CMC Regulatory Updates In Brief: CSL's Haegarda Specs; CMC Data Elements; ICH Q3C Maintenance
US FDA explains why it requested CSL Behring to reinstate non-critical manufacturing process controls and tighten container specs in line with process capability. FDA also proposes CMC data elements and posts ICH Q3C updates.
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FDA announces the rollout of a pilot program with industry to exchange data on quality specifications for the Common Technical Document’s Module 3. The agency plans to exchange data on other portions of the CTD’s quality section later this year. The data exchange would largely replace the “hunting and pecking” for information in PDFs that reviewers have to do to locate quality information in NDAs and ANDAs.
FDA wants feedback on a proposal to standardize the data elements of the quality and chemistry, manufacturing and controls portions of applications. The agency says such a plan will enable consistency in the content and format of CMC data submitted, thus providing a consistent look and feel for every application.
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