HMA/EMA Joint Audit Programme (JAP)

HMA (Joint Human and Veterinary) established an audit programme among the GMP inspectorates of all EEA GMP human and veterinary medicines agencies known as the Joint Audit Programme (JAP). The programme has the following broad aims:

• To conduct periodic audits to verify the implementation and equivalence of EEA GMP inspectorates with relevant provisions of European Directives into national laws. This includes authorisation / licensing system for manufacturers, GMP compliance certification, administration of inspections, inspectorate, resources, complaints, rapid alerts including laboratory support, enforcement and internal quality assurance.
• To contribute to the development of a world-class GMP medicines regulatory system based on a network of agencies operating to best practice standards.
• To ensure harmonised inspections 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 across the EU.
• To satisfy requirements laid down in mutual recognition agreements (MRAs) between the European Union and to preserve confidence in the GMP compliance systems among MRA partners.
• To satisfy the audit requirements of those member state national authorities who are also Pharmaceutical Inspection Co-operation Scheme (PIC/S) participating authorities under the Joint Reassessment Programme (JRP).

JAP is based on assessment of the systems and processes in individual agencies against a set of indicators which have been harmonised between MRA partner countries and PIC/S in the following areas:

• Legislative and Regulatory Requirements and Scope
• Regulatory directives and policies
• GMP Standards
• Inspection resources, procedures and performance standards
• Enforcement powers and procedures
• Alert and crisis systems
• Analytical capability
• Surveillance programme.

The assessment is also an opportunity to identify strengths and best practices in inspectorates and any opportunities for improvement; inspectorates are encouraged to install suitable best practices in order to enable an improved operation of the network of agencies.

MRAs are in place to:

• Optimise the use of inspection resources
• Grant mutual recognition of reports, certificates, authorisations issued by national authorities
• Reduce technical barriers to trade
• There is an agreement between HMA and PIC/S where the JAP and JRP audits are considered equivalent in order to avoid duplication of audit work, the agreement also forms the basis of joint training for inspections and audits.

The JAP audit programme is run by the Compliance Group.

The Compliance Group is composed of representatives of AT, FI, DK, DE, ES, GR, IT and NO.

EMA provides secretariat support to the group.

Contact  Points:

Giampiero Lorenti (Chair), AIFA, IT
e-mail: G.LorentinoSpam@noSpamaifa.govnoSpam.it

JAP Secretariat (EMA)
e-mail: JAPnoSpam@noSpamema.europanoSpam.eu

The Compliance Group, a sub-group of the EMA GMDP Inspectors Working Group, has been established to develop the programme and oversee its operation. The Compliance Group, in conjunction with international partner countries (MRA and PIC/S) has drafted the common checklist used in the assessment, devised the methodology, and is also jointly responsible for training the auditors.

The main goals of the Compliance Group are to oversee the audit programme, plan the visits, review the outcome and coordinate follow-up of any corrective measures. The GMP inspection services group at the EMA adopted the mandate for the Compliance Group and nominates its members. In detail, the JAP related responsibilities of the Compliance Group include the following:

• to plan and co-ordinate visits as lined out in this programme
• to monitor the visits
• to review the outcome of the visits
• to coordinate follow up of any corrective measures
• to discuss and resolve where possible any major problems that occur and to present to the GMP Inspection Services Group any issues which cannot be resolved
• to ensure that documentation of the programme is relevant and up to date
• to report at the meetings of the GMP inspection services Group
• to provide annual reports to the Heads of Medicines Agencies
• to define and monitor training courses for auditors
• to discuss and exchange information with PIC/S compliance group on JRP with respect to mutual recognition of the audit results
• to exchange information with other regulatory bodies (e.g. WHO) involved in audits concerning
• GMP inspectorates

It can be contacted at JAPnoSpam@noSpamema.europanoSpam.eu

Logistical support for the scheduling of visits is by the Compliance Group Secretariat provided by the European Medicines Agency (EMA) and support for the training workshops is provided by the EMA.
 

The JAP methodology includes both self-assessment and on-site assessment.

Self-assessment enables agencies to assess their own performance against the checklist indicators.

The on-site assessment allows each inspectorate to be visited by teams of specially trained auditors (drawn from a pool of trained auditors from other EU, MRA and PIC/S inspectorates) for an independent audit against the checklist indicators.

The outcome of each audit is a report produced by the audit team and agreed with the visited agency which proposes or plans remedial actions on indicators as necessary. The Compliance Group monitors the progress of corrective actions after the audit, escalating any critical observations as required to the EMA GMDP Inspectors Working Group, and to the HMA if deemed necessary.

The Compliance Group adopts the final report on behalf of the GMDP Inspectors Working Group. All results are stored on a central repository and a report is generated for the audited agencies which is also used to identify best practices and for improvement.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. Internationally, PIC/S brings together 49 PIC/S Participating Authorities worldwide, including the National Competent Authorities in the EU/EEA.

The HMA has a signed letter of agreement  with PIC/S (link to PDF), 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 Joint Audit Programme (JAP) of GMP Inspectorates and the PIC/S Joint Reassessment Programme (JRP) of Participating Authorities.

For more information see the PIC/S website.

The JAP programme began in 2002 with the establishment of MRAs for GMP inspection and audits by mutual recognition partner countries and coordination under the Compliance Group.  The JAP programme has a total of 44 inspectorates which require auditing. The JAP related responsibilities of the Compliance Group include the following:

• to plan and co-ordinate visits as lined out in this programme
• to monitor the visits
• to review the outcome of the visits
• to coordinate follow up of any corrective and preventive measures
• to discuss and resolve where possible any major problems that occur and to present to the EMA GMDP Inspectors Working Group any issues which cannot be resolved
• to ensure that documentation of the programme is relevant and up to date
• to report at the meetings of the EMA GMDP Inspectors Working Group to provide annual reports to the HMA
• to define and monitor training courses for auditors
• to discuss and exchange information with MRA partner countries and PIC/S compliance group
• to exchange information with other regulatory bodies (e.g. WHO) involved in audits concerning GMP inspectorates.

JAP procedures for these are located on the EMA website.

JAP audits are typically performed every 5-6 years for every member state’s GMP inspectorate(s). Additional audits may be considered as a result from previous evaluations, on the basis of significant changes to the inspectorate or specific requests from the European Commission or at the request of a Member State inspectorate.

During 2022 three JAP audits were conducted and in 2023 there were eleven JAP audits. Fifteen JAP audits are planned for 2024 and nine JAP audits for 2025.

Since November 2022, JAP Secretariat (EMA) and Compliance group are working closely with the Coordination team of the EU4H11 Joint Action to strengthen EU/EEA NCAs - Medicines Inspectorates. Joint Actions, in the framework of the EU4Health programme, provides co-financing by the European Union in form of a direct grant to member states. One of the main goals of the Joint action EU4H11  is strengthening the Joint Audit Programme (JAP). This Joint Action EU4H11 will work on optimising training and qualification processes for auditors as well as the JAP procedures for GMP inspections. Furthermore, the co-financing of costs related to JAP activities supports member states’ participation in the Joint Audit Programme. For more info, please visit this link.