Harmonized Lifecycle Management Policy Aims to Drive Drug Quality and Innovation
FDA recently published a final guidance for making post-approval manufacturing changes to drugs and biologics, the culmination of a long-running effort to facilitate improvements in medical product quality through the product life cycle.
FDA recently published a final guidance for making post-approval manufacturing changes to drugs and biologics, the culmination of a long-running effort to facilitate improvements in medical product quality through the product life cycle. The Q12 standard crafted by members of the International Council for Harmonisation (ICH) aims to help manufacturers manage changes in chemistry, manufacturing, and controls (CMC) of marketed drugs and biologics, including generics and biosimilars and certain combination products, to encourage continual improvement in biopharmaceutical production.
The main premise of the Q12 standard is that increased product and process knowledge can enhance understanding of which postapproval changes have potential to affect product quality and carry risks for patients. Such changes would require regulatory approval prior to implementation. But manufacturers can reduce such oversight by managing CMC changes through a Pharmaceutical Quality System (PQS) that can identify and manage those Established Conditions (ECs) of a product that are essential to assuring quality and safe use.
Through such efforts, FDA officials and other regulatory authorities hope to provide “a more predictable and efficient approach to management of postapproval changes,”
This international effort to gain agreement on policies for overseeing postapproval manufacturing changes builds on a long series of ICH quality manufacturing standards. Ashley Boam, director of CDER’s Office of Policy for Pharmaceutical Quality,
The
Manufacturers may be able to shift more changes to the notification category by devising a control strategy upfront for accomplishing later innovations. Q12 discusses the value of preparing post-approval change management protocols (PACMPs) and a product lifecycle management document early on to facilitate future improvements.
To further assist manufacturers in utilizing and benefiting from the Q12 process, FDA issued a
Global implementation key
The value and impact of ICH Q12 will depend on its adoption and use by regulatory authorities around the world. Wide acceptance of a modernized change management process is key for manufacturers to be able to implement improvements to authorized products more quickly and efficiently, in order to encourage investment in modern manufacturing systems in multiple markets.
To this end, FDA and other regulatory authorities are devising and offering training for pharmaceutical reviewers and inspectors that helps them understand and utilize the Q12 process. An ICH Implementation Working Group is developing global training materials for regulatory authorities and working with PIC/S on training for inspectorates, Boam noted. Topics of the training modules include established conditions for various products, drug-device combination products, and change management protocols.
And manufacturers have gained additional advice on utilizing Q12 through another FDA guidance that maps out the new process. The
The larger goal of this harmonized postapproval changes policy is to encourage manufacturers to adopt innovations in product quality and production. More effective management of changes ideally will help avoid supply disruptions and shortages arising from drug quality issues, increase efficient use of resources, and facilitate innovation in pharmaceutical manufacturing.
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