OECD Good Laboratory Practice

The GLP principles are a managerial concept defining the organizational processes and conditions under which laboratory and field research is planned, performed, monitored, recorded, and reported. They were designed to ensure that sampling and analytical procedures and results are complete and of known, documented quality. When a study is GLP compliant, an auditor, regulator, or analyst should be able to review the smdy some years after its completion and easily determine what work was done, when, where, by whom, and with what equipment and methods who supervised the study what results were obtained and whether there were any problems encountered and, if so, how they were handled. Considerable effort and dedication in planning, support, and implementation is required to achieve this standard of documentation and attention to detail. Successful implementation of GLP provides reliable data for which the precision, accuracy, comparability, and completeness is known. 

Laboratories should follow GLP principles when carrying out non-clinical health and environmental safety studies for hazard assessment, including studies on antibiotics and other veterinary pharmaceuticals, and food and feed additives. The GLP principles, while sharing many common principles with ISO/IEC 17025, are less applicable than the ISO standard to laboratories performing routine or regulatory testing. 

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Immature female Wistar rats (15 days old) were housed individually in wire mesh cages with solid floors. Artificial light was maintained as a 12/12 h light/dark cycle under standard humidity and temperature conditions. Animals were weaned on conventional standardised laboratory diets. Diet and water were available ad libitum. All animals were acclimatised for 24 h before their injection. The study was conducted in accordance with the OECD Good Laboratory Practice Procedures [21]. 

US FDA. Comparison Chart of FDA, Environmental Protection Agency (EPA) and Organization for Economic Co-Operation and Development (OECD) Good Laboratory Practices, June 2004. http //www.fda.gov/ora/compliance ref/bimo/ comp aris on chart/... 

Organization for Economic Co-operation and Deveiopment (OECD) Good Laboratory Practice (GLP)... 

The characterisation of the toxicity associated with a specific chemical is invariably dependent on feeding the chemical to laboratory animals in statistically-based lifetime bioassay, guidelines for which have been agreed at the international level by the OECD (OECD, 1981) and the IPCS (IPCS, 1999), and which are undertaken strictly in compliance with the principles of good laboratory practice (GLP). The animals used in long-term bioassays are... 

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... 

Note that good laboratory practice (glp) should not be confused with Good Laboratory Practice (GLP). The latter is the name given to a set of principles governing the organizational process and the condition under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported, and was put forward initially by the Organization for Economic Co-operation and Development (OECD) (see Chapters 2 and 9). 

Principal organic hazardous constituents (POHCs), 13 184 Principal Register, 25 258-259 registration of a mark on, 25 263 Principles of Good Laboratory Practice (OECD), 18 540... 

D]ata generated in the testing of chemicals in an OECD Member country in accordance with OECD Test Guidelines and OECD Principles of Good Laboratory Practice shall be accepted in other Member countries for purposes of assessment and other uses relating to the protection of man and the environment. 

Member States shall take all measures necessary to ensure that the laboratories referred to in Article 7 of Directive 89/397/EEC1 comply with the general criteria for the operation of testing laboratories laid down in European standard EN 450013 supplemented by Standard Operating Procedures and the random audit of their compliance by quality assurance personnel, in accordance with the OECD principles Nos. 2 and 7 of good laboratory practice as set out in Section II of Annex 2 of the Decision of the Council of the OECD of 12 Mar 1981 concerning the mutual acceptance of data in the assessment of chemicals.4... 

As a tool to make mutual acceptance of risk assessments possible, OECD has developed the concept of Good Laboratory Practice (GLP). The OECD Principles of GLP are an integral part of the 1981 OECD council decision on the Mutual Assessment of Data (MAD) in the Assessment of Chemicals (revised 1997, Section 2.2.2). MAD also harmonizes procedures of GLP compliance monitoring, ensuring that preclinical safety studies are carried out according to the principles of GLP and that countries can have conftdence in the quahty and rigor of safety tests. 

The 1989 OECD council decision Recommendation on Comphance with Good Laboratory Practice requires the establishment of national comphance monitoring program based on laboratory inspections and study audits and recommends the use of the guides for comphance monitoring procedures for good laboratory practice and the guidance for the conduct of laboratory inspections and study audits. 

Compliance with the GLP principles covers many aspects of accreditation to ISO 17025. The European Union has adopted the procedures for Good Laboratory Practice of the Organization for the Economic Cooperation and Development (OECD) and calls on member states to take all measures necessary to ensure that laboratories carrying out tests on chemical products comply with the GLP principles. The OECD s GLP principles are part of the Eiuopean Commission Directive 2004/10/EC (http //eur-lex. europa.eu). 

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. 

OECD Member States developed the OECD principles of GLP, utilising common managerial and scientific practices and experience from varions national and international sources. The purpose of these principles of good laboratory practice is to promote the development of quality test data. 

Good Laboratory Practice is a quality system that is tailored to the needs of the modem laboratories. Its principles are very close to the principles of the modem quality management systems like ISO 9000 and ISO 17025. However, GLP is specific to the non-clinical health and environmental safety studies, it covers physical and chemical test systems, and gives emphasis to biological test systems. It is of utmost importance to note that GLP principles were set out by the Organization for Economic Cooperation and Development (OECD) and after being modified they were adopted by the Emopean Union and are now the Commission Directive 1999/11/EC. 

The recent amendment in November 2008 to the drugs and cosmetic rules (II) includes a new Schedule L-1, which covers the Good Laboratory Practices and Requirements of Premises and Equipments, primarily for laboratories that support manufacture. Despite such specific emphasis of its applicability, the details of GLP requirements are in general alignment with those of the OECD, USFDA, USEPA, etc. 

Good Laboratory Practice in the Testing of Chemicals, Organization of Economic Co-operation and Development (OECD), Paris, 1982. 

OECD, Environment Directorate—Chemicals Group and Management Committee (1998), OECD series on principles of good laboratory practice and compliance monitoring, number 1 OECD Principles on Good Laboratory Practice (Paris Organisation for Economic Co-operation and Development). 

An important requirement for toxicity tests is their reproducibility and repeatability. In conformation with the principles of good laboratory practice (GLP),27 it is recommended that they be performed according to standard procedures and guidelines prepared by world standardization organizations such as the OECD, ISO, or CEN. Table 9.1 presents a list of selected ISO standards and OECD guidelines with regard to the modality of toxicity tests. 

OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring. Number 1 OECD Principles on Good Laboratory Practice (as revised in 1997). Chemicals Group and Management Committee. ENV/MC/CHEM(98)17. 

When measured physicochemical data are available for registering chemicals or developing QS ARs, these data should be as high quality as possible, preferably performed to Good Laboratory Practice (GLP) standards and using the appropriate OECD Guideline. 

The OECD has produced an internationally accepted set of Principles of Good Laboratory Practice in order to promote the development of quality test data. These have been ratified by the European Commission and transposed into EC Directives. 

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... 

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