NIH in line with the FDA: the topic of 3Rs, i.e., replacement, reduction, and refinement of animal testing, remains a focus. In the future, the NIH will no longer fund research projects that rely exclusively on animal testing.
Information on the selection and evaluation of disinfectants and procedures for pharmaceutical manufacturing is scarce. The classic test standards in Europe are mostly geared toward healthcare. Therefore, USP Chapter <1072>, which deals with this topic, is often used as a guide. This chapter on disinfectants and aseptics is currently being revised.
In July, the FDA published a warning letter to Exela Pharma Sciences, which, in addition to deficiencies in microbiological tests and inspections such as sterility tests, growth promotion tests and environmental monitoring, also included a whole series of other deficiencies. It was the consequence of an inadequate response to the FDA's previous 483 letter.
Various pharmacopoeias are currently revising chapters relevant to microbiology. This affects various areas, from rapid methods to potency determination for phage therapies, which is located in many microbiology departments.
Chapters with microbiological relevance are currently being published or revised in a whole series of pharmacopoeias. Chapters on rapid methods, pyrogenicity and endotoxin testing are also currently published for comment in the European Pharmacopoeia.
The 13th PharmaLab Congress from November 24-28, 2025 will take place as usual in Neuss/Düsseldorf with two pre-conference workshops and several parallel conferences. As always, it offers you the opportunity to become part of the speaker team and submit a presentation to share your knowledge with colleagues and discuss the respective experiences. So, become part of the team of speakers - and submit your proposal for a presentation via our online form.
The Professor Wallhäußer Award for Innovations in GMP and Pharmaceutical Technology will once again be presented at the PharmaCongress on 8 and 9 April in Wiesbaden. This year, 14 projects have applied for the award, with topics ranging from optimised technology to AI applications.
With the draft chapter <1110>, the USP completes its programme with recommendations on the subject of contamination control strategy, as already called for in other documents.
A manufacturer of OTC products from Mesquite, Texas received a Warning Letter from the US FDA for deficiencies in various areas ranging from microbiology and raw material analysis to cleaning and disinfection.
