Spring Intro 2023

28/03/2023

3.2.P.3.3 Manufacturing Process Description Deep dive

Step by step description of the manufacturing process, sufficient to give the reviewer / assessor an understanding of how the unit processes are run and controlled Avoid exhaustive detail – do not file batch record level of detail! Critical Quality Attributes clearly called identified and control strategies called out. CQAs are identified by process risk assessment, should be reasonable in number Specific product types require particular information in detail, e.g. - Aseptically produced products: location of sterile filters, bioburden sampling points and limits, hold times. All need to be defined.

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3.2.P.3.5. Process Validation Deep Dive

Typically 3 batches (of DP), using more than one DS lot, but matrix approaches can be used, e.g. where there multiple strengths. This should be justified Other approaches (e.g. continuous process verification) are encouraged, but not widely adopted yet (FDA Guidance 2011, EU Guidance 2014) Process Validation should be consistent with rest of dossier – e.g. critical quality attributes and critical process parameters should be addressed by validation Aseptic products – essentially 2 elements to process validation. Validation of the process itself (formulation, fill, lyophilisation), Validation of the sterility assurance of the process and facility (typically by media simulation) Key point – based on your data / reports, can you conclude that you have a validated process?

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