Supplier Corrective Action Requests – Standard Operating Procedure

1) Purpose

To establish guidelines for requesting corrective actions from suppliers to address non-conformances and improve performance within the pharmaceutical purchase department.

2) Scope

This SOP applies to requesting and managing corrective actions requested from suppliers following non-conformance incidents.

3) Responsibilities

Purchasing Team: Responsible for initiating and managing corrective action requests (CARs).
Quality Assurance Team: Responsible for reviewing and approving supplier corrective actions.

4) Procedure

4.1) Non-Conformance Identification:
4.1.1) Identify non-conformances requiring corrective action through internal audits, inspections, or customer complaints.
4.1.2) Document non-conformance details and potential impact on product quality or compliance.

4.2) Corrective Action Request (CAR) Initiation:
4.2.1) Initiate CAR using standardized form or electronic system.
4.2.2) Include details of non-conformance, affected materials, and desired corrective actions.

4.3) Supplier Notification:
4.3.1) Notify supplier of identified non-conformance and request for corrective actions.
4.3.2) Provide clear instructions and timelines for submitting proposed corrective actions.

4.4) Evaluation and Approval:
4.4.1) Evaluate supplier-proposed corrective actions against effectiveness criteria.
4.4.2) Approve or reject proposed corrective actions based on thorough review and analysis.

4.5) Implementation and Verification:
4.5.1) Monitor implementation of approved corrective actions by supplier.
4.5.2) Verify effectiveness through follow-up inspections, tests, or audits as necessary.

4.6) Documentation and Records:
4.6.1) Document CAR details, evaluation results, and implementation status.
4.6.2) Maintain records of communications with suppliers and approval of corrective actions.

5) Abbreviations, if any

CAR – Corrective Action Request

6) Documents, if any

• Corrective Action Requests (CARs)
• Supplier Communication Logs
• Corrective Action Plans and Reports
• Verification Records

7) Reference, if any

Regulatory Guidelines: FDA CFR Part 211.100, ICH Q10
Industry Standards: ISO 9001:2015

8) SOP Version

Version 1.0