New in the ECA Members Area: "QA Responsibilities" in the Mirror of Warning Letters

The way the quality assurance unit in a pharmaceutical company carries out its responsibilities is always the focus of an FDA inspection. The inspectors can very quickly get an idea of the basic GMP understanding of a production site if they look at the competence and authority with which the quality assurance staff carry out their tasks, enforce them in the company and to what extent they are supported in this by the management.
The responsibilities of the Quality Unit are clearly described in the Code of Federal Regulations, 21 CFR 211.22. Although the very first sentence of this regulation begins with the words, "There shall be a quality control unit...", it is not uncommon for FDA inspectors to encounter establishments where there is no quality control unit as defined by 21 CFR 211.22.

The systematic analyses of the Warning Letters, which are regularly carried out by CONCEPT HEIDELBERG on behalf of the ECA, show interesting details here. A special presentation of the "Failures" described in the Warning Letters of the past fiscal year (FY 2022) shows an extract of the GMP violations in quality assurance (each in the original wording), structured as follows:

  • Description of GMP Failure 
  • Feedback from the company 
  • Feedback from the FDA 
  • Request for documents/evidence from the FDA

This focussed presentation allows a detailed view of the topic "QA responsibilities", quasi through the eyes of the FDA inspectors, and offers a compilation of the documents that the inspected company has to provide - in order to avoid a threatening suspension of deliveries - under the heading "Subsequent requirements" ("What the company should provide").

When preparing for an FDA inspection, it can be useful to have a look at such a topic-centred compilation of the "failures".

In the members' area of the ECA website, the topic-focused presentation on the "QA responsibilities" can be found as an extract from the Warning Letters. Further such presentations on important cGMP topics from current Warning Letters are in progress and will be available shortly.

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