Standard Operating Procedure for Supplier Qualification and Quality Audits
1) Purpose
This SOP defines the process for qualifying suppliers and conducting regular quality audits to ensure that materials meet GMP requirements and product quality standards.
2) Scope
This SOP applies to all personnel involved in the evaluation, qualification, and auditing of suppliers at [Company Name].
3) Responsibilities
- Purchasing Department: Identify and evaluate potential suppliers based on quality standards.
- Quality Assurance (QA): Conduct supplier audits and review supplier documentation to ensure compliance with GMP regulations.
4) Procedure
4.1 Supplier Qualification Process
4.1.1 Supplier Evaluation
- Identify potential suppliers and evaluate their ability to provide materials that meet GMP standards. Evaluate suppliers based on their quality management systems, regulatory compliance, and history of supply performance.
4.1.2 Documentation Review
- Review documentation from the supplier, including Certificates of Analysis (COAs), product specifications, and GMP certifications. Document all reviews in the supplier qualification log.
4.1.3 Supplier Approval
- Approve suppliers that meet GMP standards and product specifications. Document the approval in the supplier qualification log and maintain records for auditing purposes.
4.2 Supplier Quality Audits
4.2.1 Audit Planning
- QA will develop an annual audit
schedule based on the criticality of the supplier and the materials supplied. Plan audits for key suppliers at least once per year.
4.2.2 Conducting the Audit
- Conduct on-site audits or remote documentation audits to evaluate the supplier’s GMP compliance. Use a standard audit checklist to assess the supplier’s quality systems, documentation, and production processes.
4.2.3 Audit Findings and Corrective Actions
- Document any findings during the audit and communicate them to the supplier. Suppliers must submit corrective action plans for any deficiencies identified during the audit.
- Record all findings and corrective actions in the audit report. Submit the report for QA review and approval.
4.3 Post-Audit Activities
4.3.1 Ongoing Supplier Monitoring
- QA will continue to monitor supplier performance, reviewing incoming materials for compliance with specifications. Any issues must be documented and addressed with the supplier immediately.
4.3.2 Documentation
- Document all supplier qualifications, audit findings, and corrective actions in the supplier qualification log. Maintain records for at least five years.
5) Abbreviations, if any
- GMP: Good Manufacturing Practices
- QA: Quality Assurance
- COA: Certificate of Analysis
6) Documents, if any
- Supplier Qualification Log
- Audit Report
7) References, if any
- Internal SOP for supplier audits
8) SOP Version
Version 1.0
Annexure
1. Supplier Qualification Log Template
| Date | Supplier Name | Materials Supplied | GMP Compliance Status | QA Approval |
|---|---|---|---|---|
| DD/MM/YYYY | Supplier Name | Materials Description | Compliance Status | QA Name |