News about GMP/cGMP

07.08.2020

EMA: MRA partners may participate in JAP audits as co-auditors

As of July 2020 the EMA (European Medicines Agency) has amended the European "Joint Audit Programme, JAP". These adaptations enable regulatory authorities from third countries with an existing EU-MRA (Mutual Recognition Agreement) to participate as co-auditors in JAP audits of EEA GMP inspectorates.

The background:
The JAP, as a joint European audit programme, covers all GMP inspectorates of the EEA in the field of human and/or veterinary medicinal products including active substances. It is an essential part of the GMP inspectorates quality assurance system referred to in Directive 2003/94/EC and adopted as part of the Compilation of Union Procedures on Inspections and Exchange of Information.
Based on this harmonisation of inspection standards within the EU, foreign regulators put their trust  into European GMP compliance systems. By giving EMA's overseas partners a more active role in the JAP audits, confidence in European inspection standards should now be further strengthened.

What is new?
EU MRA partners can be invited to participate in certain "re-audits" if they wished. However, this is limited to the role of an observer or co-auditor. The role of the lead auditor remains in European hands. In order to participate, MRA partners must sign a confidentiality agreement and fill in a declaration of interest and a curriculum vitae. During the audit, MRA partners may raise concerns, but are not allowed to intervene further in the decision of the original audit team.


Source:

EMA: Joint Audit Programme

EMA: Joint Audit Programme: Procedure



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