Laboratories · Quality Control · Advanced
FDA 21 CFR Part 58 GLP self-assessment checklist covering organisation, QAU, facilities, SOPs, and study conduct.
FDA's Good Laboratory Practice regulations (21 CFR Part 58) ensure the quality and integrity of non-clinical laboratory studies submitted in support of FDA applications. This checklist covers the key requirements: management responsibilities, QAU function, facilities, equipment, testing facility operations, test article handling, study protocol, reporting, and data retention.
Use this checklist for internal GLP readiness or preparation for FDA bioresearch monitoring (BIMO) inspections. Systematic self-audits identify compliance gaps before they become FDA 483 observations.
This checklist template is provided as a general-purpose resource and is not tailored to the regulatory requirements of any specific country, region, or jurisdiction. It is the responsibility of each organisation to review and adapt this template to ensure compliance with all applicable local laws and regulations. Miratag does not accept liability for any inaccuracies or omissions, or for any actions taken based on this template.
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