CRED Getting the CMC Dossier Right 2024

28/08/2024

3.2.P.3 Manufacture [2]

Description of Manufacturing Process

Flow diagram and narrative description of operations (& scale) with in-process controls

➢ Pure GMP aspects not needed in the dossier ➢ Level of detail depending on criticality of process steps; align with 3.2.P.2 ➢ Several (slightly) different processes are possible, e.g. due to other equipment/ alternative production sites

Guidance: EMA guideline „Manufacture of finished Dosage Form“, ICH Q12

The Organisation for Professionals in Regulatory Affairs

Getting the CMC dossier right – module 3.2.P

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3.2.P.3 Manufacture [4]

Critical Steps and Intermediates ➢ List of in-process controls

➢ Distinct intermediates of the process with specifications – align with 3.2.P.2 ➢ If applicable: holding time stability (be aware of start of shelf-life rules!)

Process Validation(s)

Demonstration that the process(es) reliably generate the intended product

➢ 3 full scale batches - in EU, pilot-scale batches or bracketing possible, e.g. for different batch sizes/ strengths (full scale validation plan may be shown in 3.2.R) ➢ More stringent requirements may apply for non-standard formulations, e.g. aseptic, low-content or modified release.

Guidance: EMA guideline „Manufacture of finished Dosage Form“, ICH Q12

The Organisation for Professionals in Regulatory Affairs

Getting the CMC dossier right – module 3.2.P

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