In October 2024, the IPEC (International Pharmaceutical Excipients Council Europe (IPEC Europe) asbl) announced on its website the new version 3 of its GDP guide 'Good Distribution Practices Guide for Pharmaceutical Excipients'.
The United States Pharmacopeia (USP) has issued a pre-posting notice to inform of the anticipated publication of General Chapter <1079.2> Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products. This provides early access to the chapter due to strong regulatory interest in several Climatic Zone IVb countries.
We recently reported on two GDP Non-Compliance Reports issued by the Romanian authorities. Now, an additional report concerning a Romanian wholesaler has been published in the EudraGMDP database.
Swissmedic has updated the Directive "Conduct of inspections of establishments manufacturing or distributing medicinal products or collecting blood". Version 4.0 was approved on 21 October 2024.
BioPhorum recently published a new document entitled "Restarting the inbound supply chain: a BioPhorum Supply Partnering and Relationship Management position paper".
The Competent Authority of Romania (National Authority Of Medicines And Medical Devices) has issued two new GDP Non-Compliance Reports related to human medicinal products in the EudraGMDP database.
The UK Medicines & Healthcare products Regulatory Agency (MHRA) has published a new "Wholesalers & manufacturers guidance following agreement of the Windsor Framework". The text contains guidance for wholesalers, Responsible Persons (RPs) and Responsible Persons for Import (RPis) in order to implement the arrangements of the Windsor Framework for human medicines.
Swissmedic has made the new SwissGMDP database publicly available. The database lists all establishment licence holders domiciled in Switzerland, as well as all the operating sites and activities that are authorised. It is also possible to consult the GMP and GDP certificates.
During several GDP events organized by the ECA, the wish came up to compile a list of relevant abbreviations used in the GDP environment. The overview, initially published a few months ago, has now been further expanded.
Swissmedic has published an updated version of the Technical Interpretation "Responsible Person: Requirements (I-SMI.TI.17e)", which includes numerous clarifications. Although compliance with the previous version typically remains sufficient, some situations may require immediate action from license holders. The new interpretation is effective immediately.
