GLP AND ITS SCOPE INTODUCTION: In experimental area of non-clinical research the phrase GLP(Good laboratory practices) refers to a quality system of management intended to support research or marketing permits for products, which are regulated by government agencies.GLP try to ensure uniformity, consistency, reliability, reproductively, quality, and integrity of chemical non-clinical safety tests from physio-chemical properties through acute to chronic toxicity tests. The term GLP is commonly associated with pharmaceutical industry and non-clinical animal testing that should be performed before the approval of new drug. However, GLP applies to many non-pharma companies
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Using GLP to perform bioanalysis for human clinical trials. As noted in the scope for both GLP and OECD GLP, the principles of GLP only apply to non-clinical studies. Therefore, following GLP, particularly with respect to QA reviews is an unnecessary cost. It is more important to follow analytical validation plans.
2. Performing GLP as a single person. GLP work requires at minimum 2 or 3 individuals. These are the person performing the work (analyst), a person reviewing the work (management), and a quality assurance reviewer (QA). If SOPs are written well, the analyst and the management can be the same individual; however, QA must always be an independent person.
3. Resulting of GLP studies are "right". A statement that a study was conducted in conformance with GLP simply means that quality system were followed, and that the result of the study accurately report the conduct of study. It does not indicate that the conclusions drawn are accurate, scientifically robust, or even useful.
GLP IN …show more content…
Industries/test/facilities/laboratories dealing with above chemicals and looking for approval from regulatory authority for obtaining GLP Certificate.
SCOPES: The Principles of Good Laboratory Practice should be applied to the non-clinical safety testing of test items contained in pharmaceutical products, pesticide, product, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals. These test items are frequently synthetic chemicals, but may be of natural or biological origin and, in some circumstances, may be living organism. The purpose of testing these test items is to obtain data on their properties and/or their safety with respect to human and/or the environment. Non-clinical health and environmental safety studies covered by Principles of Good Laboratory Practice include work conducted in the laboratory, in greenhouses, and in the field. Unless specifically exempted by national legislation, these Principle of Good Laboratory Practice apply to all non-clinical health and environmental safety studies as required by regulations for the purpose of registering or licensing
Using GLP to perform bioanalysis for human clinical trials. As noted in the scope for both GLP and OECD GLP, the principles of GLP only apply to non-clinical studies. Therefore, following GLP, particularly with respect to QA reviews is an unnecessary cost. It is more important to follow analytical validation plans.
2. Performing GLP as a single person. GLP work requires at minimum 2 or 3 individuals. These are the person performing the work (analyst), a person reviewing the work (management), and a quality assurance reviewer (QA). If SOPs are written well, the analyst and the management can be the same individual; however, QA must always be an independent person.
3. Resulting of GLP studies are "right". A statement that a study was conducted in conformance with GLP simply means that quality system were followed, and that the result of the study accurately report the conduct of study. It does not indicate that the conclusions drawn are accurate, scientifically robust, or even useful.
GLP IN …show more content…
Industries/test/facilities/laboratories dealing with above chemicals and looking for approval from regulatory authority for obtaining GLP Certificate.
SCOPES: The Principles of Good Laboratory Practice should be applied to the non-clinical safety testing of test items contained in pharmaceutical products, pesticide, product, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals. These test items are frequently synthetic chemicals, but may be of natural or biological origin and, in some circumstances, may be living organism. The purpose of testing these test items is to obtain data on their properties and/or their safety with respect to human and/or the environment. Non-clinical health and environmental safety studies covered by Principles of Good Laboratory Practice include work conducted in the laboratory, in greenhouses, and in the field. Unless specifically exempted by national legislation, these Principle of Good Laboratory Practice apply to all non-clinical health and environmental safety studies as required by regulations for the purpose of registering or licensing