“On 11 – 14 February 2020, a periodic inspection for the purpose of prequalification by the World Health Organization took place at the Pharmaceutical Analysis Laboratory of the State Expert Center of the Ministry of Health.
During the inspection, WHO specialists audited the activities of the Pharmaceutical Analysis Laboratory for compliance with the requirements of the World Health Organization in accordance with the following documents: “WHO Good Practices for Pharmaceutical Quality Control Laboratories” (WHO TRS, No. 957, 2010 – Annex 1), “Good Manufacturing Practice”, EDQM guidelines, ISO/IEC 17025:2017 “General requirements for the competence of testing and calibration laboratories”.
The audit program covered the procedure for laboratory testing of medicinal product samples by chemical, physicochemical, and biological methods of analysis; the functioning and effectiveness of the quality assurance system, including the analysis of the Laboratory's activities by top management; the availability and adequacy of resources such as personnel, premises, equipment, reagents, reference standards, etc., and of material and technical support; and the reliability of test results.
The official public WHO report will be published after the Center receives it.”
