Good laboratory practice provisions

GLP has several provisions, and all are interlinked. The purpose of these provisions is to help generate data of quality and integrity. These may be listed in brief  

It is important to understand the GLP provision in toto. However, present discussions are largely about the worker, who should know how to conduct studies in a laboratory/workplace to comply with GLP. Generation of quality data gives credibility to the results and report, to the laboratory or industry, and to the organization as a whole. Keeping this in view, emphasis has been given to the selected parts of GLP, which are as follows  

Facilities personnel, laboratory, animal, materials, and equipment 

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Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation 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... 

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. 

Part 160 - GOOD LABORATORY PRACTICE STANDARDS Subpart A - General Provisions... 

Additionally, every vendor qualification program should include provisions for quality planning. This allows the sponsor to plan for audit events across project schedules. Vendor qualification for any project can be divided into two sections, each with three tracks. Each section will contain atrack for regulated work products. Good laboratory practice, GCP, and GMP define regulated work products. 

EU law expressly requires nonclinical (pharmacotoxicological) studies to be carried out in conformity with the provisions related to good laboratory practice set out in Directive 2004/10/EC [33] and Directive 2004/9/EC [34] on the inspection and verification of laboratory practice. 

To generate quality data of a chemical substance and to comply with good laboratory practice, many provisions are set by the OECD." " - In brief, these include the following ... 

While it is the Study Director who is ultimately responsible for the quality of the study as a whole, he/she cannot be held responsible for the quality of each and every data point and each and every single record. This is clearly the domain of responsibility of the study personnel, who are are responsible for recording raw data promptly and accurately and in compliance with these Principles of Good Laboratory Practice, and are responsible for the equality of their data . Certainly, these raw data will be scrutinised by the Study Director, who will use them for the preparation of the final study report certainly these raw data will be checked by Quality Assurance for their compliance with the provisions of the GLP Principles. However, data quality cannot be obtained retrospectively by control measures ( quality cannot be controlled into the data ), data have to be recorded in such a way that quality is an intrinsic characteristic of these records. Thus, this responsibility of study personnel for the quality of their data cannot be emphasised strongly enough. 

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. 

The EPA adopted ERPs for each of the major TSCA provisions. There is an ERP that apphes to violations of 4 test rules as well as one that applies to the Good Laboratory Practice rules estabhshed under one for 8, 12 and 13 adverse effect reporting and imports and exports," one for 5 including the premanufacture notification rules," one for PCBs," two for lead," and one for asbestos. ... 

All studies must be conducted according to the methods described in Annex V to Directive 67/548/EEC [3] under the provisions of Council Directive 87/18/EEC [4] relating to the application of the principles of good laboratory practice. Deviations from these requirements must be justified and will be decided on a case-by-case basis. 

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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