Deviations Regarding Documentation in FDA Warning Letters

GMP News No. 403

GMP News
6 April 2004
 

Deviations Regarding Documentation
in FDA Warning Letters


Although during the past years almost all pharmaceutical companies have thought a lot about the topic of "GMP/FDA-compliant documentation in the laboratory," the complaints about laboratory records (21 CFR 211.194) were again among the top ten of FDA Warning Letters in the Fiscal Year 2003.

Some of them referred to the following points:

  • The records did not contain the complete raw data for all the laboratory testing performed.
  • The periodic calibration of the laboratory instruments was not documented completely in the laboratory records.
  • The records did not include the reason for the modification of a test method.
  • The laboratory records did not include a statement on the identity of the reference standards used and on the method with which these were produced.
  • The laboratory records did not include the initials or signature of a second person showing that the original records had been reviewed for accuracy, completeness, and compliance with established methods.
  • The records that were meant to document compliance with established methods were incomplete.

This small selection proves that the topic of "GMP/FDA-compliant documentation in the laboratory" cannot be considered closed. If you are interested in viewing the complete list of deviations from our data pool for the FDA Warning Letters Report, just click here.
   

Good Documentation Practice is one of the subjects discussed at our 3-day intensive seminar  FDA and GMP Compliance in Quality Assurance Units  in Vienna, Austria, from 21-23 April 2004.

Especially on the topic of documentation and the handling of out-of-specification results, we are organising our  Education Course Out-of-Specification Results with a Post-course Workshop Failure Investigation   in Berlin, Germany, from 16-18 June 2004.

Practical people with experience will inform you about current requirements and their clever implementation.

 
Author:
Dr Ulrich Herber
CONCEPT HEIDELBERG

 

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