eQMS Ilmu Hayati 14 butir
CRO / Supplier Qualification & Oversight Checklist
Daftar periksa ini dalam bahasa Inggris.
Evaluates qualification and ongoing oversight of contract research organizations, contract manufacturers, and material suppliers. Use during vendor onboarding and periodic performance review.
21 CFR 820.50ICH E6(R2) 5.2ICH Q10ICH Q7 7
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Qualification and Selection
- Was the supplier/CRO evaluated and selected based on defined quality requirements? *
- Does the sponsor retain ultimate responsibility for the quality of outsourced activities? *
- Is the supplier risk classified (critical vs. non-critical) with justification? *
Quality/Technical Agreement
- Is a written quality agreement in place defining GMP/GCP responsibilities of each party? *
- Does the agreement address change notification, deviation, and complaint handling? *
- Are data ownership, record retention, and audit rights specified? *
Audit and Assessment
- Was an on-site or documented audit performed prior to qualification? *
- Record the date of the most recent supplier/CRO audit.
- Are audit findings tracked to closure with CAPA where needed? *
Ongoing Oversight (CRO Monitoring)
- Is there a risk-based monitoring plan for outsourced clinical/trial activities? *
- Are supplier performance metrics (on-time delivery, quality, deviations) trended? *
- Are periodic requalification reviews performed on the defined interval? *
Incoming Material Control
- Are incoming materials from suppliers inspected, tested, or verified before use? *
- Is an approved supplier list (ASL) maintained and current? *
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