Guidelines for GLP

Present-day analytical laboratories are increasingly under pressure to supply objective evidence of their technical competence, of the reliability of their results and performance, and to seek formal certification or accreditation. This pressure may come from the laboratory s customers (e.g., industry and national bodies) but may also be due to scientific considerations. A QM system in place, validation of methods, uncertainty evaluation, the use of primary standards and CRMs, participation in ILCs, and PT, all serve to assure and demonstrate the quality of measurements. Compared to, say, 30 years ago, the stability of the equipment now available is much improved, and a greater range of RMs for method validation and calibration is accessible. Nevertheless, to achieve mutual (international) acceptance of various bodies of evidence for QA activities, a number of protocols have been developed. The most widely recognized protocols used in chemical measurements and testing are the ISO Guide 9000 2000, ISO/IEC 17025 2005, and OECD Guidelines for GLP, as well as its national and sector equivalents. 

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... 

It should be noted that the Council s Decision does not commit members of the OECD to adopt these test guidelines and GLP s as enforceable requirements. Rather, the Council issued a Recommendation that "Member countries, in the testing of chemicals, apply" the guidelines and GLP s. Thus, while the Decision commits Members to accept, for purposes of their own assessments and evaluations, any data that are generated in accordance with these guidelines and principles, Members remain free to select these or any others for their own national use. 

The Government of India has established the National GLP Compliance Monitoring Authority (India GLP), adopting the OECD quality system of the principles of GLP, for inspection, monitoring, and accreditation of test facilities in India for conducting nonclinical and environmental safety studies. Currently, India enjoys the full member status of OECD for GLP. India is a member of the OECD Test Guidelines program. 

In addition to the development of the OECD Principles of GLP, the OECD Expert Group was given the responsibility of developing two additional guidance documents—one for the Implementation of OECD Principles of GLP and one as OECD Guidelines for National GLP Inspections and Study Audits. 

The OECD Guidelines for National GLP Inspections and Study Audits document serves as a companion document to the Principles and is intended to provide national authorities additional guidance in preparing and implementing their national GLP compliance programs. 

In addition, the American Association for Laboratory Animal Science (AALAS) provides guidelines for animal care and use, operates a certification program for animal technicians, and develops educational materials. The AALAS also serves as a scientific forum for laboratory medicine and care. The American Association for the Accreditation of Laboratory Animal Care (AAALAC) offers a peer review laboratory accreditation program for research facilities. In addition, the FDA and the EPA have Good Laboratory Practice (GLP) regulations. 

For ISO 9000 approval there are several certification bodies who register and certify companies meeting the requirements. In the UK such certification bodies must themselves be accredited by UKAS as competent to carry out certifications. For GLP. the GLP Monitoring Authority of the Medicines Control Agency issues a letter of compliance to an approved laboratory. This is restricted to laboratories carrying out safety studies as described above. However, any laboratory may state they work within the GLP guidelines. In the case of accreditation by UKAS, a Certificate of Accreditation is issued which relates to specific tests or calibrations. Laboratories will be included in UKAS s list of accredited laboratories, i.c. UKAS Directory of Accredited Labora-... 

All of the reagents and solutions used in the laboratory areas need to be labeled to indicate identity, titer or concentration, storage requirements, and expiration date. These must be discarded if the reagents or solutions are deteriorated or outdated. The GLPs have strict guidelines for the test and... 

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