Laboratory Testing Blog

What is Good Laboratory Practice (GLP)?

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Good Laboratory Practice is defined in the OECD Guidelines as “a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.”  The purpose of Good Laboratory Practices is to promote the development of quality test data and provide a tool to ensure a sound approach to the management of laboratory studies, including conduct, reporting and archiving.

GLP principles are a set of standards for ensuring the quality, reliability and integrity of studies, the reporting of verifiable conclusions and the traceability of data.  To ensure this, companies must assign roles and responsibilities to staff in order to ensure good operational management of each study and to focus on those aspects of study execution (planning, monitoring, recording, reporting, archiving) that are of special importance for the whole study.  Since all these aspects are of equal importance for compliance with GLP guidelines, these requirements cannot be partially implemented and still claim GLP compliance.  No testing facility can claim GLP compliance if it has not implemented and does not comply with the full array of the GLP guidelines.

As far as pharmaceutical development is concerned, GLP's apply only to studies which:

1. are non-clinical, i.e. studies mostly performed on animals or in vitro, including the analytical aspects of such studies;

2. are designed to obtain data on the properties and/or the safety of items with respect to human health and/or the environment;

3. are intended to be submitted to a regulatory agency with the purpose of registering or licensing the tested compound or any product produced from it.

Generally, GLP requirements for non-clinical laboratory studies conducted to evaluate drug safety cover the following classes of studies:

1. Single dose toxicity studies

2. Repeated dose toxicity studies

3. Reproductive toxicity studies

4. Developmental studies

5. Genotoxicity studiesl

6. Carcinogenicity studie

7. Pharmaco/Toxicokinetic studies

8. Pivotal Pharmacodynamic studies

9. Local tolerance studies, including photosafety, irritation and sensitization studies, or testing for suspected addictive and/or withdrawal effects of drugs

GLP's apply to studies planned and conducted in a manufacturer’s laboratory, at a contract or subcontract facility, or in a university or public sector laboratory.  Adherence to GLP will legitimize overall credibility of a study.

Through the application of Standard Operating Procedures (SOP's), many sources of systematic errors or artifacts may be avoided.  The requirement to formulate a study plan with a defined scientific purpose for the study will prevent unsuccessful studies and diminish the incidence of incomplete or inconclusive studies.

The OECD Principles of Good Laboratory Practice is recognized by HPFB (Health Products and Food Branch) as the GLP standard in Canada.  Click Here to Find Out More >>