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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.

  1. A study is performed according to the sponsor’s requirements as stipulated in the study protocol.

  2. The analysis process is performed by trained personnel.

  3. A study is performed according to current standard operating procedures.

  4. Samples, test substances, raw data, final reports and analytical standards are archived properly.

  5. 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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