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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 2020

Quality Management programme

In response to the pandemic crisis, the planned audit programme was revised in March 2020. Priority was given to the non-accredited OMCLs for which the extension of the attestation expired in 2020 and the alignment with the new requirements of the ISO/IEC 17025:2017 was essential. The assessment of the Quality Management (QM) system was carried out in remote mode by videoconferencing, focussing on the new requirements of the standard.

Harmonisation of Quality Management Systems (QMS) among OMCLs and achievement of appropriate quality levels for the mutual recognition of test results among Network members (e.g. for official batch release testing of biologicals, market surveillance and falsified medicines testing) remain the main goals of the programme.

Mutual Joint Audits/Visits and Training Visits

Mutual Joint Audits and Visits (MJAs/MJVs) is the system in place within the Network to assess the compliance of OMCLs with the quality requirements laid down in ISO/IEC 17025, Network’s QM guidelines and European Pharmacopoeia. In 2020, 12 MJAs were carried out bringing the total to 192 MJAs, 53 MJVs and 28 TVs/tutorials since the programme was launched in 1997.

OMCL Network Quality Management Guidelines

During 2020, eleven Guidelines were adopted namely:

  • “Externally Provided Products and Services”
  • “Handling and use of non-compendial reference standards in OMCL Network”
  • “Management of Changes”
  • “Management of Environmental Conditions”
  • “Management of Samples”
  •  “Qualification of Equipment – Annex 2 Qualification of GC Equipment”
  • “Qualification of Equipment – Annex 3 Qualification of UV-visible Spectrophotometers”
  • “Qualification of Equipment – Annex 8 Qualification of Balances”
  • “Qualification of Equipment – Annex 10 Qualification of Atomic Absorption / Atomic Emission Spectrometers”
  • “Validation/Verification of Analytical Procedures”
  • “Risk-based Auditing Approach” (new Recommendation document)”.
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