SUPAC-like container closure guidance for post-approval changes suggested by PhRMA.
This article was originally published in The Tan Sheet
Executive Summary
SUPAC-LIKE GUIDANCE FOR CONTAINER CLOSURE POST-APPROVAL CHANGES should be considered, the Pharmaceutical Research & Manufacturers Association says in Nov. 14 comments on FDA's draft guidance on "Submission of Documentation in Drug Applications for Container Closure Systems Used for the Packaging of Human Drugs and Biologics." Consideration should be given to "developing a separate guidance for post-approval packaging changes," PhRMA suggests. The guidance "should follow the paradigm established" in recently issued Scale-Up and Post-Approval Changes guidances, PhRMA adds, to "provide more flexibility for manufacturers without compromising quality."
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