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Principles of GLP and Compliance Monitoring | 71986
International Research Journals

Principles of GLP & Compliance Monitoring

Abstract

Pradeep Deshmukh

The Principles of Good Laboratory Practice (GLP) are a managerial quality control system covering the organisational process and the conditions under which non-clinical health and environmental studies are planned, performed, monitored, recorded, reported and retained (or archived). The OECD Principles of GLP are followed by test facilities carrying out studies to be submitted to receiving authorities for the purposes of assessing the health and environmental safety of chemicals and chemical products which may also be of natural or biological origin and, in some circumstances, may be living organisms.

The Principles of GLP define the responsibilities of test facility management, study director, study personnel and quality assurance personnel that are operating within a GLP system, and minimum standards concerning the suitability of facilities and equipment to perform studies, the need for standard operating procedures, documentation of raw data, study reports, the archiving of records, etc.

The main intent of GLP is to regulate the practice of Scientists working on safety testing of prospective drugs. The safety of a drug is the key issue and GLP is seen as a means of ensuring that scientists do not invent or manipulate safety data and ensuring that studies are properly managed and conducted to obtain valid experimental data. The GLP regulations are set of rules for good practice and help researchers to perform their work in compliance with OECD-GLP principles using approved study plan and standard operating procedures

 

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