Description

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.

Program

PharmD

Objectives

• Domain (1): Fundamental knowledge By the end of the course the student should be able to: Recognize the golden rules of Good Manufacturing Practice. Describe the importance of quality management, validation, documentation, facilities, equipment maintenance & environmental monitoring in maintaining GMP compliance. Identify the role of GMP in the lifecycle of pharmaceutical products, from development to distribution Domain (2): Professional and Ethical Practice At the end of the course the student should be able to: 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 to the organization guidelines. 2.3 Comply with procedures to manage risk and improve safety in the manufacturing processes Domain (3): Pharmaceutical Care At the end of the course the student should be able to: Domain (4): Personal Practice At the end of the course the student should be able to: 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.