CRED Getting the CMC Dossier Right 2024

28/08/2024

DS Lifecycle Management: ICH Q12 [2]

ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

PQS: All information related to manufacturing and testing of a product; includes facility, environmental controls, etc. Control Strategy: reported in Module 3. Contains binding information on control strategy elements of product, process controls, etc. as well as supportive information. Established Conditions: Legally binding information considered necessary to assure product quality. The Product Lifecycle Management Document (PLCM) serves as a central repository to provide transparency and facilitate strategic approaches to lifecycle management including regulatory assessment and inspection.

However ICH Q12 not (yet) globally implemented

The Organisation for Professionals in Regulatory Affairs

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Summary

• Early regulatory involvement in process development teams is essential • Process knowledge and understanding should increase as the development progresses • Expectations evolve with the product development (e.g. Process, analytical, stability and GMP) • Expect the unexpected • Once you have registered it, you must comply with your commitments!

The Organisation for Professionals in Regulatory Affairs

28