PTS229 on Osmolality has been postponed to the first quarter of 2023. In 2022, 4 studies were proposed in the physico-chemical area: PTS225 on Optical rotation, PTS226 on Liquid chromatography, PTS227 on Determination of N-nitroso-dimethylamine (NDMA) in valsartan tablets and PTS228 on Refractive index. Participation is free for members of the General European OMCL Network but subject to payment for non-members. Following registration, any control laboratory can participate. The EDQM organises, co-ordinates and manages the scheme. Who Organises the Scheme and Who Can Participate? This helps build mutual trust between OMCLs - an important component of an effective common system for the quality control of medicines.Ī number of studies are organised each year in the physico-chemical area and in the area of biologicals. Participation in the scheme provides laboratories with an objective means for assessing and demonstrating the reliability of their data. With this in mind, PTS studies are regularly carried out on basic methods of analysis in the biological and physico-chemical fields (including on methods used in pharmaceutical technology such as dissolution testing) in the framework of ISO/IEC 17025-the standard chosen by the General European OMCL Network. Primarily, the scheme aims to ensure that the results obtained within the General European OMCL Network are comparable and that members maintain their performance. The EDQM designs and organises the Proficiency Testing Scheme following the principles of "ISO/IEC 17043 Conformity Assessment - General Requirements for proficiency testing". This supplements laboratories' internal quality control procedures by providing an external measure of their testing capability. The Proficiency Testing Scheme ( PTS) is a form of external assessment of quality control management systems using inter-laboratory comparisons to determine the performance of individual laboratories in carrying out specific tests or measurements. A European Scheme Open to the General European OMCLs Network and other Medicines Control Laboratories Background
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