Thematic audits at wholesalers by FAMHP

Thematic audits at wholesalers by FAMHP

Belgium In the context of the transparency policy conducted by the FAMHP, the FAMHP announced thematic audits starting from March 2022 at wholesalers in medicines for human use. These inspections will be unannounced. The inspections will focus on the obligations of...
Revision of the PIC/S GMP Guide: Annex 13 and Annex 16

Revision of the PIC/S GMP Guide: Annex 13 and Annex 16

Europe At the end of January, EU Regulation 536/014 “Clinical trials” went into force. The entry into force of this Regulation resulted in the parallel updating of some international guidelines. In particular, a new version of the GMP Guide PE016 was...
Revision of the PIC/S GMP Guide: Annex 13 and Annex 16

News on the various Mutual Recognition Agreements (MRAs)

Europe On 19 April, the “Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2021” was published. This annual report of the GMP/GDP Inspectors Working Group (GMP/GDP IWG) gives a short but good overview of what was...