Good laboratory practice harmonization

Note GLP = Good Laboratory Practice ICH = International Conference on Harmonization IND = Investigational New Drug JMHW = Japanese Ministry of Health and Welfare MAA = Marketing Authorization Application NCE = New Chemical Entity. 

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 reliability of measurements plays a pivotal role in food and agricultural areas, particularly in the case of undesirable toxic compounds such as mycotoxins. Quality-control principles for mycotoxin analysis are common to other trace analyses, so good laboratory practices, such as EN 4500, represent the heart of quality assurance requirements. Harmonized Guidelines for Internal Quality Control in Analytical Chemistry Laboratories, published by IUPAC (23), also presents valuable guidelines for the determination of mycotoxins. 

Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonization of laws, regulations, and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version). OJ L50/44, 20.02.2004, p44. 

While data from internationally harmonized test methods are preferred, in practice, data from national methods may also be used where they are considered as equivalent. In general, it has been agreed that freshwater and marine species toxicity data can be considered as equivalent data and are preferably to be derived using OECD Test Guidelines or equivalent according to the principles of Good Laboratory Practices (GLP). Where such data are not available classification should be based on the best available data. 

Good manufacturing practice (GMP), good clinical practice (GCP) and good laboratory practice (GLP) guidelines of the EU were issued uid the drug approval application format Wcis harmonized with the EU Notice for Applicants. 

The International Committee on Harmonization (ICH) Good Clinical Practice guidelines E6(R1), EDA Regulations relating to good clinical practice and clinical trials (CER 21), and EDA Good Laboratory Practice guidelines may be helpful references. New projects that use an established biorepository are submitted for determination of review status (e.g., exempt, expedited, full board review). 

Council Directive 87/18/CEE of 18 December 1986 On the Harmonization of Laws, Regulations and Administrative Provisions Relating to the Application of the Principles of Good Laboratory Practice and the Verification of their Applications for Tests on Chemical Substances. Official Journal L 15. 

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