News

Two new GDP Non-Compliance Reports from Austria and Ireland have been published in the EudraGMDP database. Both authorities document violations of the EU GDP guidelines and have revoked the Wholesale Distribution Authorisation (WDA) of the respective companies.

The Parenteral Drug Association (PDA) has published the results of its 2025 Transportation Validation Benchmarking Survey. The survey aimed to gather industry benchmarking data on transportation qualification strategies within the pharmaceutical and biopharmaceutical industry.

The United States Pharmacopeia (USP) is considering a revision to its definition of controlled room temperature (CRT), aligning it with the ranges recommended by the Japanese Pharmacopoeia (JP), European Pharmacopoeia (EP), and World Health Organization (WHO). A Stimuli article published in the current Pharmacopeial Forum, PF 51(3), highlights that the existing discrepancy between USP’s CRT definition (20°–25°C) and the JP, EP, and WHO standards (15°–25°C) leads to inconsistencies in drug storage practices and increased energy consumption.

A new article titled “A Voyage in Good Distribution Practice (GDP): The Aviation and Marine Sectors” has been published on the MHRA Inspectorate blog. In this post, the Medicines and Healthcare products Regulatory Agency (MHRA) outlines key regulatory expectations, licensing requirements, delivery procedures, and specific considerations for recalls and repackaging when supplying medicines to the aviation and marine sectors – two environments that present unique logistical and compliance challenges.