Life-Sciences-eQMS 15 Punkte
GLP Nonclinical Study Conduct Checklist (21 CFR 58)
Diese Checkliste ist auf Englisch.
Verifies that nonclinical safety studies are conducted under Good Laboratory Practice with proper study direction, protocol control, and QA oversight. Use for study file review and GLP facility inspection.
21 CFR 58OECD GLP Principles
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Organization and Personnel
- Is a single study director designated with overall responsibility for the study? *
- Is personnel education, training, and experience documented for assigned roles? *
- Is testing facility management responsibility (resources, QAU) established? *
Quality Assurance Unit
- Is there a Quality Assurance Unit independent of study conduct? *
- Does the QAU maintain a master schedule and inspect the study at intervals? *
- Does the final report include a signed QAU statement of inspection dates and findings reported to management? *
Protocol and SOPs
- Is there an approved written protocol signed by the study director before study start? *
- Are protocol changes documented, dated, and signed by the study director? *
- Are current standard operating procedures available for each study operation? *
Test Systems and Test Article
- Is the identity, strength, purity, and stability of the test/control article characterized? *
- Are animal care, housing, and test system handling documented per requirements? *
Raw Data and Records
- Are raw data recorded directly, promptly, legibly, dated, and signed by the recorder? *
- Are specimens, raw data, and the final report retained in archives with a designated archivist? *
Final Report
- Does the final report contain the study director's dated signature and required elements? *
- Record the date the final report was signed by the study director.
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