Learn what is meant by Good Laboratory Practice, what are examples of Good Laboratory Practices, what is Good Laboratory Practice principles, what is GLP and GMP, and what are GLP requirements
Published 4 May 2022
Good Laboratory Practice (GLP) is a quality system covering the organizational process and conditions under which non-clinical laboratory studies are planned, performed, monitored, recorded, reported, and archived. GLP ensures the quality and integrity of safety test data submitted to the government for the issuance of research permits.
The difference between GMP and GLP is their scope. Good Manufacturing Practice applies to the entire drug manufacturing process while Good Laboratory Practice applies only to the safety testing phase. Both GMP and GLP are enforced by the Food and Drug Administration (FDA) in the United States.
Below is a table based on FDA guidance to help research laboratories determine if a specific study or activity must comply with Good Laboratory Practice:
GLP Compliance Required
GLP Compliance Not Required
GLP is also not required during early development stages such as discovery, screening, basic research, and concept assessment. According to the World Health Organization, GLP compliance is typically limited to Stage 2 of the drug development process.
Image source: WHO TDR GLP
Testing facility or test facility – the research laboratory conducting the non-clinical study
Test article or test item – the product being studied or tested; the subject of the study
Test system – these are:
Control article or reference item – a product that is:
Below are Good Laboratory Practice guidelines for the different elements of a study:
Before the study begins, the testing facility manager must appoint a study director who will be responsible for the overall conduct of the study and its GLP compliance. The testing facility must also have a Quality Assurance Unit (QAU) which is separate from or independent of the testing facility organization or management.
The testing facility should provide separation of activities to prevent interference and other disturbances which may compromise the study. There must be separate areas for:
All equipment used in the study should be periodically calibrated and maintained. Records of calibration and maintenance should be kept and made available to operators of equipment
Personnel performing the study should know the following about each test and control article:
The study plan or protocol is the master guidance document for the conduct of the study. It outlines how the study should be performed and contains the general time schedule for the study and its various stages. It also includes the method and materials used in the study.
The protocol must go through approval, review, and discussion before the study begins. This process starts with the study director preparing the protocol and discussing its contents with personnel and other study staff. After discussion, the study director must then approve the protocol by affixing their dated signature.
Once the protocol has been approved by the study director, it must be reviewed by the QAU, who will assess its compliance with Good Laboratory Practice. At this point in the process, personnel should be instructed on the duties assigned to them in the protocol as well as receive their own copies of the protocol.
Each of the separate areas in the testing facility should have Standard Operating Procedures (SOPs), especially for routine procedures. SOPs must be approved by the testing facility manager and any deviations from SOPs need to be authorized by the study director.
The final report is ultimately the responsibility of the study director, who prepares and approves the report. Key features of the final report are:
Throughout the course of the study, the study director will be responsible for ensuring that all data pertaining to the study is captured and included in records that are safely stored. These records and documents such as the protocol, the final report, and standard operating procedures will then be archived at the end of the study.
Only personnel authorized by the testing facility manager can access archived records. Additionally, every instance of records being accessed, removed from, or returned to the archives must be logged. It is also recommended that records in the archives be indexed for organized retrieval.
The required retention period for archived records varies depending on national GLP regulations. For research laboratories in the US, use the following guide questions based on Subpart J of 21 CFR Part 58 (“Good Laboratory Practice for Nonclinical Laboratory Studies”):
Below are general Good Laboratory Practice examples:
GLP regulations in the US, UK, and EU have similar GLP requirements since they are members of the Organization for Economic Co-operation and Development (OECD). This international organization developed the GLP principles used in many countries today.
iAuditor by SafetyCulture is a recognized quality management software that testing facility managers, study directors, and QA/QC professionals can use for GLP regulations compliance. iAuditor can be used at every step of the Good Laboratory Practice program, from preparing the study plan or protocol to submitting the final report for QA review.
iAuditor features for GLP regulations compliance:
Available as a web-based software and as a mobile app, iAuditor is free to download and has a free plan with all of the features mentioned above. Get started with iAuditor for free!
Study directors appointed by testing facility managers for non-clinical laboratory studies can use this template to comply with the study plan or protocol requirement of Good Laboratory Practice (GLP) regulations. Based on both FDA regulation and OECD principles, this template can be used to do the following:
Study directors appointed by testing facility managers for non-clinical laboratory studies can use this template to comply with the final report requirement of Good Laboratory Practice (GLP) regulations. Based on both FDA regulation and OECD principles, this template can be used to do the following:
Zarina is a content writer and researcher for SafetyCulture. She enjoys discovering new ways for businesses to improve their safety, quality, and operations. She is working towards helping companies become more efficient and better equipped to thrive through change.
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