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US FDA Trains Reviewers For Consistency On Post-Q12 Manufacturing Changes

 
• By Joanne S. Eglovitch

Anticipating the eventual adoption of ICH Q12, the US FDA is training staff on some of its key principles. An agency official says ICH Q12 necessitates a new way of thinking about and reviewing regulatory submissions for post-approval changes and such training is necessary to ensure review consistency.

Business Team Training Listening Meeting Concept - Image
The FDA trains staff on ich q12 as guidance nears final approval • Source: Shutterstock

The US Food and Drug Administration has launched a training program for agency reviewers on some of the core concepts in the International Council for Harmonization’s draft Q12 guideline on pharmaceutical product lifecycle management. The draft guideline has prompted a new way of thinking about manufacturing changes, and the agency wants to ensure that reviewers are on the same page ahead of its eventual adoption, expected in November.

Kavita Vyas, a reviewer in the FDA’s Center for Drug Evaluation and Research, described the elements of the training at the CASSS CMC Strategy Forum on 16 June in Gaithersburg,...

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