Good Laboratory Practice part

Laboratory practice should follow Australian Standard 2830.1 Good laboratory Practice, Part 1, Chemical Analysis and the requirements of Section 5 of this Code-Documentation. Particular emphasis should be given to the provision of a comprehensive system of calibration and to the systematic filing of superseded methods and the dating of revisions. Guidelines for the calibration of certain instruments are given in Appendix D. 

European Commission, Guideline Developed with the Standing Committee on Plant Health with Regard to the AppUcabdity of Good Laboratory Practice to Data Requirements According to Annexes II, Part A and III, Part A of Council Directive 91/414/EEC, 7109/VI/94 Rev. 6, 14.07.1995. European Commission, Bmssels (1995). 

US EPA, HERA, Good Laboratory Practice Standards, Final Rule (40 CFR Part 160 [OPP-300165A FRL-3518-2]) RIN 2070-AB68, Environmental Protection Agency, Washington, DC... 

CFR, Part 160, Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Good Laboratory Practice Standards Final Rule, August 17, 1989, United States Environmental Protection Agency, Washington, DC (1989). 

Final Rule for Good Laboratory Practice Standards under the Federal Insecticide, Fungicide and Rodenticide Act, Code of Federal Regulations, Title 40, Part 160. 

To date, the Part II Programme has focused upon four major projects (1) The development and implementation of a set of Principles of Good Laboratory Practice (GLP s) (2) Resolution of issues concerning Confidentiality of Data (3) Development of a Glossary of Key Terms and (4) Development of guidelines and other procedures for the exchange of information (e.g., re test data, the export of hazardous chemicals, and the labelling of hazardous chemicals). 

FDA (Food and Drug Administration). (1987a). Good Laboratory Practice Regulations Final Rule. 21 CFR Part 58, Federal Register, September 4, 1987. 

Exhibit 5.1 FDA 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies Table of Contents... 

CFR Part 58 Good Laboratory Practices for Non-clinical Laboratory Stndies... 

Validation itself is considered a required part of good laboratory practice (GLP) and good manufacturing practice (GMP) within any pharmaceutical laboratory and has been defined by the FDA as ... 

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. 

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. 

The importance of undertaking a careful detailed autopsy on each animal cannot be overemphasised. Organs should be sectioned in a standard manner. The pathologist should adopt a consistent nomenclature and a peer review of the slides has become an accepted part of Good Laboratory Practice. 

Part 160 - GOOD LABORATORY PRACTICES FOR NONCLINICAL LABORATORY STUDIES STANDARDS... 

Good Laboratory Practice Regulations, Part 160 (40CFR), Environmental Protection Agency, Washington, D.C. 

Department of Health, Education and Welfare, Food and Drug Administration. 21 CFR Part 58 Good laboratory practice regulations Proposed rule. Fed Reg 49 43529-43537, 1984. 

CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies. 

In a modem laboratory the general guidehnes encompassed in good laboratory practices require careful interpretation when apphed to a laboratory that relies heavily on automated documentation, data files, and electronic signatures 21 CFR part 11 provides that interpretation. 

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