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EU: EMA clears mutual recognition partners to co-audit GMP inspectorates

2020/08/07  EMA

The scope of the Joint Audit Programme (JAP) is to verify the implementation of relevant provisions of European Union (EU) legislation into national laws, authorisation/licensing system for manufacturers and importers, Good Manufacturing Practices (GMP) compliance certification, administration of inspections, inspectorate, resources, complaints, rapid alerts including laboratory support, enforcement and internal quality assurance. The JAP covers all European Economic Area (EEA) GMP inspectorates in the field of medicinal products for human and veterinary use, including active substances.

The audit programme forms an essential part of the GMP inspectorate’s quality system as referred to in the legislation (Directive 2003/94/EC) and adopted by GMP inspectorates as part of the Compilation of Union Procedures on Inspections and Exchange of Information. It ensures harmonised inspection standards and a harmonised approach to practical interpretation of GMP on the basis of European Union legislative requirements to support mutual recognition of inspection outcomes.

Additionally, and in order to satisfy requirements laid down in mutual recognition agreements (MRAs) and other legal agreements between the EU and some third countries, all member states have agreed to implement harmonisation of inspection practices and compliance procedures. This is particularly important in order to preserve confidence in the GMP compliance systems among MRA and other partners as agreed in the MRA and partners’ maintenance programmes.

In order to meet these challenges and to preserve the confidence achieved both within the EU and at MRA level, the Heads of Medicines Agencies (HMA) group decided in October 2000 to set up a JAP with a view to evaluate their inspection systems, with the mission, wherever necessary, to implement corrective actions likely to guarantee the quality equivalency of these systems. Given the significant increase in the number of inspectorates responsible for medicinal products for human and veterinary use to be audited since the start of the JAP and the need to make best use of scarce resources, the principles of quality risk management have been included in the way it plans and conducts its audits and in the writing of reports. The JAP will also share inspection best practices with other EEA inspectorates, where possible and agreed with the auditee, in order to improve the effectiveness of the inspectorate network.

The HMA group has signed a letter of agreement with Pharmaceutical Inspection Co-operation Scheme (PIC/S), which entered into force on 15 August 2016, by which HMA and PIC/S agree to co-operate in exchanging information in the context of the EEA JAP of GMP Inspectorates and the PIC/S Joint Reassessment Programme (JRP) of Participating Authorities.

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