On January 22-24, Marta Bushe and Jemile Mamleeva — Russian GLP inspectors and representatives of the National Institute’s for Accreditation of RusAccreditation Coordination Center for implementation of the OECD GLP principles and ensuring the reliability and consistency of test results — took part as observers in a GLP inspection in Harrogate (Great Britain) performed by inspectors from Medicines & Healthcare products Regulatory Agency (MHRA) — a monitoring body and the GLP regulator of Great Britain. The event was held within the Russia–OECD project “Technical Support of Improvement of Good Laboratory Practice (GLP) in Russia” and was aimed at increasing the competence of Russian inspectors.
The three-day event covered practical aspects of GLP inspections such as test data integrity and quality audit when used in computer systems and electronic workflow by a testing center, identification of inconsistencies and their ranking according to their impact on test results, and generation of inspection reports. The inspection also considered issues of keeping non-human primates, miniature pigs and beagle dogs used as biological GLP testing systems and characteristics of administering test substances to those kinds of laboratory animals.
On January 25, the event was followed by a meeting of the Russian inspectors with the MHRA Head of Inspectorate and Process Licensing Department Andrew Gray who explained approaches and procedures the monitoring body of Great Britain uses for organization and carrying out inspections of testing centers, particularly about the use of the risk-oriented approach for defining inspection frequency, categorization of testing centers according to the volume of ongoing tests, and collection of data on discrepancies revealed in testing centers’ performance. Andrew Gray noted that the majority of testing centers in Great Britain are switching to electronic workflow and the monitoring body together with software producers provides training for inspectors in order to improve their qualification in the inspection of computer systems.
The meeting covered legislative features of the Russian national GLP system, as well as similarities and differences between the GLP programs in Russia and Great Britain. Participants of the meeting emphasized the importance of such an exchange of information and opinions since the Russian GLP system would be audited for its compliance with the OECD requirements in 2019.
The plans for 2019 include the participation of Russian GLP inspectors in similar assessments in other foreign countries and audit of the national GLP system for its compliance with the OECD requirements. The latter entails an analysis of documents and procedures and an on-site inspection of RusAccreditation as the national monitoring body.
Marta Bushe is the Head of the National Institute’s for Accreditation of RusAccreditation Coordination Center for implementation of the OECD GLP principles and ensuring the reliability and consistency of test results.
Jemile Mamleeva is the Chief Specialist of the National Institute’s for Accreditation of RusAccreditation Coordination Center for implementation of the OECD GLP principles and ensuring the reliability and consistency of test results.