ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management

New guidance from the EMA has been published in March 2020. This guideline provides a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner.  A harmonised approach regarding technical and regulatory considerations for lifecycle management will benefit patients, industry, and regulatory authorities by promoting innovation and continual improvement in the pharmaceutical sector, strengthening quality assurance and improving supply of medicinal products.

The focus is with pharmaceutical drug substances (APIs) and products (both chemical and biological) that require a marketing authorization; drug-device combination products; and with analytical methods.

To access, see: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q12-technical-regulatory-considerations-pharmaceutical-product-lifecycle-management_en.pdf

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)