GMP News - Analytical Quality Control

In the Ph.Eur. Supplement 11.4, the EDQM announces the deletion of the test for nitrate in Water For injection (WFI) and Purified Water if the test for conductivity meets the pharmacopoeial requirement for WFI. In addition, the use of recombinant factor C (rFC) to test for bacterial endotoxins will be allowed. Find out more about the changes in the Ph.Eur. Monographs Water for Injection (0169) and Purified Water (0008).

In the Pharmacopeial Forum, PF 49(5), two USP chapters related to volumetric apparatus were published for comments. It is proposed to make several changes in Chapter <31> Volumetric Apparatus. Furthermore, a new general chapter <1331> Use and Calibration of Volumetric Apparatus has been developed.

In recent months, the awareness for the impurities diethylene glycol (DEG) and ethylene glycol (EG) in pharmaceutical products was increased due to several FDA Warning Letters. We have reported on different examples where manufacturers failed to conduct proper identity testing of glycerin and other high-risk components. Now two more Warning Letters have been published, which also deal with this issue.

In the Pharmacopeial Forum, PF 49(5), a proposal of a revised USP General Chapter <701> Disintegration has been published for comments. The chapter was updated as part of the process of international harmonization of the European, Japanese, and United States pharmacopeias. The comments period runs from 01 September to 30 November 2023.

More and more authorities are trying to create regulations for the production of new technologies by publishing guidelines. In this case, the European Medicines Agency (EMA) is asking for assistance in developing a guideline on the manufacturing of mRNA vaccines.

The World Health Organization (WHO) has published a draft working document entitled WHO Biowaiver Project - Prioritization exercise of active pharmaceutical ingredients for cycle VI (2024) and preliminary results from cycle V (2023). The deadline for submitting comments is 10 September 2023.

The USP adopted the new general chapter <1567> Pyrrolizidine Alkaloids as Contaminants. Twenty-eight PAs are selected to be monitored and manufacturers of herbal medicinal products should use a risk-based approach for determining appropriate limits and testing requirements.