The GLP requirements.
The GLP regulations were made to expose organizations doing the research to rigid standards in order to produce quality and reliable data. The idea of GLP is to create international standards to the point where the test data is acceptable and can be used among countries.
The main GLP requirements are:
- The management of the laboratory must ensure that qualified scientists work in appropriate facilities with appropriate equipment and materials. The qualifications of staff and the duties they perform must be recorded.
- The laboratories are required to establish quality control (QC). The quality control system should be documented and performed by the staff directly responsible for management. The quality control staff should not be involved in the studies.
- The study director has to agree with the plan and needs to seek authorization for any changes in the study plan.
- The laboratory workers must exercise safe working conditions, wear proper clothing for work, keep the workspace clean, label the workspace, stay focused and aware of their surroundings, and hand chemicals with suitable caution.
- The test facility should be suitable for the researches performed to minimize outside conditions that could interfere with the validity of any results.
- The substances for the studies should be kept in the proper facilities to avoid contamination. Waste disposal should not jeopardize the integrity of studies in progress. Waste collection, storage, and disposal facilities should be appropriate and the process of the waste collection must be documented.
- Sponsors and contract research organizations conducting non-clinical safety studies must comply with the U.S. law and regulations covering GLP.
The main difference between GLP and non-GLP studies is that non-GLP studies do not require all of the rigor of GLP studies.