Download Good Laboratory Practice — the Why and the How by Jürg P. Seiler PDF

By Jürg P. Seiler

After greater than two decades of use sturdy Laboratory perform, or GLP, has attained a safe position on this planet of trying out chemical substances and different “test goods” with reference to their protection for people and the surroundings. long gone are the times whilst the GLP laws have been hotly debated among scientists in academia and and have been accused of stifling flexibility in, inventive methods to, and science-based behavior of, every kind of reviews interested in poisonous results and different parameters vital for the overview and review of goods submitted for registration and permission to industry. The GLP laws have constructed from principles on the best way to precisely rfile the making plans, behavior and reporting of toxicity reports to a high quality approach for the administration of a large number of analysis forms, from the easy choice of a physical/chemical parameter to the main advanced box experiences or ecotoxicology reports. while the time period “Good Laboratory perform” has turn into a bit of of a slogan with the purpose to characterise any reliably performed laboratory work.

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Additional resources for Good Laboratory Practice — the Why and the How

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6. Where Can GLP be Profitably Applied ? As has been described above, GLP is a quality system which has found mandatory application in the safety testing of any items where the results of such testing will be assessed by some national Regulatory Authority for the purpose of registering or licensing this item. In these cases it is to be applied and followed to the full extent of its “letter and spirit”. This does not mean that it is to be used exclusively within these defined and restricted boundaries.

With regard to the second requirement for the applicability of GLP, the submission of the data generated to a Regulatory Authority, an analogous dissection can be done from two angles: On the one hand according to the type of study, and on the other hand according to the nature and utilisation of the item to be studied. In relation to this second point, the scope of the OECD GLP Principles mentions pharmaceutical products, pesticide products, cosmetic products, veterinary drugs, food and feed additives, and industrial chemicals as examples of items possibly subject to testing under GLP.

This point has also been emphasised in an EPA Advisory, where it is stated that “Thus, at any time 32 Part I: What is GLP All About ? where it is known that study data are intended to be submitted to EPA under the scope and definition given in the regulation, that study must be performed according to GLP. , that study should also be conducted according to GLP. ” This interpretation has to be considered when judging the exemption from GLP formulated in the “study” definition of the EPA regulation.

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