Working Group on Product Testing (WGPT)

In support of the efforts of the EMRN with regard to the public and animal
health, the “HMA working group on Product Testing” is given the mandate by the HMA to implement the recommendations of the Product Testing Task Force (PTTF) for the quality control of MRP and DCP products.Major elements of its endeavours will be a rational use of resources and a risk based approach in defining which medicinal products should be tested for the benefit of patients.

AT, CZ, DE, DK, FI, FR, GR, NO, PT, SE, SI, UK. Experts from Official
Medicines Controls Laboratories (OMCLs), the Quality Working Party at
the EMA and representatives of the European Directorate for the Quality of
Medicines (EDQM) and the EMA Inspectors Working Group.

Mr. Miguel Bley (FR)
Tel.: (+33) 1 55 87 30 38
Fax.: (+33) 1 55 87 30 53
E-Mail: Miguel.BLEYnoSpam@noSpamansm.santenoSpam.fr

The HMA Working Group on Product Testing has been working since the adoption of its mandate by HMA in November 2008 on principles for the improvement of quality control of medicines through the sharing of information and work among EEA regulatory authorities and through the strengthening of cooperation between inspection, assessment and OMCLs within the European Medicines Regulatory Network.

One of its goals has been to explore the possibility for future evolution of the programs of product testing of MRP/DCP authorised products already in place, making concrete proposals for further improvements with a view to increasing the number of Member States that benefit from the program in terms of resource savings and to promote the use of more comprehensive information for better risk-based inspection and assessment.

The working group believes that mutual recognition of control results between Competent Authorities is one of the key components of a collaborative approach to the sampling and testing of medicinal products between EEA regulatory authorities.

At its October 2009 meeting in Uppsala, HMA supported the risk-based approach for selection of MRP/DCP products for testing and endorsed the document on Mutual Recognition of Control Results.

The document has been presented at the OMCL's Annual Meeting in May 2010 for implementation of its principles.

Principles for mutual recognition of control results| pdf

In July 2008, under the French Presidency, HMA decided to establish a Working Group on Product Testing (HMA WGPT). Its mandate was adopted at the November 2008 HMA meeting and its chair, Jean Marimbert, head of Afssaps-France was confirmed at the January 2009 HMA meeting under Czech Presidency. The working group met for the first time on 27 April 2009.

Experts from EU/EEA regulatory authorities on assessment, inspection, and laboratory control were nominated by heads of agencies to join the working group and representatives of the European Directorate for the Quality of Medicines (EDQM) and the EMEA were also invited to join. The working group will liaise with the Quality Working Party (QWP), the GMP/GDP Inspectors Working Group (GMDP IWG) and the Pharmacovigilance Working Party (PhVWP).

The HMA WGPT Mandate highlights the opportunity for improvement of the product quality surveillance of MRP/DCP authorised products through the sharing of information and work among EU regulatory authorities and through the strengthening of cooperation between inspection, assessment and OMCLs within the Network.

In this context the mandate of the working group indicates that risk-based approaches adapted to product categories and to different risk categories, taking into account all signals from assessment, pharmacovigilance, inspection, and product testing should be considered, as well as scientific, regulatory and administrative issues related to mutual recognition of product testing between Member States.

A number of tasks are included in the mandate and the group decided to set priorities and agreed to adopt a step-by-step approach. It focused on the following areas:

• Risk-based criteria for the selection of products for testing
• Mutual recognition of control results
• Mapping of existing alert and reporting systems
• Improvement of the MRP/DCP EDQM Database
• Increase of API quality control in MRP/DCP

The working group has the benefit of experiences with risk-based selection of products for testing developed by the OMCL Network under the coordination of EDQM for MRP/DCP authorised products and by the EMEA for Centrally Authorised Products (CAP) and will use this knowledge to develop proposals for risk based sampling and analysis, using the information and intelligence gained from assessment and inspection.

It will explore the possibility for future evolution of the programs of product testing of MRP/DCP authorised products already in place making concrete proposals for further improvements with the aim to increase the number of Member States that benefit from the program in terms of resource savings and of use of more comprehensive information for better risk-based inspection and assessment. It will seek for HMA support of its proposals.

Proposals would include improvement of risk-based selection criteria and of tools for the sharing of information relevant for risk management as well as the IT support to facilitate access to the information. It would also make recommendations on mutual recognition of control results and ways to improve the quality surveillance programme for APIs, with a view to improving the management of the supply chain.

It is not in the remit of this working group to define lists of products to be tested or inspected.This is the responsibility of the national laboratories within the OMCL Network and national inspectorates.