Quality Assurance Activities

General system for Quality Assurance (QA)

A common approach on developing and implementing QA systems in all OMCLs of the network has been agreed. This is especially important due to the increasing exchange of results and data (batch release of biologicals, market surveillance of centrally authorised products, etc.). Work in the area of quality assurance systems has intensified since 1999. This resulted in the adoption of a harmonisation programme for the quality assurance policies of all the members of the network and a specific assistance and maintenance programme for a quality assurance system in the network. Specific guidelines have been elaborated. Within the network it has been agreed to refer to the ISO/IEC 17025 quality standards.

The Audit Programme

Procedures for Mutual Joint Audits (MJA), making use of experts from the network and trained in QA, have been elaborated and a programme of auditing the different OMCLs of the network is running.
In addition, Mutual Joint Visit, Tutorials and Training Visits are organised by EDQM with the aim of giving advice and helping OMCLs implementing and/or improving their quality management systems.

During the year 2007, the following activities were carried out within the OMCL Network as part of the QA programme:

During the year 2007, 6 MJA have been performed in the OMCL Network and 2 MJA are planned until the end of 2007.
Thirteen MJA are already planned for 2008.

In total, since the beginning of the QA programme (December 1997), 41 MJA, 45 MJV, 2 Tutorials and 11 Training Visits have been carried out in the OMCL Network.

OMCL Network Quality Assurance Guidelines

(01/07/08) A new annex of the OMCL Network guideline 'Qualification of equipment' was adopted at the OMCL Network annual meeting in June 2008. It deals with the qualification of automatic titrators and is applicable as of 1st August 2008.

Collaboration with EA
Discussions with representatives of the European co-operation for Accreditation (EA) concerning the recognition of the contribution of OMCLs in setting up Quality Management Systems within their domain are ongoing. In 2005, the following guidelines/documents were approved by EA as recommendation documents to be used in the context of quality system audits of OMCLs and are now also available on the EA website:

• Validation of analytical procedures,
• Scope of accreditation of Official Medicines Control Laboratories,
• Uncertainty of measurement: policy on the estimation and application of uncertainty in analytical measurement (compliance testing).

Where appropriate in the context of pharmaceuticals the EDQM/OMCL Network intends to present further guidelines for approval and use by the EA members.