The importance of proficiency testing schemes for the performance improvement of medicines quality control laboratories

Abstract

In the last few decades proficiency testing schemes (PT schemes) have become especially important for the testing and calibration laboratories performance improvement, as well as one of the prerequisites for the successful accreditation of laboratories. This paper explains the particular significance of PT scheme for medicines quality control laboratories, which are participating only in the PT schemes organized by the European Directorate for the Quality of Medicines and Healthcare. Also, the paper describes the essential prerequisites for accreditation of the first national PT provider in the field of medicines quality control, as well as the quality assurance aspects of a PT scheme in this area. National Control Laboratory has the necessary resources and the required competence for the organization and implementation of the PT scheme, and may be accredited as a provider PT. It was pointed out that the participation of quality control laboratories belonging to the pharmaceutical industry in these studies represented a distinct improvement in the strengthening of trust between the pharmaceutical industry and the national regulatory body, because the results of PT schemes would be used for educational purposes only in order to improve and harmonize methods for analysis of drugs that are on the national market.

Keywords

• proficiency testing schemes
• regulatory body
• laboratory performance
• accreditation