Deviations Regarding Documentation in FDA Warning Letters

GMP News No. 403

6 April 2004

in FDA Warning Letters

Although during the past years almost all pharmaceutical companies havethought a lot about the topic of "GMP/FDA-compliant documentation inthe laboratory," the complaints about laboratory records (21 CFR211.194) were again among the top ten of FDA Warning Letters in the FiscalYear 2003.

Some of them referred to the following points:

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

This small selection proves that the topic of "GMP/FDA-compliantdocumentation in the laboratory" cannot be considered closed.

Dr Ulrich Herber


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