PIC/S and European Medicines Agencies agree on Audit Cooperation

Recommendation

14-16 June 2023
Copenhagen, Denmark

The GMP-Auditor
Initial and Continuous Professional Training for GMP Auditors

Most recently, PIC/S has published a "Letter of Agreement between the EEA Heads of Medicines Agencies and the Pharmaceutical Inspection Co-operation Scheme" on their website. The objective of the agreement is the exchange of information after audits among authorities and joint trainings for GxP inspectors.

The agreement has been signed by PIC/S and the "Heads of Medicines Agencies" (HMA), a network of Heads of European Medicines Agencies responsible for the authorisation of human and veterinary medicinal products in the European Economic Area.

The information is exchanged in connection with the "EEA Joint Audit Programme" (JAP) and the "PIC/S Joint Reassessment Programme" (JRP). Both programmes are considered equivalent and will alternately accompany audits within the programmes.

The exchange of auditing schedules, also with other programmes - such as the WHO vaccination programme - is important to avoid any duplication of audits. Another key point is the joint training of inspectors and auditors. Here, the main focus is on GMP and GDP.

The agreement came into force last August and can be retrieved on the PIC/S website under Publications.