GLP (Good Laboratory Practices) is a quality system for organizational processes and management controls under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported (21 CFR Part 58 and OECD principles).
Most of the time GLP studies are contracted out to subcontractors by the sponsor where the responsibility of the whole study remains with the study director, including the validity of raw data and report. The sponsor is the entity that initiates and supports (financially or other resources), non-clinical health and environmental safety studies and also directly submits study results to regulatory authorities in support of a product registration. Therefore, the sponsor is responsible for confirming that all non-clinical health and environmental safety studies were conducted in compliance with GLP.
What is the responsibility of the sponsor in the GLP study management?
First and foremost, the sponsor should understand the requirements of the principals of GLP. This can be achieved by providing GLP training to staff involved in managing GLP studies. The sponsor should ensure that the test facility is able to conduct the study in compliance with GLP and is aware that the study is to be performed under GLP. This can be achieved by conducting audits of GLP laboratories prior to study initiation as well as monitoring during the study based on the nature, length, and complexity of the study. Also, the sponsor should ensure that adequate communication links are established between sponsors, the study director, test facility management, and the QA of the test facility.
Where the test item is supplied by sponsors?
Where the test item is supplied by sponsors, the test facility should ensure the ID of the test article, using the agreed-upon method. In addition, the sponsor must provide relevant safety data and characterization of test items for the registration package. Study protocol/plan and reports should be reviewed by the sponsor to ensure that it contains the name and address of the sponsor and testing facility. The study plan should also include the signature and approval date of test facility management and sponsor (if required by legislation).
Storage and Archival of Retention Samples and Records
Responsibility for the Storage and archival of retention samples and records should be described in the Quality agreement. There should be an agreed location for the archival material including data and samples. The material and data should be transferred to the sponsor if the contract organization’s business changes.
Submission to Regulatory Authorities
The ultimate responsibility of the scientific validity of a study lies with the study director, and not with the sponsor. The sponsor is responsible for making decisions based on the outcome of the study, whether or not to submit a product for registration to regulatory authorities. Where several studies are presented to a regulatory authority in a single package, the responsibility for the integrity of the package of unaltered final reports lies with the sponsor.