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GLP Auditing
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| Sponsors of FDA-, EPA- and other regulatory agency-regulated products must submit evidence of the product’s safety in research and marketing applications. Any non-clinical laboratory facility used for this safety testing may be inspected by the appropriate agency prior to granting marketing authorization. Polaris can perform independent audits of non-clinical laboratories, whether at a Sponsor’s facility or a contract facility. Results of the audit can provide you with assurance that sites are in compliance with the regulations and that the non-clinical laboratory is ready for FDA or other agency inspection. Should the need for remediation be identified in the audit, Polaris’ auditors can recommend remedial actions.
Polaris will conduct GLP audits against the applicable regulations (e.g., 21 CFR 58) and any applicable Sponsor SOPs. Specifically, the following areas will be reviewed for compliance:
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- Organization, personnel
- Facilities
- Equipment
- Testing facilities operation
- Test and control articles
- Protocol
- Records, reports and record/sample retention
- QA unit
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200 Commonwealth Court, Suite 101 
