Good Laboratory Practice
Good laboratory practice or GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies. The term GLP is most commonly associated with the pharmaceutical industry and the required non-clinical animal testing that must be performed prior to approval of new drug products. However, GLP applies to many other non-pharmaceutical agents such as colour additives, food additives, food contamination limits, food packaging, and medical devices.
Primary Benefit of GLP
The primary benefit of following current Good Laboratory Practice is the creation of a document trail providing traceability for all measurements. This leads to the creation of technically defendable scientific data, by which its quality, reliability and trustworthiness can be assured.
Other Benefits of GLP
This in turn will lead to many other benefits for both the laboratory and its customers, including:
Increased confidence in the reliability and trustworthiness of laboratory data
Increased production of right first time results
Increased overall productivity
Increased laboratory reputation
Reduced need for re-work
Reduced time spent on non-revenue earning investigations
- Organization and Personnel – Responsibilities – Management, Sponsor, Study Director, Principal Investigator & Study Personnel
- Quality assurance program – Quality Assurance Personnel
- Facilities – Test System Facilities & Facilities for Test and Reference Items
- Equipment, reagents and Materials
- Test systems – Physical, Chemical & Biological
- Test & Reference items
- Standard operating procedures
- Performance of Study – Study Plan & Conduct of Study
- Reporting of results
- Archival – Storage of Records and Reports
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European Assessment and Certification Ltd.
19, Layton Crescent, Slough, SL38DP, UK.
Company Number 12819256
+44 7471 048859