In December, the FDA published a Warning Letter to a manufacturer of OTC products, in which it identified deficiencies in both the handling of microbiological deviations and the validation of alternative rapid microbiological methods. The testing and analysis of raw materials used for contamination was also inadequate.
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Due to high demand, the ECA has extended its special offer of sending two additional participants free of charge for each registered participant and a two-year membership for all congress participants and PharmaTechnica visitors until 31 January. After that, the 2-for-1 offer will apply until the congress.
The British National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs), with the support of other European authorities, the FDA and industry representatives, has published a survey on MAT in pyrogen testing and is calling for participation.
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.
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>.
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.
