Russian Lab Achieves ISO Accreditation

Mar 05, 2013

The Rostov-on-Don Medicines Quality Control Laboratory of the Federal Service on Surveillance in Healthcare (Roszdravnadzor) has attained ISO/IEC 17025:2005 accreditation for testing and calibration laboratories. The facility is the first official medicines control laboratory in Russia to have achieved internationally recognized ISO accreditation, according to a press release from the U.S. Pharmacopeial (USP) Convention.

The accreditation was awarded by ACLASS, an accrediting body based in Washington, D.C., for seven key analytical tests: high-performance liquid chromatography, dissolution, ultra-violet visible spectroscopy, thin-layer chromatography, Karl Fischer titration, pH, and limulus amebocyte lysate.

The accreditation certifies that the Rostov-on-Don laboratory is providing valid and trustworthy data to Roszdravnadzor, the Russian drug-monitoring agency, helping to ensure the distribution of good quality medicines. The USP, provided technical assistance to Roszdravnadzor through its Promoting the Quality of Medicines (PQM) program. Assistance included conducting an assessment of the Rostov-on-Don laboratory’s quality management system against ISO/IEC standards; providing ongoing monitoring of the laboratory’s progress toward accreditation; and hosting Roszdravnadzor staff at its US headquarters to observe how USP’s quality management system complies with ISO standards. This support occurred in several stages between September 2011 and October 2012.

ISO/IEC 17025:2005 accreditation positions Rostov-on-Don as an international reference for labs working on quality control of pharmaceutical products. It extends the lab’s reach in supporting public health across Russia and the wider region.