Good Distribution Practices News

The EMA has published a list of the main therapeutic groups in order to avoid shortages of medicinal products in the case of a public health emergency and thus to ensure the supply of critical medicinal products. Another EMA document defines the methodology for establishing and maintaining this list and further lists of critical medicinal products.

A proposal for USP chapter <1079.4> Temperature Mapping for the Qualification of Storage Areas has been published for comments in the Pharmacopeial Forum, PF 48(5). It will apply to every link in the supply chain, such as manufacturers, wholesale distributors and third-party logistics providers. The new chapter should be viewed in the context of the United States Pharmacopeia's (USP) efforts to build out the <1079> series of chapters on Good Storage and Distribution Practices.

The competent authority of Germany (Thuringian State Authority for Consumer Protection) has entered a new GPD Non-Compliance Report dated 21 July 2022 into the EudraGMDP database. The wholesale distribution authorisation (WDA) of the company concerned was suspended. Among other things, the authority criticized the lack of a GDP-compliant quality system.

When conducting GDP audits, it can be helpful to work with question lists. We have compiled typical questions for ocean freight operations.

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Amazon for selling unapproved drugs for mole and skin tag removal that have not been evaluated by the FDA for safety, effectiveness or quality. Amazon has 15 working days to respond and explain the specific steps that were taken to address the violations. Otherwise, legal action may result.

In the US, there is currently a lot going on in the area of GDP. In recent weeks and months, the FDA has published several new documents related to the Drug Supply Chain Security Act (DSCSA).