Good laboratory practice guidelines

When the first draft of a protocol is typed, it is sent to the Quality Assurance Section to be audited. The protocol is checked for those details required by the Good Laboratory Practices guidelines. Comments about each protocol are sent to the study director. When the final version of the protocol is typed, it is again sent to Quality Assurance for review. The original copy of the signed and dated protocol is filed in the archive. 

The Good Laboratory Practice Guidelines (GLP) have been in existence for non-clinical safety studies since They have progressed through various transitional phases to become guidelines in some countries and regulatory/statutory instruments in others. 

In addition, all nonclinical toxicology studies that are intended to support clinical trials or marketing applications must be conducted in compliance with Good Laboratory Practices guidelines... 

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). 

Guidelines for Registering Pesticides in the United States Proposed Good Laboratory Practice Guidelines for Toxicology Testing, U5 Fed. Reg. 26373 (April 8, I980). 

Irrespective of the final selection of data acquisition parameters, full documentation of the experimental details should be recorded with all spectra, especially if regulated procedures are followed. Also, as a general rule, it is recommended that good laboratory practice guidelines are adopted throughout. 

As vith human pharmaceuticals, all safety studies must be conducted in accordance vdth the principles of Good Laboratory Practice (GLP). Similar to the International Conference on Harmonisation (ICH), the Veterinary International Conference on Harmonisation (VICH) has developed agreed guidelines on the types of test and other considerations that need to be addressed during the development and evaluation of veterinary medicines. A list ofVICH guideline topics is provided in Table 7.1. 

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... 

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). 

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). 

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. 

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