Warning Letter Report - Data Base Publication

GMP News No. 251

GMP News
29 October 2002

WarningLetter Report - Data Base Publication

Every now and then, we receive inquiries concerning details of our analysis ofthe FDA Warning Letters (see GMPNews of 18 June 2002 on Warning Letter Report).
Up to now we have not published suchdetails. However, now we intend to publish detailed data regardingspecific complaints in the ECA Members Area time after time. Thiscompilation will render it unnecessary to search all WarningLetters for specific deficiencies (e.g. OOS). We have sorted out the relevanttext passages for you. In the months to come, the following evaluations will be published (eachtime after prior announcement) for ECA members only:

  • 21 CFR 211.100 (Written procedures;deviations)
  • 21 CFR 211.160 (Laboratory controls,general requirements)
  • 21 CFR 211.165 (Testing and releasefor distribution)
  • 21 CFR 211.166 (Stability testing)
  • 21 CFR 211.188 (Batch production andcontrol records)
  • 21 CFR 211.192 (Production recordreview)
  • 21 CFR 211.22 (Responsibilities of qualitycontrol unit)
  • 21 CFR 211.25 (Personnelqualifications)
  • 21 CFR 211.67 (Equipment cleaning andmaintenance)
  • 21 CFR 211.84 (Testing and approval orrejection of components, drug product containers, and closures)


Oliver Schmidt


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