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21 Feb 2024

Case analysis: 483 observations – Data Integrity issues in a pharmaceutical finished dosage formulation plant

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The US Food and Drug Administration has pointed out data integrity lapses at XYZ Pharma’s finished dosages plant at <Location>.

The FDA issued Form 483 with 7 key observations to XYZ Pharma on the plant which was audited by the US drug regulator between May 13 and May 24, XXXX.

Summary of Points raised by USFDA:

  1. Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
  2. Specifically, there is no adequate data integrity program in place to include an adequate review of all electronic raw data by the quality unit to ensure completeness, consistency, and accuracy of all chromatographic raw data generated by the quality control (QC)laboratory.
  3. None of the observations are repetitive and are more procedural in nature.
  4. USFDA observation noted – “Further, during the inspection your firm performed an assessment of all your electronic data generated from January 2018 to April 2019. Out of 112 projects, 39 projects were identified to have integrity failures (data missing/incomplete data),from which 123 channels for chromatograms is showed incomplete data.”
  5. The audit report also said written procedures at the facility are not followed for the cleaning and maintenance of equipment including utensils used in the manufacture, processing, packaging are holding of a drug product.
  6. The FDA inspectors also found a PVC pipe connected to an air- conditioner unit on one end and the other end in a plastic bucket which was filled with 50 per cent of ‘condensate water.’
  7. The report pointed out that there is no documentation of these activities and the similar set-up was found in four other places.

 

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