ICH Q12 revision process

The EMA has published industry comments gathered during its public consultation for the ICH draft guideline on pharmaceutical product lifecycle management (ICH Q12).

This new guideline is proposed to provide guidance on a framework to facilitate the management of post-approval chemistry, manufacturing and controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. This guideline aims to promote innovation and continual improvement, and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments. The guideline strives to promote, for regulators (assessors and inspectors), an improved understanding of the Applicants' pharmaceutical quality systems (PQSs) for management of post-approval CMC changes. This new guideline is intended to complement the existing ICH Q8 to Q11 guidelines.

For details, see: https://www.ema.europa.eu/en/ich-q12-technical-regulatory-considerations-pharmaceutical-product-lifecycle-management

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology