Module 3 Presentations

07/05/2024

Good Manufacturing Practice – Clinical Supply

Fiona Routley, Qualified Person Director, Clinical Supply Quality, AstraZeneca April 2024

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals in Regulatory Affairs

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Learning Outcomes

• Key Clinical Trials Legislation • Understanding of Good Manufacturing Practices (GMPs) for Investigational Medicinal Products (IMPs)

• GMP Challenges for Clinical Trials Manufacturing • Role of the QP and batch certification of IMPs • Impact of Brexit for the QP • What’s New / Regulatory Impact

The Organisation for Professionals in Regulatory Affairs

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