Supplier Audits – Standard Operating Procedure
1) Purpose
To establish guidelines for conducting supplier audits to assess compliance, quality systems, and capability within the pharmaceutical purchase department.
2) Scope
This SOP applies to planning, conducting, and reporting supplier audits to ensure suppliers meet regulatory and quality requirements.
3) Responsibilities
Quality Assurance Team: Responsible for planning, conducting, and documenting supplier audits.
Purchasing Team: Responsible for coordinating audit schedules and supplier communications.
4) Procedure
4.1) Audit Planning:
4.1.1) Identify suppliers for audit based on risk assessment and criticality.
4.1.2) Develop audit plans including scope, objectives, and audit checklist.
4.2) Pre-Audit Activities:
4.2.1) Notify suppliers of audit schedule, scope, and expectations.
4.2.2) Review supplier documentation including quality manuals, procedures, and previous audit reports.
4.3) On-Site Audit:
4.3.1) Conduct on-site audit activities including interviews, document reviews, and facility inspections.
4.3.2) Verify compliance with regulatory requirements and quality standards.
4.4) Audit Reporting:
4.4.1) Prepare audit reports documenting findings, observations, and non-conformances.
4.4.2) Share audit reports with suppliers for review and corrective action responses.
4.5) Follow-up and Closure:
4.5.1) Review supplier responses to audit findings and non-conformances.
4.5.2) Close audit findings upon verification of corrective actions and effectiveness.
4.6) Documentation and Records:
4.6.1) Maintain audit reports, correspondence, and records of audit findings and closures.
4.6.2) Archive audit documentation for regulatory inspections and reference.
5) Abbreviations, if any
N/A
6) Documents, if any
- Audit Plans and Checklists
- Audit Reports
- Supplier Communication Logs
- Corrective Action Plans and Verification Records
7) Reference, if any
Regulatory Guidelines: FDA CFR Part 211.22, ICH Q10
Industry Standards: ISO 9001:2015
8) SOP Version
Version 1.0