GLP COMPLIANCE PROGRAM
NCL is fully compliant with federal Good Laboratory Practice Standards. The laboratory has been audited by EPA and quality assurance professionals from a variety of sponsors.
NCL’s GLP compliance program is designed to maintain laboratory compliance with GLP regulations as set forth in 40 CFR section 160. This program consists of a set of procedures which ensure that all events during the course of a study are thoroughly documented and that this documentation is properly archived. These procedures are also intended to make certain the following conditions are met.
- A study is performed according to the sponsor’s requirements as stipulated in the study protocol.
- The analysis process is performed by trained personnel.
- A study is performed according to current standard operating procedures.
- Samples, test substances, raw data, final reports and analytical standards are archived properly.
- The study is reconstructable.
Although the PSI is responsible for GLP compliance during the course of a particular study, the Quality Assurance Unit provides an independent assessment of study compliance... QAU personnel conduct protocol, sample receipt, in-process, raw data and final report audits on each critical phase for every study. In addition, detailed semi-annual facility inspections of each laboratory are performed. All findings are reported directly to the PSI and management.
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