Quality Systems Framework for GMP Inspectorates is part of the Compilation of Community Procedures on inspections and exchange of information and referred to in Directive 2003/94/EC Art.3.1. The Quality System Requirements make reference to audits and as part of the work of the GMP/GDP Inspectors Working Group a Joint Audit Programme (JAP) was established.
The audit programme forms an essential part of the quality system adopted by GMP inspectorates. It aims to ensure consistency of GMP standards and a harmonised approach throughout Europe. The enlarged European Econcomic Area (EEA) with around 40 GMP inspectorates emphasises the need for a consistent approach. Joint audits are expected to lead to an improvement of the assessed authorities and allow the possibility that national auditors can transfer experiences gained during the audits to their national inspectorates. Mutual confidence among European inspectors is therefore established and maintained through these joint visits. Possible exposure of weaknesses and deficiencies allows the authorities to improve their quality system. The Joint Audit Programme also contributes to the training of inspectors.
The EEA JAP and the PIC/S (Pharmaceutical Inspection Cooperation Scheme) have agreed to use the Evaluation Guides developed by Health Canada as the basic auditing tool. This guide has been adapted to the EU legislation. EEA, PIC/S and MRA audit programmes now use the same evaluation guide and this has paved the way for mutual acceptance of audit results. EEA, PIC/S and MRA partners agreed on sharing outcome from visits. It has also been agreed to share the auditing schedule of their relevant programmes to ensure best use of resources.
Training of Auditors was seen as a key element to ensure a harmonised approach to audits. The development of a training programme for auditors has made good progress and training of auditors takes place as required.
The audit programme, its procedures and templates below form the complete set of documents used in the Joint Audit Programme.
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