Lab

The Austrian Medicines Control Laboratory

Tasks and competences of the AGES Official Medicines Control Laboratory (OMCL)

The OMCL is member of the European Network of Official Medicines control laboratories (GEON, General European OMCL Network).


https://www.edqm.eu/en/General-european-OMCL-network-46.html

 

The main task of an OMCL is quality control of medicinal products on the legal market. For that matter the laboratory uses analytical procedures to ascertain that the properties (identity, purity, potency) of the tested samples comply with the specifications laid down in the relevant marketing authorization and the monographs of the European Pharmacopoeia.

Another very important task of the OMCL is the analysis and evaluation of samples which suspected of being illegal medicinal products.

 

To qualify for being a member of the General European OMCL Network a laboratory has to fulfill the following requirements:

 

  • Independency (no analytical services for third parties)
  • A quality assurance system according to ISO 17025 (either accredited or by means of mutual joint audits performed by the GEON)
  • Regular and successful participation in proficiency testing studies
  • Participation in the development of standards and reference materials
  • Participation in the development of monographs of the European Pharmacopoeia

 

All above mentioned criteria are fulfilled by the AGES OMCL. Moreover it is involved in many different projects playing a leading role, e.g. as scientific advisor or project leader.

 

The accreditation according to ISO 17025 is a quality standard aiming at achieving verifiable and correct results. The AGES OMCL is particularly accredited for testing methods that are mentioned in the European Pharmacopoeia. The devices used in the laboratories are state of the art and the deployed personnel is highly qualified and experienced. The AGES OMCL has access to all reference substances and standards that are necessary for performing reliable and valid results in the analysis of medicinal products. Thus, the quality of laboratory analyses is ensured on a modern and highly scientific level.

 

These properties qualify the AGES OMCL in an outstanding way for analytics of samples from the legal and the illegal market.

Created: 01.03.2009 | Page last modified: 23.01.2015

© Austrian Federal Office for Safety in Health Care
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