Spring Intro 2023

28/03/2023

3.2.S.2.6. Manufacturing process Development

● Follow ICH Q11 principles: i.e.

Define an appropriate manufacturing process addressing CQAs

Define a control strategy to ensure process performance and DS quality

Identify potential CQAs of the Drug substance

3.2.S.2.6 has become a very large section of the dossier now, even for post-approval changes (~1,000 pages for one variation)

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Telling a consistent story…

Identified critical process parameters to deliver quality attributes

Manufacturing Process Development

Confirmed that CPPs and CQAs were consistently achieved by the process

Manufacturing Process Validation

Defines how the future commercial process will be controlled to deliver consistent DS

Manufacturing Process Description

The Organisation for Professionals in Regulatory Affairs

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