GMP News - APIs and Excipients

On the website of the EDQM (European Directorate for the Quality of Medicines & HealthCare), the list of available reference standards is updated at regular intervals. It indicates which reference substances have been replaced by new batches and which standards have been removed from the list of reference substances (since January 2023) or will be deleted in the future (as of April or July 2023).

A federal court has entered a consent decree of permanent injunction against a Florida-based drug importer and distributor. It prohibits the company from distributing active pharmaceutical ingredients (APIs) not manufactured, processed, or held in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). This was preceded by a legal dispute with the U.S. Food and Drug Administration (FDA).

In December 2022, the U.S. Food and Drug Administration (FDA) has announced the availability of a draft guidance for industry entitled "Statistical Approaches to Establishing Bioequivalence". Comments and suggestions could be submitted until 04 February. After this deadline, the comments received have now been published.

In January you could read about the publication of the revised ICH Q9 guideline. What is new with regard to quality risk management (QRM)?

The U.S. FDA has concluded that a new regulatory pathway for CBD is needed that balances the desire for access to CBD products with the regulatory oversight needed to manage risks.

Furthermore, the "Falsified Medicine Directive (2011/62/EU)" requires a "Written Confirmation" for the import of active pharmaceutical ingredients (APIs) from third countries. The APIs imported from countries on the so-called "White List" are an exception to this. In future, Canada will also be listed on this "White List".

There is currently an ongoing discussion about the microbiological quality requirements for medical Cannabis depending on the route of administration. To move forward authors from the FDA recently published an article about a microbiological study of bulk Cannabis.