Friday, August 10, 2012

Good Laboratory Practices (GLP)

GLP's are regulatory guidelines designed to prevent malpractices in research and development. The GLPs are designed to promote the quality and validity of the test data. GLP was imposed on the industry by regulatory authorities, in the same way as good manufacturing practice (GMP) had been before, and followed by good clinical practice (GCP) afterwards. FDA issued mandatory requirements for GLP on June 20, 1979 and they apply for all non-clinical studies used to evaluate safety. It is also instituted by all OECD(Organization for Economic Co-operation and Development) countries.

The fundamental requirements of the GLPs focusses on standardization of 5 categories:
1. Resources: organization, personnel, facilities and equipment.
2. Rules: protocols and written procedures.
3. Characterization: test items and test systems.
4. Documentation: raw data, final report and archives.
5. Quality assurance unit.

The main goal of the GLPs is to make results reliable, repeatable, auditable and recognized by scientists worldwide.

It aims at making False Negatives and False Positives markedly obvious to validate results better and to promote mutual recognition and comparison of study data universally.



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