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, helping to ensure the distribution of good quality medicines to the country’s citizens. The Rostov-on-Don facility is the first official medicines control laboratory in Russia to have achieved internationally recognized ISO accreditation.
The Rostov-on-Don laboratory was supported in this achievement by the U.S. Pharmacopeial (USP) Convention, a scientific nonprofit organization that develops standards for the identity, quality, purity, strength and consistency of medicines as well as dietary supplements and food ingredients. USP, through its Promoting the Quality of Medicines (PQM) program), provided technical assistance to Roszdravnadzor in a number of different capacities, including 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 U.S. headquarters to observe first hand how USP’s quality management system complies with ISO standards. This support occurred in several stages between September of 2011 and October of 2012.
“I congratulate the Rostov-on-Don laboratory and Roszdravnadzor on this tremendous achievement, which is the culmination of much diligence and hard work,” said Roger L. Williams, M.D., chief executive officer of USP.
“The importance of this accreditation should not be understated. Patients and doctors should be able to trust that the medicines they take or administer are of high quality. The work we all do in helping to ensure that is the case is vital and life-saving. There is no better way to demonstrate commitment to quality than to submit oneself to the objective scrutiny of public quality standards such as those offered by ISO.”
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. In addition to supporting the accreditation effort, USP also provided pharmacopeial education to Russian medicines quality control experts in Rostov-on-Don and in St. Petersburg. Dr. E.A. Telnova, Roszdravnadzor’s acting director, noted that this was well received and confirmed opportunities for USP-Roszdravnadzor cooperation, in the spirit of the Memorandum of Understanding the two organizations signed in 2009 and renewed in 2012.
Promoting the Quality of Medicines (PQM) (which is funded by the U.S. Agency for International Development ) serves as USAID’s primary mechanism to help ensure the quality, safety, and efficacy of medicines essential to USAID priority diseases, particularly malaria, HIV/AIDS, and tuberculosis.
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