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Wednesday, February 1, 2017

European Medicines Agencies and PIC/S agree on Audit Cooperation


 PIC/S & EMA


















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 authorization 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.

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Source: PIC/S GMP Compliance

GMP News, GMP guidelines, GMP Violations, GMP warnings, GMP Trends. A Public Health Global News Portal. (This story has not been edited by GMP Violations staff and is auto-generated from a syndicated feed.) Disclaimer: The Logos/Images & content posted here are belongs to respective to Authority / owners of firm. The Article posted under public health importance news.
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