (Lecture) |
| 11 | Quality Management. (Lecture) |
| 12 | Overview of statistical process control, Process Capability Analysis. (Lecture) |
| 13 | Measurement System Analysis (MSA).(Lecture) |
| 14 | Control Charts. (Lecture) |
| 15 | Case studies. (Lecture) |
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