GMP for clinical trials manufacture and supply

As much as GMP is important for drugs that are approved to market by the FDA/EMA, it is equally pivotal for investigational medicinal products that are still undergoing clinical trials. Understanding and applying current GMP requirements to practice while manufacturing clinical trial material ensures that the investigational drugs and medicinal products are consistently produced under stringent quality control activities.

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum:

Introduction

Lesson 1: Quality Management of IMPs

Lesson 2: Quality Risk Management

• Control, Communication, and Review of Quality Risks

Lesson 3: Personnel Management

Lesson 4: Documentation of IMPs

• Manufacturing Formulae & Packaging Instructions
• Labeling Instructions
• Batch Manufacturing Records
• Coding Systems

Lesson 6: Production for Clinical Trials Manufacture

• Manufacturing operations
• Packaging and Labeling
• Blinding

Lesson 7: Qualification and validation

Lesson 8: Recalls and market returns

Lesson 8: Shipping

Lesson 9: Destruction

Glossary

Conclusion

Evaluation