On the 11th of May, the FDA announced the release of the final guidance for industry entitled: “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.”
This was prepared under the support of the International Council for Harmonisation (ICH). ICH Q12, which was originally adopted as an ICH Guideline in November of 2019, establishes which elements are necessary to assure product quality. Additionally, it provides a framework to facilitate the management of post approval chemistry, manufacturing, and controls (CMC) changes for any new and marketed pharmaceutical drug substances and drug products. This includes chemical and biotechnical/biological products.
The document (linked above) also includes internationally harmonized tools and enablers that should enhance the industry’s ability to manage many CMC changes effectively under a company’s Pharmaceutical Quality System (PQS). ICH Q12 finalizes the FDA draft guidance of the same title issued May 31, 2018. This guidance is also intended to complement the existing ICH Q8 to Q11 guidances.
To read the full announcement, please visit the FDA’s website.
If you have any additional questions regarding this update or need any assistance regarding FDA compliance and regulation, please email mdi Consultants at email@example.com RE: IHCQ12.