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