Good laboratory practice study purpose

In 1981, the OECD Principles of GLP were finalized and led to the OECD Council Decision on the Mutual Acceptance of Data (MAD) which states that Data 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 . The OECD recommended in 1983 that implementation of GLP compliance should be verified by laboratory inspections and study audits. The EC later ratified the OECD principles and a number of Directives (e.g., 2004/9/EC, 2004/10/EC) indicates that tests must be carried out in compliance with the principles of GLP and that also that EU Member States must incorporate into their laws the requirement for all nonclinical safety studies to be conducted in compliance with GLP, and that premises conducting such studies must be inspected by a national authority. 

For the purpose of following the Principles of Good Laboratory Practice it must be recognised that the term phase of a study may be applied to two different levels of study conduct. It may be connected with the gross divisions of a study which follow the time course of study development, but it may also be used to denote single activities within the experimental conduct of a study. They are furthermore directed towards two different areas of study conduct and study control. 

Unless specifically exempted by national legislation, these Principles of Good Laboratory Practice apply to all non-clinical health and environmental safety studies required by regulations for the purpose of registering or licensing pharmaceuticals, pesticides, food and feed additives, cosmetic products, veterinary drug products and similar products, and for the regulation of industrial chemicals. 

In the Phase I studies it was shown that in cell cultures [NaCa(P03)3] fibers degraded and cleared as predicted. Rather than attempting to give a detailed analysis of the work here the reader is referred to the original article. There, the minute compliances with the Good Laboratory Practice Regulations dictated by the EPA are related. It will suffice for our purposes to quote the summary statement from the article. 

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