Under the cGMPs the role/responsibilities of the quality unit are described in Subpart B Organization and Personnel, specifically 21 CFR 211.22.

However, these roles/responsibilities are not always implemented or effective by pharmaceutical manufacturers.  As described in a recently posted FDA Warning Letter, the FDA cited a manufacturer of OTC products with significant failures of the Quality Unit.  In summary these were:

  1. Lack of quality control over batch release – The Quality unit allowed the release of multiple lots of alcohol-free hand sanitizer that failed its finished project specifications for aerobic microbial count for bacteria and yeast/molds.  Additionally the firm’s laboratory testing identified Burkholderia Cepacia in three lots that were subsequently released.
  2. Lack of Procedures and Responsibility for Finished Product Specifications and the Stability Program – API specifications were changed numerous times for the finished product assay as the firm was in the process of “optimizing” and performing a justification for the specification.  Establish a stability program.

The end result is that this firm ceased production and distribution of drug products from the site as of June 30, 2021.

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