Evaluation of Laboratory Quality Management Systems: Rostov-on-Don and Kazan Roszdravnadzor Regional Medicine Quality Control Laboratories

Agency for International Development (USAID), is a technical assistance program aimed at improving the quality of medicines in developing countries. PQM works with local authorities to build capacity in medicine quality assurance systems, increase the supply of quality medicines, and ensure the quality and safety of medicines globally. In 2010, PQM received funding from USAID/Russia to assist Roszdravnadzor in improving their Regional Medicine Quality Control (QC) Laboratories' compliance with international quality management system (QMS) standards. Roszdravnadzor's goal is to have all of their Regional Medicine QC Laboratories obtain ISO/IEC 17025:2005 accreditation and subsequently be incorporated into the list of World Health Organization (WHO) Prequalified (PQ) medicine QC laboratories. The PQM team conducted a trip to Russia to evaluate the QMS of Roszdravnadzor Regional Medicine Quality Control Laboratories in Rostov-on-Don and Kazan. The evaluation was performed using the WHO Good Practices for National Pharmaceutical Control Laboratories (GPPQCL) and the International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2005 Standards. The Rostov-on-Don Roszdravnadzor Regional Medicine QC Laboratory was evaluated to assess the implementation and effectiveness of Corrective and Preventive Actions (CAPAs) for nonconformities previously identified. The evaluation included inspecting the facilities and interviewing the staff. The goal for the Rostov-on-Don laboratory is to obtain ISO/IEC 17025:2005 accreditation and be incorporated into the list of WHO Prequalified medicine QC laboratories. The Kazan Roszdravnadzor Regional Medicine QC Laboratory was also evaluated to assess its QMS. The evaluation aimed to identify areas for improvement and provide recommendations for strengthening the laboratory's QMS. The goal for the Kazan laboratory is to obtain ISO/IEC 17025:2005 accreditation and be incorporated into the list of WHO Prequalified medicine QC laboratories. The PQM team worked with the laboratories to implement effective corrective actions and provided technical assistance to strengthen their QMS. PQM will continue to work with the laboratories to ensure that they meet the required standards for ISO/IEC 17025:2005 accreditation and WHO Prequalification. The evaluation of the Rostov-on-Don and Kazan laboratories was conducted using internationally recognized standards, including the WHO Good Practices for National Pharmaceutical Control Laboratories (GPPQCL) and the International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2005 Standards. The evaluation aimed to assess the laboratories' compliance with these standards and provide recommendations for improvement. The PQM program has been working with Roszdravnadzor to improve the quality of their Regional Medicine QC Laboratories. The program has provided technical assistance to the laboratories to strengthen their QMS and improve their compliance with international standards. The goal of the program is to ensure that the laboratories meet the required standards for ISO/IEC 17025:2005 accreditation and WHO Prequalification. The evaluation of the Rostov-on-Don and Kazan laboratories was a critical step in the process of improving the quality of their Regional Medicine QC Laboratories. The evaluation provided a comprehensive assessment of the laboratories' QMS and identified areas for improvement. The recommendations provided by the evaluation will help the laboratories to strengthen their QMS and improve their compliance with international standards.