FDA Issues Draft ICH Guidance on Pharmaceutical Product Lifecycle Management

The FDA released the ICH’s Q12 draft guidance on pharmaceutical product lifecycle management (PLCM) for post-approval changes in chemistry, manufacturing and controls.

All PLCM documents, the guidance states, should contain a high-level summary of the product control strategy that clarifies and highlights which aspects of the control strategy should be considered established conditions (ECs).

Post-approval change management protocols (PACMPs) submitted by sponsors to implement one or more post-approval changes should also be listed with the corresponding ECs to be changed, according to the guidance. Any PACMPs submitted and approved after approval of the original application should be accompanied by an updated PLCM document.