Archives
The Archives that contain the raw data, documentation, and other materials generated during the conduct of a Good Laboratory Practice (GLP) study. Test Facility Management (TFM) ensures the management of archives and are used to reconstruct and validate the study in case of an audit or regulatory inspection.
- Raw data generated during the study
- Documentation of study procedures, including standard operating procedures (SOPs) and study plans
- Records of study personnel training, qualifications, and experience
- Reports generated during the study, including interim and final reports
- Correspondence related to the study, such as communications with the sponsor or regulatory agency
The Archives have physical and access control and located in the secure place to prevent loss or damage of data, and access is limited to authorized personnel only.
The archives maintained for a specified period, depending on the regulatory requirements of the country where the study was conducted. In general, the archives should be retained for a minimum of nine years after the study is completed.
Maintaining OECD GLP archives is a critical part of ensuring the integrity of GLP studies and complying with regulatory requirements and making them available for regulatory inspection when required.
