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In the Pharmacopeial Forum, PF 51(5), a corrected version of the Stimuli article entitled "Characterization of Apex Vessel Geometries and Irregularities", originally published in PF 51(1), was made available.
PharmaLab 2025 continues to expand its range of current topics for Europe and beyond. Accordingly, several new tracks will be added this year, particularly in the field of analytics. The ECA Analytical Quality Control Group (AQCG) will organise a dedicated one-day conference track.
Sampling of raw materials, intermediates and finished products is a critical quality-related activity that directly affects product quality, patient safety and GMP compliance. This raises a frequently discussed question in our GMP training courses: Who is actually permitted to perform sampling – and in particular, is production personnel allowed to do so?
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.
The comment periods for the USP chapters 'Balances <41>' and 'Weighing on an Analytical Balance <1251>' closed at the end of 2024. In the meantime, both chapters have been finalised and are now available for viewing. Both documents are set to become officially valid in February 2026.
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>.
In a Warning Letter sent to an american manufacturer in June, the FDA documents a whole list of deficiencies, ranging from a lack of testing of the components used to incorrect or faulty approvals, claims, and listings.
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.
On 12 August 2025, the U.S. Food and Drug Administration (FDA) published a Warning Letter to a U.S.-based manufacturer of over-the-counter (OTC) drug products. During an inspection, the investigator observed several specific CGMP violations.
