Head of the Federal Service for Surveillance in Healthcare Mikhail Murashko made an on-site visit to the Krasnoyarsk branch of Roszdravnadzor’s Information-Expertise Centre for Expert Examination, Monitoring and Analysis of Medicinal Products.
The Krasnoyarsk Branch’s testing laboratory is nationally accredited for compliance with requirements of GOST ISO/MEK 17025-2009, has a certificate of conformity to the OECD Principles of Good Laboratory Practice, and has ANAB international accreditation and EDQM certification. In April 2016, the testing laboratory was also audited as part of the World Health Organization’s evaluation of the vaccine circulation regulation system currently effective in the Russian Federation.
During his visit, Roszdravnadzor’s Head could familiarize himself with how all units of the laboratory complex operate: analytical, pharmacological and microbiological laboratories, the laboratory for medical immunobiological preparations, the organizational unit and the Quality Service.
Mikhail Murashko visited the animal quarters and the facilities for biological control tests (for pyrogenicity, abnormal toxicity, measurement of the drug bioactivity, microbial limits, sterility, measurement of antimicrobial activity of antibiotics by agar diffusion methods, bacterial endotoxins, etc.). Mikhail Murashko also took a close look at the instrumentation pool and studied the usability of the entire laboratory equipment for testing vaccines, serums, immunoglobulins, and blood-derived products for their applicability to biomedical product testing.
In the organizational unit of the laboratory facilities Mikhail Murashko was demonstrated a software product that allows tracing a drug specimen by its identification number from the moment it arrives for a test until it is archived. In the testing laboratory Roszdravnadzor’s Head could study the quality management system.
After the visit, Mikhail Murashko noted the high level at which work is organized at the Krasnoyarsk Branch of Roszdravnadzor’s Information-Expertise Centre for Expert Examination, Monitoring and Analysis of Medicinal Products and underlined that international accredited laboratories are highly important in pre-clinical studies of medicinal products on a country-wide scale.