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Good Laboratory Practice as the quality system ensuring mutual acceptance of test results in the registration of pharmaceutical products.

Tomasz G. Wasiela 

Biuro do Spraw Substancji i Preparatów Chemicznych, Dowborczyków 30/34, Łódź 90-019, Poland

Abstract

In 1981 Organisation for Economic Co-operation and Development (OECD) considering the need for and benefits of mutual acceptance in OECD countries of test data used in the assessment of chemicals and other uses relating to protection of man and the environment, have adopted Decision [C(81)30(Final)] on the strength of which 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.

Mutual acceptance of data (MAD) system has been adapted also by European Union Member States. One of the main areas where the requirement of compliance with Good Laboratory Practice exists is studies on pharmaceutical products. Pharmacokinetic and toxicological studies of those products submitted for registration purposes, if not performed in compliance with the GLP Principles, by right cannot be accepted by Regulatory Authorities. The GLP is that necessary quality standard which enable mutual recognition of test results performed by certified testing laboratories in  other EU and OECD countries.

 

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Presentation: Invited oral at VII Multidyscyplinarna Konferencja Nauki o Leku, by Tomasz G. Wasiela
See On-line Journal of VII Multidyscyplinarna Konferencja Nauki o Leku

Submitted: 2010-03-22 10:52
Revised:   2010-03-22 10:52