New FDA Draft Guidance Lessens Reporting Requirements for Postapproval Manufacturing Changes

Jul 02, 2010

The US Food and Drug Administration has issued a new draft guidance regarding the types of manufacturing changes that can be reported in annual reports.

The guidance lists 44 postapproval manufacturing changes that may now be reported in annual reports instead of supplements, because the changes are considered to be of low risk to product quality. Examples of these changes include: the elimination or reduction of an overage from the drug product manufacturing batch formula, changes to filtration process parameters, changes in the approved analytical procedure if the revisions do not change the acceptance criteria, and replacement of nonspecific identity tests with discriminating identity tests. The entire list can be found on the FDAs web site.

The draft guidance seeks to reduce the number of CMC manufacturing supplements for NDAs and ANDAs, which have been steadily increasing over the last several years.

This draft guidance also reflects an ongoing shift at the agency toward implementing risk-based approaches to manufacturing quality.

This approach was first outlined in 2002 in the FDA's cGMPs for the 21st Century Initiative, now referred to as the Pharmaceutical Product Quality Initiative, in which the FDA stated that CMC product review should be based on an understanding of product risk and how best to manage that risk with limited agency resources.

Comments on the draft guidance should be submitted by September 23, 2010.

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