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Quality Management (QM) Programme

These activities involve the General European OMCL Network only.

Background

The quality management (QM) programme within the General European OMCL Network started in 1997 with a two-year pilot phase. A common approach for developing and implementing Quality Management systems (QMS) in all OMCLs of the Network had been agreed upon. This was especially important due to the increasing exchange of results and data (e.g. batch release of biologicals, market surveillance of centrally authorised products) among members. Since 1999, work in this area has intensified. It was decided to adopt a specific assistance and maintenance programme for QMS and to harmonise the quality management policies of the OMCLs. It was further agreed to refer to the ISO/IEC 17025 quality standard.

Activities

  • Mutual Joint Visits (MJVs)
    They are organised by the EDQM. These aim to advise and help OMCLs implement and/or improve their quality management systems.
  • Mutual Joint Audits (MJAs)
    MJAs of OMCLs are carried out by experts, from the Network, trained in Quality Management. These check that OMCLs quality management systems comply with the requirements laid down in ISO/IEC 17025, in the General European OMCL Network Quality Management Guidelines and in the European Pharmacopoeia. They take place on a routine basis.
  • Education Activities
    Education activities such as training visits and training courses educate OMCL staff in QM and/or on technical topics related to the implementation and improvement of OMCLs quality management systems.
  • Quality Management Guidelines
    They have been drafted by experts from the Network. They aim to support laboratories in implementing the ISO/IEC 17025 requirements, while taking into account the specific OMCL environment. From a legal point of view a guideline is not binding, but deviations from its content require a sound (and, if applicable, scientific based) justification.
  • Recommendation Documents
    They have been drafted by experts from the OMCL Network. Similar to the QM-Guidelines they shall support laboratories in implementing the ISO/IEC 17025 requirements. They provide guidance for OMCLs of the GEON or a specific network without binding character.
     

Following meetings with representatives of the European co-operation for accreditation (EA) and presentations given at meetings of the EA Laboratory Committee, the EDQM has been accepted as “Recognised Stakeholder” of the EA in 2013. This recognition will foster future co-operation, exchange of information and mutual acceptance of audit results. The EA now officially supports the performance of joint audits between National Accreditation bodies and EDQM/OMCL experts. The EA confirmed the use of the EDQM’s quality management guidelines in QMS audits of OMCLs by accreditation bodies.

In 2017 an EA-EDQM joint document has been published on the EA website: EA-INF/15:2017 Joint EA - EDQM Communication regarding cooperation when carrying out (joint) audits/assessments in Official Medicines Control Laboratories.

For a list of these guidelines, click HERE.

Also the members of the OMCL Network officially support the idea of joint audits and express this position in the paper “Complementary Mutual Joint Audits in OMCLs accredited against ISO/IEC 17025”.

Achievements in 2018

Quality Management programme

The publication of the new ISO norm 17025:2017 in November 2017 required the OMCLs to implement the new clauses within a transition period of 3 years. In this respect, the Network coordinated by the EDQM, supported the OMCLs organised a two-days training session for OMCL representatives/auditors followed by a one-day workshop specifically dedicated to MJA auditors. In addition, self-assessment tools were elaborated to evaluate the impact of the revised norm on the OMCL QMS documents.

Mutual Joint Audits/Visits and Training Visits

During 2018, 10 MJAs, 1 MJV and 4 Training Visits (TVs) were carried out, bringing the total number to 179 MJAs, 52 MJVs and 28 TVs/Tutorials since the programme was launched in 1997.

OMCL Network Quality Management Guidelines

Five QMS Guidelines were revised and published in 2018 namely “Qualification of Equipment – Core document” and related  “Annnex 1 - Qualification of Liquid Chromatography Equipment”, “Annex 6 - Qualification of Piston Pipettes”, and “Annex 7 - Qualification of Mass Spectrometers”, as well as “Validation of Computerised Systems” and related Annexes 1 and 2.

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