As part of the revision and reorganisation of the USP chapters on biological assays, the USP has now published the draft revision of chapter <111> ‘Design and Analysis of Biological Assays’. The revision was also necessitated by the contents of the new chapter <1034>.
WHO: With the publication of new guidelines, another relevant organisation is now emphasising the importance of the 3R principle in the quality control and quality assurance of biopharmaceutical products. This means that efforts in Europe and, for some time now, in the USA are now also moving in the same direction globally.
During an inspection, the FDA identified significant deficiencies in microbiological safety, as well as in the handling of deviations and maintenance, at a Swedish manufacturer. As the responses and measures taken by the company concerned were deemed insufficient, the FDA has now issued a Warning Letter.
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.
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