(FDA)announces the availability of a final guidance for industry entitled “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.” ICH Q12, which was prepared under the support of the International Council for Harmonisation (ICH), provides a framework to facilitate the management of postapproval chemistry, manufacturing, and controls (CMC) changes for new and marketed pharmaceutical drug substances and drug products, including chemical and biotechnological/biological products.
ICH Q12, which was adopted as an ICH Guideline in November 2019, establishes which elements in an application are considered necessary to assure product quality and therefore would require a regulatory submission if changed postapproval. The guidance includes internationally harmonized regulatory tools and enablers which, when utilized in combination with increased product and process knowledge, should enhance industry’s ability to manage many CMC changes effectively under a company’s Pharmaceutical Quality System (PQS) with less need for extensive regulatory oversight prior to implementation. ICH Q12 finalizes the FDA draft guidance of the same title issued on May 31, 2018. ICH Q12 promotes innovation and continual improvement in the pharmaceutical sector and will strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments. The Q12 guidance is intended to complement the existing ICH Q8 to Q11 guidances....[FDA]