Joint Action on quality of medicines and implementation of the pharmaceutical legislation/strategy - Proposal

ongoing

The Joint Audit Programme (JAP) for Good Manufacturing Practices (GMP) inspectorates is an important tool for continuous improvement, ensures consistency of GMP standards and a harmonised approach within EU/EEA in line with the Compilation of Union Procedures on Inspections and supports confidence building within the EU/EEA and with other authorities. In addition, the Joint Audit Program serves as a fundamental basis for mutual recognition agreements with 3rd countries, such as the United States, Canada and probably the UK as well as to show equivalency with the PIC/S Joint (Re)Assessment Programme. Due to the need to increase activities targeting all Member States and EEA competent authorities for human and veterinary medicines, the overall objective of the project is to foster joint efforts in inspection and audit trainings including capacity improvement (e.g. increasing the number of qualified JAP auditors), and to support the joint audit program. Considering the importance of the JAP, all member states should get the opportunity to participate as auditors in the program to further strengthen the EU medicines regulatory network and to ensure the harmonised oversight of the quality of medicinal products. The costs associated with the JAP are a burden for several of the member states. Compensation of expanses by HaDEA / direct grant by the joint action program should increase acceptance of the JAP and preparedness to take part actively. Regarding the training of GMP inspectors, the goals should be developed in coherence with the PIC/S Inspectorate’s Academy (PIA) which has been created for ensuring harmonisation in training and qualification processes for GMP inspectors. This is critical for the development of the mutual reliance on inspection report and so, ensuring EU patient safety and saving of resources for EU NCA. The action supports the EC policy priority to implement the Pharmaceutical Strategy for Europe.