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CDER Will Focus on Part 11 Compliance in Upcoming Inspections

Aug 7th, 2010

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FDA’s Center for Drug Evaluation and Research (CDER) will be conducting a series of inspections of drug manufacturers that will evaluate the industry’s understanding of and compliance with the Part 11 regulations.  The inspection findings will be used to assess whether or not the agency’s related regulations and guidance need to be adjusted.

CDER announced that it will begin the inspections at manufacturing and clinical investigation sites both in the US and abroad in the near future.  The agency will not disclose how the sites will be selected for inspection nor provide advance notifications of inspection to those sites.

In a mid-July press release, CDER pointed out that concerns with the 1997 regulation were addressed in its August 2003 “Scope and Application” guidance, which limited the way Part 11 would be enforced during inspections and provided discretion in interpreting compliance.  The press release explains that CDER “intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections that do not fall under the enforcement discretion discussed in the guidance.”

In the wake of this announcement, ISPE held a webinar on the new inspection initiative.  Conformity Director Sion Wyn and CDER Office of Compliance (OC) Project Management Officer George Smith provided background and details on the upcoming effort.  Wyn is an advisor to FDA on Part 11; Smith is co-chair of the FDA Part 11 working group.

[Wyn’s and Smith’s perspectives on CDER’s Part 11 inspection initiative are provided for subscribers on page 2.]

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