Operational Status and Improvement of OECD Good Laboratory Practice (GLP)

Good Laboratory Practice (GLP) status of Asian countries and its implementation in non-clinical safety studies in pharmaceutical drug development.

Non-clinical animal studies to assess the safety of compounds under development have to comply with Good Laboratory Practice (GLP). The Organization for Economic Co-operation and Development (OECD) has established the Mutual Acceptance of Data (MAD) system in OECD member countries for the mutual acceptance of non-clinical safety study data. Since 1997 non-OECD-member countries have also been ab...

[OECD series on principles of good laboratory practice and compliance monitoring].

Critical aspects in the application of the principles of good laboratory practice (GLP).

The principles of good laboratory practice (GLP) are very flexible and an accurate interpretation is required in the application phase. Each test facility has to apply the principles of GLP within its own laboratories, taking into account both the cultural and the organisational aspects. Furthermore, the GLP quality system, as all quality systems, is a dynamic, not a static one. Continuous impr...

OECD and USA GLP applications.

Since the inception of the FDA good laboratory practice (GLP) regulations in 1979, the Organisation for Economic Co-operation and Development (OECD) principles of GLP in 1981 and the finalization of the EPA GLP programme in 1983 there have been recognizable differences among the three compliance programmes. All have been revised since their initial publication, but still there remain difference...

Technical note:Beyond Good Laboratory Practice