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QCU Issues: Top Reason for FDA-483 Citations Among Drug Companies

FDA CDER Official Talks About Common Quality Control Issues that Cause FDA-483 Citations

If you're looking to improve a single area in your FDA compliance initiatives, look no further than your quality control unit (QCU). A report by an official of the Center for Drug Evaluation and Research (CDER) shows that QCU-related issues comprise the Number One reason why pharmaceutical companies receive FDA-483 citations.

The report, prepared by Kristen Evans, senior regulatory operations officer for CDER's Office of Compliance (Division of Manufacturing and Product Quality), showed FDA inspection trends involving pharmaceutical companies that received FDA citations in 2005.

21 CFR Part 211.22(d) - the regulation pertaining to QCU - provides: "The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed."

Evans, a veteran FDA investigator, said this problem has been historically Number Two, but it became Number One recently. ?And it might be because we're putting more emphasis on this regulation ? the need for firms to adopt modern quality system concepts,? he said.

Asked which top three areas are most likely to be scrutinized during an FDA inspection, Evans identified the following: manufacturing processes and whether they are validated, how a company resolves deviations, and how a company handles out-of-specification laboratory results.

In an interview with MasterControl Inc., Evans talked about a wide range of topics related to FDA inspections, including the most common reasons why pharmaceutical companies receive FDA-483 citations, what they should do when they receive an FDA citation, how to prepare for an FDA inspection, and what FDA investigators look for in terms of training control and CAPA.

Read the interview in its entirety:

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FDA Links

  • Final Guidance – Quality Systems Approach to Pharmaceutical CGMPs
    Link


  • Compliance Program Guidance Manual for FDA Staff – Drug Manufacturing Inspections
    Link

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