This module aims to equip the learners with the fundamental theoretical and practical skills that are required to work in a GMP-compliant manufacturing environment.

This blended course of 4days (including 2 days NIBRT onsite and 2 days online) includes interactive theory and practical hands-on training to equip participants with the essential knowledge and skills needed to operate in a GMP-compliant manufacturing environment. Students will develop an understanding of GMP principles, industry best practices, and regulatory expectations, enabling them to support consistent, high-quality production outcomes.

1. Demonstrate solid foundational understanding in Good Manufacturing Practice (GMP), its regulatory basis, and its essential role in ensuring that biopharmaceutical products are consistently produced to high-quality, safety, and efficacy.
2. Describe the role of global regulatory agencies, their impact on biopharmaceutical production and GMP, and the importance of quality systems within manufacturing facilities.
3. Describe effective contamination control strategies in a GMP environment, including proper gowning procedures, aseptic technique, equipment sanitisation, and environmental monitoring.
4. Participate in workshops to understand how to capture and analyse data from manufacturing processes, investigate and manage deviations, and implement corrective and preventative actions to ensure process adherence and continuous improvement.
5. Undergo a mock inspection process to understand the regulatory inspection process and gain skills for ensuring successful completion of such inspections as a manufacturing operator.