FDA Warning Letter Due to Lack of Stability Data and Specifications for APIs

A recent Warning Letter describes fundamental GMP deficiencies in the quality control area at the manufacturing facility of topical analgesics' manufacturer.

Lack of specifications for testing APIs

The documentation requested by the FDA from the manufacturer lacked both specifications for the APIs used and evidence that incoming testing of these APIs had taken place. The documentation only contained records of the final product testing. The FDA concluded that the manufacturer routinely used non-tested APIs in the manufacture of the analgesic.

Lack of stability testing documentation

The FDA was also concerned about the stability data serving as the basis for the three-year shelf life of the analgesic declared on the packaging. The manufacturer was unable to provide this documentation, so the FDA stated in its Warning Letter that no stability testing programme exists from which stability data can be obtained to support the medicinal product's shelf life. This stability testing programme is missing not only for the analgesic but also for the hand disinfectant manufactured by the company.
For this disinfectant, there was also no testing for contamination of the ethyl alcohol used, nor was there any identity testing of other ingredients.

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The Impurities Forum Part I and II
3./4. November 2021

Beta-lactam production

Beta-lactam derivatives, which are classified as highly potent APIs, are also manufactured at this site. Due to the strong allergic potential of beta-lactams, the FDA requires a closed area (containment) for the production of this class of APIs, as well as special protective measures described in the guidance "Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross Contamination". Because of the risk of cross contamination, the FDA is very critical regarding the manufacture of beta-lactams and other drugs in the same manufacturing building or facility. The FDA could not see in the company's documentation that complete segregation and prevention of cross contamination is ensured and lists this in the Warning Letter as a further GMP deficiency at this site.

Please also see the FDA'S Warning Letter to  Laboratorio Pharma Internationa for more information.

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