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Vendor Audits

Vendor/Supplier Qualification is the process of evaluating and approving potential suppliers by quantitative assessment and by which to measure and monitor existing vendor performance for the purposes of reducing costs, mitigating risk and driving continuous improvement. Vendor audits, also known as supplier audits, are assessments that a firm completes as part of the qualification process. Depending on the design of the vendor qualification program, these audits are performed on-site, off-site, and in some cases both.

WHO SHOULD DO VENDOR AUDITS?

Industry Code of Federal Regulation (CFR) References
Pharmaceutical 21 CFR 211.84, 21 CFR 211.184
Medical Device 21 CFR 820.80, 21 CFR 820.50
Dietary Supplement 21 CFR 111.70, 21 CFR 111.75, 21 CFR 111.80, 21 CFR 111.95, 21 CFR 111.105, 21 CFR 111.123, 21 CFR 111.155, 21 CFR 111.165, 21 CFR 111.180

COMPONENTS OF A VENDOR QUALIFICATION PROGRAM

  • SOP(s)
  • Requirements Documentation
  • Vendor Files
  • Assessment Forms and Checklists
  • Approved Vendor Lists
  • Requalification Schedules

COMMON ISSUES, MISTAKES AND PITFALLS

  • Not having clearly defined requirements before assessing vendors
  • Poor or insufficient documentation of the assessments
  • Outdated approved vendor lists
  • Use of contract laboratories without qualification
  • Continued use of vendors with history of non-compliance without corrective actions

EXAMPLES OF THE HELP RELIANT CAN PROVIDE

  • Build a Sustainable Vendor Audit Program
  • Audit, Assess, and Provide Recommendations on an Existing Vendor Audit Program
  • Audit/Qualify Vendors
  • Perform a Vendor Qualification Status Gap Assessment

ASSOCIATED JOURNAL ARTICLES AND COMPLIANCE TIPS

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