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FDA Draft Guidance on Quality Agreements for Drug Contract Manufacturing Nears Release

Mar 25th, 2013

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An FDA cross-center working group has developed a draft guidance on quality agreements for drug contract manufacturing that is undergoing the final stages of FDA internal review and is expected to be released for public comment this summer.

The work group includes representatives from the centers for drugs, biologics and veterinary medicines as well as the field organization.  Work began on the draft in the summer of 2011.

Highlighting the upcoming release of the draft guidance at a supply chain conference cosponsored by Xavier University and FDA in Cincinnati, Ohio in mid-March, Cincinnati District Field Investigator and Drug Preapproval Manager Kathleen Culver, who participated on the working group, commented that “it was a very good experience to hear the viewpoints of the Center people.  And I think it was a very good experience for them to hear some of our ORA war stories.”

Although Culver could not comment on the specifics of the guidance since it is still under internal review, she did discuss some of the fundamental principles reflected in it.

She pointed to the 1978 preamble to the GMPs as providing an important foundation and remarked on its prescience.

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