Principles and General Guidelines of Good Laboratory Practice
Good laboratory practice or GLP is a set of principles envisioned to assure the quality and truthfulness of non-clinical laboratory studies that are planned to support research or marketing permits for products structured by government agencies. The GLP is mostly accompanied by the pharmaceutical industry and the required non-clinical animal testing that must be performed before the approval of new medication products. However, GLP applies to many other non-pharmaceutical representatives such as colour essences, food essences, food contamination limits, food packaging, and medical devices. Before getting into the GLP general guidelines, identify the principles of good laboratory practice.
- Test Facility Organization and Personnel
- Quality Assurance Program
- Facilities
- Apparatus, Material, Reagents
- Test Systems
- Test and Reference Items
- Standard Operating Procedures
- Performance of the Study
- Reporting of Study Results
- Storage and Retention of Records and Materials
Personnel: The testing facility manager must nominate a study director before the study officially begins. The person will be in authority of the study's overall management and GLP compliance. A
Quality Assurance Unit (QAU) that is separated or independent from the testing facility organization or administration also was required.
Facility & Equipment: To avoid interference and other disturbances that can jeopardize the study, the testing facility should maintain isolation of operations. Separate places must be:
- the receipt and storage of the test and control object
- the mixing of the test and control object with a carrier
- the storage of the test and control object mixtures
- the covering of the test systems
Characterization: The following information about each test and control item should be known by those involved in the study:
- identity, purity, composition, and stability
- date of receipt, expiry date, and storage instructions
- quantity received and quantity used
Standard Operating Procedures: The testing facility should have Standard Operating Procedures (SOPs) for each of its several departments, especially for common tasks. The manager of the testing facility must approve SOPs, and the study director must give permission for any deviations from SOPs.
Final Report: The study director, who develops and approves the report, is ultimately in charge of the final report. The final report's main components are:
- a complete and accurate explanation of the conduct of the study
- any deviation from an intended course of action (such as SOP or protocol)
- scientific interpretation of results and critical discussion
- GLP Compliance Statement by the study director
Retention of Records: Depending on national GLP regulations, the necessary storage duration for archived records varies.

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