Regulatory Compliance and Quality Control in Pharmaceutical Manufacturing

Module Objectives

To provide a comprehensive understanding of the regulatory affairs associated with pharmaceutical manufacturing and quality control processes, with a focus on professionalism, ethical considerations, and problem-solving strategies. This module explores the legal, ethical, and professional responsibilities associated with drug production. It also dives into specific routines and tools used in quality control and assurance and provides an overview of risk and personnel management in the context of pharmaceutical manufacturing.

Intended Module Learning Outcomes

After successfully completing this module, students should be able to …

Evaluate the role and responsibilities of personnel involved in the production and release of finished drug products.

Apply knowledge of regulatory frameworks and professional codes of conduct to hypothetical pharmaceutical manufacturing scenarios.

Demonstrate problem-solving skills in response to critical batch release situations.

Assess risk management techniques and their application in the pharmaceutical manufacturing industry.