Joint Audit Programme

The Joint Audit Programme (JAP) forms an essential part of the quality system adopted by good manufacturing practice (GMP) inspectorates in the European Economic Area (EEA), aiming to ensure consistency of GMP standards and a harmonised approach throughout Europe.

A quality systems framework for GMP Inspectorates is part of the Compilation of Community Procedures on inspections and exchange of information and referred to in Article 3.1 of Directive 2003/94/EC.

The quality system requirements make reference to audits. The JAP was established as part of the work of the GMP/GDP Inspectors Working Group.

Joint audits are expected to lead to an improvement of the assessed authorities and enable national auditors to transfer experiences gained during the audits to their national inspectorates. These joint visits establish and maintain mutual confidence among European inspectors. Possible exposure of weaknesses and deficiencies allows the authorities to improve their quality system.

The JAP also contributes to the training of inspectors. The development of a training programme for auditors has made good progress and training of auditors takes place as required.

The EEA JAP and the Pharmaceutical Inspection Cooperation Scheme (PIC/S) have agreed to use the evaluation guides developed by Health Canada as the basic auditing tool. This guide has been adapted to European Union legislation, EEA, PIC/S and mutual recognition agreement (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 the:

• auditing schedule of their relevant programmes to ensure best use of resources;
• outcome from visits.

A subgroup of the GMP/GDP Inspectors Working Group, the Compliance Group, is responsible for:

• overseeing the audit programme;
• planning the audits;
• reviewing the outcome;
• coordinating follow up of any corrective and preventive actions.

The group carries out its activities in liaison with the concerned audit team.

It reports to the GMP/GDP Inspectors Working Group and prepares the annual report to the Heads of Medicines Agencies (HMA).

For more information, see:

• Compliance Group mandate: Joint Audit Programme for EEA GMP Inspectorates

The audit programme, its procedures and templates below form the complete set of documents used in the JAP.

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Evaluation guide for good-manufacturing-practice regulatory compliance programme: Audit checklist

Reference Number: EMA/INS/GMP/119415/2023

Annex to the evaluation guide for good-manufacturing-practice regulatory compliance programme: Audit checklist

Reference Number: EMA/INS/GMP/119414/2023

Joint audit programme for EEA GMP inspectorates: Programme

Reference Number: EMA/618050/2015 Rev.2

Joint audit programme for EEA GMP inspectorates: Procedure

Reference Number: EMA/694531/2017 Rev. 3

Joint audit programme for EEA GMP inspectorates: Audit plan

Reference Number: EMA/544128/2018 Rev.1

Joint audit programme for EEA GMP inspectorates JAP: Audit notification template

Reference Number: EMA/INS/931781/2022 Rev. 3

Audit checklist - Interpretation guide

Reference Number: EMA/92823/2021

Joint audit programme for European Economic Area GMP inspectorates: Audit report template

Joint audit programme for EEA GMP inspectorates: Confidentiality agreement for audits

Reference Number: EMA/167084/2018 Rev.1

Joint audit programme for EEA GMP inspectorates: Procedure for observing inspections

Reference Number: EMA/617616/2015 Rev. 2

Joint audit programme for EEA GMP inspectorates: Observed inspection checklist

Reference Number: EMA/170408/2018 Rev.1

Joint audit programme for EEA GMP inspectorates: Follow-up on CAPA implementation