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 2008, the following activities were carried out within the OMCL Network as part of the QA programme:

During the year 2008, twelve MJA (quality audits) and one MJV (quality inventory visits), which are peer reviews carried out by experts from OMCLs, have been performed in the OMCL Network. For 2009, ten MJA and one MJV are already planned.

In total, since the beginning of the QA programme (December 1997), fifty-five MJA, forty-six MJV, two Tutorials and eleven 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.

QA Guidelines

All guidelines have been updated

(26/10/07) To download all the quality assurance guidelines for the OMCL Network, please go to our 'Quality Assurance Activities Guidelines' webpage.

Training courses for the OMCL Network

In 2008, a training course on the use of the computer program 'CombiStats' was organised by EDQM on 6th and 7th November. Two additional training sessions are planned for 22-23 January and 2-3 April 2009. For the time being these sessions are only open to OMCLs but it is intended that other users may attend them in future.

In 2007, the EDQM has organised 2 training courses on Basic Quality Assurance, the first one takes place in Vienna on 25 & 26 September (53 participants registered), and the second one will take place in Rabat (Morocco), on 27 & 29 November 2007 (co-organised by WHO, for French speaking OMCLs).

In 2006, the EDQM organised 3 training courses: one training course dedicated to quality assurance in the biological field, and 2 training courses for new auditors of the MJA/MJV scheme of the OMCL Network.

Additional Information and Downloads

OMCL Activities

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