Batch Record Review as GMP Deviation cited in FDA Warning Letters

As indicated by ECA's Warning Letter Report (see our GMP News from 2. February 2011), Production Record Review deviations are (again) the most frequent GMP observations made by the FDA. In the previous periods, observations regarding this subject were always No.1 or No.2 in the ranking of cited GMP deficiencies. 

After a closer look at these citations, it becomes obvious that most observations are caused by failures in deviation management and CAPA. However the FDA has also made observations regarding the review of production records. And those are not always listed under 21 CFR 211.192, Subpart J - Records and Reports, Production Record Review .

Examples are:

  • "Your firm's QCU did not review or approve batch production record" (cited as 211.192 'Production Record Review' observation)
  • "You have not established a Quality Control Unit (QCU) that reviews batch records for accuracy. The responsible official only reviews batch records when personnel note a problem with the finished product" (cited as 211.22 'Responsibilities of quality control unit' observation)
  • "Your QCU failed to adequately review production and control records to ensure no errors occurred" (cited as 211.22 'Responsibilities of quality control unit' observation)
  • "You did not review the executed batch records to identify discrepancies, deviations, or interventions that may have occurred during the manufacture" (cited as 211.42 'Design and construction features' observation)

Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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