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FDA Lays Out Which Postapproval Manufacturing Changes for Biologics Are ‘Minimal’

05:11 EDT 11 Aug 2017 | Genetic Engineering News

Which manufacturing changes have the least potential to adversely affect product quality? That’s the question the FDA has attempted to answer in a new draft guidance released this week. FDA released the draft guidance in response to an increase in the number of postapproval manufacturing supplements it has received in recent years. Specifically, industry has sought FDA recommendations on the types of changes that can be documented in an annual report, rather than in a supplement. The changes FDA is recommending be included in such an annual report are focused on five areas: Components and composition; manufacturing sites; manufacturing process, batch size and equipment; specifications and container closure systems. Many of the changes included in the appendix and to be documented in an annual report are either slight modifications or those that would have no impact on the current risks of the manufacturing. For instance, ...

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