Module 3 Presentations

07/05/2024

Lecture 6: Developing Specifications for the Active Ingredient

Christian Maasch, adopted from K.Foster (P&G) Head of Quality Regulatory Compliance, Change Control Mgmt & Deputy Quality Systems

Takeda GmbH, Oranienburg, Germany May 16 th ,2024

Disclaimer: Confidential. For internal use only. The opinions expressed in this presentation and on the following slides are solely those of the presenter and not necessarily those of Takeda. Takeda does not guarantee the accuracy or reliability of the information provided herein.”

The Organisation for Professionals in Regulatory Affairs

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Learning Outcomes

1. Dossier requirements and specification definitions (ICH Q6A) 2. Adjusting Specifications during development (QRM/Stage Risk Approach) 3. Justification of Specifications (How do we do this?) 4. Short Excurse of Elemental impurities and Nitrosamine Testing 5. How does Real Time Release affect the control strategy 6. Comparison of RTRt with Traditional Specification / Control Strategy -> bridging ICH Q8,Q9,Q10,Q11

Developing Specifications for the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

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