Good laboratory practice test facility

Test facilities in the OECD (Organization for Economic Co-operation and Development) member countries that conduct regulatory studies must comply with the OECD Principles of Good Laboratory Practice (GLP), as set out in Council Decision C(97)186/Final. These are referred to as GLP Principles. GLP came into prominence in the late 1970s in response to some malpractice in research and development activities of pharmaceutical companies and contract... 

The Aimex I of the Directive 2004/9/EC consists of two parts Part A (Guides for compliance monitoring procedures for good laboratory practice) and Part B (Guidance for the conduct of test facility inspections and study audits). The provisions for the inspection and verification of GLP which are contained in Parts A and B are those contained in Annexes I and II respectively of the OECD Council Decision-Recommendation on comphance with principles of good laboratoiy practice. 

Good Laboratory Practice is a qnahty system concerned with the organisation of the test facility and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. This is the GLP Decalogue stating the basic principles that the laboratory must follow. 

Management has both directive and supportive responsibilities for the operations of the quality assurance unit to fully achieve compliance with Good Laboratory Practice regulations (1,2). The tone for the entire testing facility is set by management since it is their ultimate responsibility to establish and endorse procedures and policies which ensure a commitment to quality. 

The Manager of a testing laboratory is responsible for ensuring that the Principles of Good Laboratory Practice are complied with in the facility. The OECD has set down the minimum responsibilities, which should be to... 

Ensure that a statement exists which identifies the individual(s) within a test facility who fulfil the responsibilities of management as defined by these Principles of Good Laboratory Practice. 

In summary, four pillars support the structure of Good Laboratory Practice. All of them serve important functions in the context of performing and monitoring safety studies, and all of them need to be based on the strong conviction that GLP is the one mean to achieve quality data. Certainly, there are other aspects and issues in GLP that may be seen as nearly equally important, and they will be dealt with extensively further on, but Test Facility Management, Quality Assurance, Study Director, and National Compliance Monitoring Authorities are the key positions where real adherence to the Principles of GLP, not only by the letter but by the spirit of them, is determined in the end. 

Test facility management means the person(s) who has the authority and formal responsibility for the organization and functioning of the test facility according to these Principles of Good Laboratory Practice. 

Quality Assurance Programme means a defined system, including personnel, which is independent of study conduct and is designed to assure test facility management of compliance with these Principles of Good Laboratory Practice. 

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