M.A. Zaytseva, M.B. Ivanov, L.V. Pikalova, A.S. Melehova

Harmonization of Russian and European regulatory requirements GLP OECD at preclinical studies lead to quality increasing of test facility. The one of the main point of GLP compliance at the test facility is Quality management system implementation. The test facility should have a documented Quality Assurance Programme to assure that studies performed are in compliance with these Principles of Good Laboratory Practice. The Quality Assurance Programme should be carried out by an individual or by individuals designated by and directly responsible to management and who are familiar with the test procedures. This individual(s) should not be involved in the conduct of the study being assured. QA personnel should have the training, expertise and experience necessary to fulfil their responsibilities. They must be familiar with the test procedures, standards and systems operated at or on behalf of the test facility. Individuals appointed to QA functions should have the ability to understand the basic concepts underlying the activities being monitored. They should also have a thorough understanding of the Principles of GLP. Delegation to QA of tasks which are attributed to management in the GLP Principles must not compromise the independence of the QA operation, and must not entail any involvement of QA personnel in the conduct of the study other than in a monitoring role. The person appointed to be responsible for QA must have direct access to the different levels of management, particularly to top level management of the test facility. Management is responsible for ensuring that Standard Operating Procedures are produced, issued, distributed and retained. QA personnel are not normally involved in drafting SOPs; however it is desirable that they review SOPs before use in order to assess their clarity and compliance with GLP Principles. The responsibilities of the Quality Assurance personnel include maintain copies of all approved study plans and Standard Operating Procedures; verify that the study plan contains the information required for compliance with these Principles of Good Laboratory Practice; conduct inspections to determine if all studies are conducted in compliance with these Principles of Good Laboratory Practice; promptly report any inspection results in writing to management and to the Study Director, and to the Principal Investigator(s) and the respective management, when applicable; prepare and sign a statement, to be included with the final report, which specifies types of inspections and their dates, including the phases of the study inspected, and the dates inspection results were reported to management and the Study Director and Principal Investigators, if applicable. This statement would also serve to confirm that the final report reflects the raw data. Quality Assurance personnel should plan its work properly and its planning procedures as well as the operation of Quality Assurance personnel in performing, documenting and reporting inspections should be described in SOPs. Quality Assurance personnel is responsible for checking of corrective actions, which realized during inspections.