CMC Regulatory Science Forum

Programme overview



The  Q12 guideline Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, and associated Annex, were released  for public consultation at Step 2 in December 2017.  In Europe the deadline for comments on the draft document  was 18 December 2018.

From March  until June 2019, the  Q12 EWG have scheduled  meetings to discuss the comments  received, resolve issues and and progress the guideline.  The current Q12 workplan indicates that the guideline is expected to be signed off at Step 3 by the technical experts in June 2019, and adoption at Step 4 is expected in the second half of 2019.

This guideline provides a framework to facilitate the management of post-approval CMC changes in a more predictable and efficient manner across the product lifecycle, and augments the existing quality guidelines ICH Q8, Q9, Q10 and Q11.

It describes a number of important principles, regulatory tools and enablers which will facilitate life-cycle management; these include categorisation of Post-Approval CMC Changes, Established Conditions, Post-Approval Change Management Protocol (PACMP), Product Lifecycle Management (PLCM), use of the Pharmaceutical Quality System (PQS) and Change Management.

Effective implementation  of the these tools and enablers should enhance industry’s ability to manage  CMC changes effectively under a company’s PQS with less need for extensive operational oversight prior to implementation.

The extent of operational and regulatory flexibility will depend on the extent of product and process understanding (ICH Q8 and Q9), application of risk management principles (ICH Q9) and use of an effective PQS  (ICH Q10).