FDA And Industry Officials Tout Benefits Of Performance-Based Established Conditions In ICH Q12
ICH given “two thumbs up" for performance-based established conditions concept in draft Q12 guideline. This approach gives industry much needed flexibility in managing post-approval changes as well as requesting fewer changes from regulators.ICH plans to adopt the guideline as a Step 4 document in 2019.
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Performance-Based Conditions Could Ease Post-Approval Changes For Process Analytical Technologies, Experts Say
Pharmaceutical industry officials are promoting the idea of “marrying” the concepts of performance-based approaches and process analytical technology in the draft ICH Q12 guideline. Embedding this idea in ICH Q12 would give industry more flexibility in managing post-approval changes and aligns with the guideline’s concept of lifecycle improvement.
ICH finally proposes a way to resolve the regulatory complexity that has prevented drug makers from establishing and perfecting global approaches to manufacturing their drug products. But with legal concerns persisting in Europe and possibly lurking elsewhere, approval of ICH's draft Q12 guideline could be difficult.
2020 is when supply chain partners must agree on a vision for the track-and-trace anticounterfeiting system due in November 2023, experts tell the Pink Sheet.