Supplier Auditing and Qualification Procedures

1) Purpose

The purpose of this SOP is to establish standardized procedures for auditing and qualifying suppliers of raw materials and components to ensure they meet specified quality standards and regulatory requirements.

2) Scope

This SOP applies to all suppliers of raw materials and components used in the pharmaceutical manufacturing facility.

3) Responsibilities

– Purchasing personnel are responsible for initiating supplier audits.
– QA personnel are responsible for conducting supplier audits and qualifying suppliers.
– QC personnel provide technical support during supplier evaluations.

4) Procedure

1. Supplier Selection
1.1. Identify potential suppliers based on business needs and product specifications.
1.2. Conduct a preliminary assessment of each supplier’s capability, quality systems, and regulatory compliance.
2. Pre-Audit Preparation
2.1. Notify the supplier of the planned audit and agree on a schedule.
2.2. Prepare an audit plan, including the audit scope, objectives, and checklist.
2.3. Gather relevant documents and records related to the supplier’s performance and previous audits, if applicable.
3. Conducting the Audit
3.1. Conduct an on-site audit of the supplier’s facilities, processes, and quality systems.
3.2. Use the audit checklist to evaluate key areas, such as:
3.2.1. Quality management system
3.2.2. Manufacturing processes
3.2.3. Quality control and testing
3.2.4. Documentation and record-keeping
3.2.5. Compliance with regulatory requirements
3.3. Document all observations, findings, and any non-conformances identified during the audit.
4. Audit Report
4.1. Prepare a detailed audit report summarizing the findings and observations.
4.2. Include an assessment of the supplier’s strengths and areas for improvement.
4.3. Assign a risk rating to the supplier based on the audit findings.
5. Supplier Qualification
5.1. Review the audit report and make a decision on supplier qualification.
5.2. If the supplier meets the required standards, qualify them as an approved supplier.
5.3. If the supplier does not meet the required standards, communicate the findings and required corrective actions to the supplier.
6. Corrective Actions and Follow-Up
6.1. If corrective actions are required, work with the supplier to develop a CAPA plan.
6.2. Monitor the implementation of corrective actions and conduct follow-up audits if necessary.
7. Documentation
7.1. Maintain all audit records, including the audit plan, checklist, audit report, and correspondence with the supplier.
7.2. Update the approved supplier list based on the audit results and qualification status.
8. Review and Approval
8.1. Submit the audit report and qualification decision to the QA department for review.
8.2. QA will review and approve the results, ensuring that all necessary actions have been taken and that the supplier meets the required standards.

5) Abbreviations, if any

– QA: Quality Assurance
– QC: Quality Control
– CAPA: Corrective and Preventive Actions

6) Documents, if any

– Supplier Audit Plan
– Supplier Audit Checklist
– Supplier Audit Report Form
– CAPA Report Form

7) Reference, if any

– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– ICH Q10 – Pharmaceutical Quality System

8) SOP Version

Version 1.0