Supplier Non-Conformance Handling – Standard Operating Procedure
1) Purpose
To establish guidelines for handling and resolving non-conformances related to materials or services supplied by vendors within the pharmaceutical purchase department.
2) Scope
This SOP applies to handling non-conformances identified during supplier-related activities within the pharmaceutical purchase department.
3) Responsibilities
Purchasing Team: Responsible for initiating non-conformance reports (NCRs) and coordinating resolution.
Quality Assurance Team: Responsible for investigating and approving corrective actions.
4) Procedure
4.1) Non-Conformance Identification:
4.1.1) Identify non-conformances through inspection, testing, or internal audits.
4.1.2) Document non-conformance details including nature, severity, and affected materials.
4.2) Non-Conformance Report (NCR) Initiation:
4.2.1) Initiate NCR using standardized form or electronic system.
4.2.2) Include details of non-conformance, affected materials, and potential impact on product quality or safety.
4.3) Investigation and Root Cause Analysis:
4.3.1) Conduct investigation to determine root cause(s) of non-conformance.
4.3.2) Verify findings and impact on product quality or compliance.
4.4) Corrective and Preventive Actions (CAPA):
4.4.1) Develop CAPA plan to address root cause(s) and prevent recurrence.
4.4.2) Implement corrective actions promptly and monitor effectiveness.
4.5) Supplier Communication:
4.5.1) Notify supplier of non-conformance and required corrective actions.
4.5.2) Collaborate with supplier to resolve issues and prevent future occurrences.
4.6) Documentation and Records:
4.6.1) Document NCR details, investigation findings, and CAPA activities.
4.6.2) Maintain records of communications with suppliers and approval of corrective actions.
5) Abbreviations, if any
NCR – Non-Conformance Report
6) Documents, if any
- Non-Conformance Reports (NCRs)
- Root Cause Analysis Reports
- CAPA Plans and Records
- Supplier Communication Logs
7) Reference, if any
Regulatory Guidelines: FDA CFR Part 211.192, ICH Q9
Industry Standards: ISO 9001:2015
8) SOP Version
Version 1.0
