In the Pharmacopeial Forum, PF 51(1), two USP chapters related to volumetric apparatus were published for public comment. Based on the comments received, the proposals previously published in PF 49(5) have been canceled and replaced with new suggestions.
In the Pharmacopeial Forum, PF 51(1), a Stimuli article entitled "Characterization of Apex Vessel Geometries and Irregularities" was published. Apex vessels, previously referred to as PEAK vessels, are commonly used in dissolution experiments with Apparatus 2. The study highlights the importance of understanding the geometric variability of apex vessels and its potential impact on dissolution results.
In the Pharmeuropa issue 37.1, a proposal for chapter 2.5.45. Photoionisation detectors for the detection of hydrocarbons/oils in gases has been published. The deadline for comments is 31 March 2025.
In November 2024, the European Chemicals Agency (ECHA), joined by five European authorities from Denmark, Germany, The Netherlands, Norway and Sweden, has issued a progress update for the restrictions regarding PFAS (per- and polyfluoroalkyl substances) on their website.
In late November 2024, it was reported on the EDQM's website that the new harmonized chapter "Elemental Impurities (G-07)" of the "Pharmacopoeial Discussion Group (PDG)" was signed in June 2024.
A pharmaceutical manufacturer of OTC products in Turkey has now received a Warning Letter from the FDA due to a number of fundamental GMP violations. The inspection had taken place in May 2024.
On behalf of the ECA Concept Heidelberg regularly analyses the deficiencies in FDA Warning Letters regarding medical devices. Since medical devices can be part of a combination product consisting of a medicinal product and a medical device, these statistics are also of interest to manufacturers of these products. What did the FDA criticise in the last fiscal year?
Last year, the FDA issued a draft guidance on the risk assessment of medicinal products, biologics and combination products. The guideline has a total of 13 pages, divided into five chapters, a glossary and a sample table. It is therefore relatively straightforward. What is it about?
In November 2024, the "Team NB" published a 28-page guideline in the style of a questionnaire on the topic of "Artificial Intelligence in Medical Devices".
The European Drug Shortages Formulary (EDSForm) project aims to tackle drug shortages across Europe.