The Qualified Person (QP) often reviews the batch documentation personally prior to certification of a batch. But is the QP obliged to do so? No, because this is not a

With the start of the application of the EU CTR on 31 January 2022, the MHRA (UK Medicines and Healthcare products Regulatory Agency) has launched a public consultation on proposals for legislative changes for

For companies with a valid establishment licence for the manufacture of medicinal products and transplant products, Swissmedic issues GMP Certificates on request. GMP Certificates from Swissmedic show the date of the inspection

The final version of Annex 21 to the EU-GMP Guidelines (“Importation of medicinal products”) has been published in EudraLex Vol. 4. The draft was already published for comments in March 2020. Approximately

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised its good manufacturing practice (GMP) guide (PE 009-16, Annexes) to reflect the EU Clinical Trials Regulation 536/2014 (CTR), which came into application on 31 January 2022.