GMP News - Analytical Quality Control

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.

The latest valid version of the USP chapter "Balances <41>" has been substantially revised and is now posted for comment on the USP Pharmacopeial Forum website. This revision follows updates to the USP chapter "Weighing on an Analytical Balance <1251>" and the general chapter "Balances" of the European Pharmacopoeia (Ph. Eur.). Comments on this draft can be submitted until 30 November 2023.

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.

Artificial intelligence (AI) is revolutionising industry, and the pharmaceutical sector is no exception. One might think AI reaches its limits when it comes to GMP. But there are promising possibilities.