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FDA expects internal Quality Control Units to detect problems and help ensure compliance

  • FDA is taking a more systemic and risk-based approach to GMP compliance and is paying close attention to the activities of the Quality Control Unit

  • The following statements from recent Warning Letters illustrate FDA’s concern:

  • “[The observed GMP deficiencies are] indicative of your quality control unit not fulfilling its responsibility to assure the identity, strength, quality, and purity of your manufactured product.”

  • “Please explain why your firm’s Quality Control Unit (QCU) did not detect and document these deficiencies during their batch production and control and what actions will be taken to assure these deficiencies do not extend to other batches of the same or other drug product.”

  • “Failure to conduct investigations in a timely manner and to extend the investigations to other drug products that may have been impacted … demonstrate the failure of your QCU to provide adequate oversight and ensure procedures are followed.”

  • These passages underscore the critical role that Quality Control Units

play and how carefully FDA evaluates their performance

© 2009 Hogan & Hartson LLP. All rights reserved.

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