Warning Letter Report - Data Base Publication

GMP News No. 251

GMP News
29 October 2002
 

Warning Letter Report - Data Base Publication

 
Every now and then, we receive inquiries concerning details of our analysis of the FDA Warning Letters (see GMP News of 18 June 2002 on Warning Letter Report).
Up to now we have not published such details. However, now we intend to publish detailed data regarding specific complaints in the ECA Members Area time after time. This compilation will render it unnecessary to search all Warning Letters for specific deficiencies (e.g. OOS). We have sorted out the relevant text passages for you. In the months to come, the following evaluations will be published (each time 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 release for distribution)
  • 21 CFR 211.166 (Stability testing)
  • 21 CFR 211.188 (Batch production and control records)
  • 21 CFR 211.192 (Production record review)
  • 21 CFR 211.22 (Responsibilities of quality control unit)
  • 21 CFR 211.25 (Personnel qualifications)
  • 21 CFR 211.67 (Equipment cleaning and maintenance)
  • 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures)

The following freely-available example concerning complaints/complaint handling demonstrates how the system works. Here you can see the evaluation results for 21 CFR 211.198 (Complaint Handling).

Writer:
Oliver Schmidt
CONCEPT HEIDELBERG
  

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