Wednesday, 4 October 2023 13.00 - 17.00 h
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter dated 18 October 2022 to a manufacturer of over-the-counter (OTC) drug products, including hand sanitizers. The authority reviewed the records the company submitted in response to a request for records and other information. Based on these documents, the FDA found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.
In the Warning Letter, the FDA once again highlights the importance of analytical testing of incoming raw materials, finished drug product testing and stability testing. These requirements also apply in full to manufacturers of hand sanitizers.
The firm did not adequately test each lot of incoming raw materials for identity. In this context, the FDA mentions in particular ethanol and isopropyl alcohol. Furthermore, the company did not test for methanol on any incoming lots of ethanol and isopropyl alcohol.
The FDA points out that each manufacturer has "to sample, test, and examine drug components before use in production to assure adequate quality, including testing for the presence of methanol in ethanol and isopropyl."
There was a lack of analytical tests not only for raw materials but also for finished drug products. Based on the records and information provided, no adequate finished drug product testing on all drug products was conducted. According to the batch records, the company's hand sanitizer drug products were only tested for weight, density, color, viscosity, and smell.
The FDA says that "full release testing, including strength and identity testing of the active ingredient, must be performed before drug product release and distribution."
Finally, no documents could be provided to support the expiry periods of the firm's hand sanitizers.
According to the FDA, only with appropriate stability studies, there is a scientific evidence to support whether the drug products meet established specifications and retain their quality attributes through their labeled expiry.
For more detailed information, please see the Warning Letter to McConnell Labs Inc.