The recording of the session, a Q&A paper, and the guidance document are available in the members’ area. If you are not yet a member, you can register here for free.
The European Pharmacopoeia has published a fully revised draft of Chapter 2.4.24. Identification and control of residual solvents in Pharmeuropa 37.4 for public consultation.
The United States Pharmacopeia (USP) has announced the adoption of the revised harmonized chapter <701> Disintegration, approved by the Pharmacopeial Discussion Group (PDG).
The Analytical Target Profile (ATP) has become a central element in the development and lifecycle management of analytical procedures. But how is the ATP defined in current regulatory guidance, such as ICH Q14 and USP <1220>?
In the context of stability studies, bracketing and matrixing strategies allow for a reduction in testing effort without significantly compromising the integrity of the results – provided they are scientifically justified and documented in accordance with regulatory requirements.
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.
