Standard Operating Procedure for Vendor Audits and Assessments

1) Purpose

This SOP outlines the procedures for conducting audits and assessments of vendors to ensure they comply with regulatory requirements and the company’s quality standards for the materials and services they provide.

2) Scope

This SOP applies to all vendors supplying materials, components, and services that impact the quality of pharmaceutical products manufactured by the company.

3) Responsibilities

The Quality Assurance (QA) department is responsible for planning, conducting, and reporting vendor audits and assessments. The Purchasing department collaborates with QA to ensure that only qualified vendors are selected and maintained.

4) Procedure

4.1 Audit Planning

1. Develop an annual vendor audit schedule based on risk assessment, criticality of the materials or services provided, and previous performance.
2. Select the audit team, comprising personnel with the relevant expertise and experience.
3. Prepare an audit plan and checklist tailored to the specific vendor and scope of the audit.

4.2 Pre-Audit Activities

1. Notify the vendor of the upcoming audit and provide the audit plan and checklist.
2. Request and review relevant documents from the vendor, including quality manuals, certifications, and previous audit reports.
3. Conduct a pre-audit meeting with the audit team to discuss objectives, roles, and responsibilities.

4.3 On-Site Audit

1. Conduct an opening meeting with the vendor’s management to explain the audit scope, objectives, and process.
2. Review the vendor’s facilities, processes, and quality management systems against the audit checklist.
3. Interview key personnel and observe critical processes to gather evidence of compliance.
4. Document all observations, findings, and any non-conformances noted during the audit.
5. Conduct a closing meeting to present preliminary findings and discuss potential corrective actions.

4.4 Post-Audit Activities

1. Prepare a detailed audit report summarizing the findings, including areas of compliance and non-compliance.
2. Classify audit findings based on their severity (e.g., critical, major, minor).
3. Send the audit report to the vendor and request a corrective and preventive action (CAPA) plan for any non-conformances.

4.5 Corrective and Preventive Actions (CAPA)

1. Review the vendor’s CAPA plan to ensure it adequately addresses the audit findings.
2. Monitor the implementation of the CAPA plan and verify the effectiveness of corrective actions through follow-up audits or assessments.
3. Document the closure of audit findings and update the vendor’s status in the supplier management system.

4.6 Ongoing Vendor Assessment

1. Regularly review the performance of approved vendors based on quality, delivery, and service metrics.
2. Conduct periodic requalification audits to ensure continued compliance with quality and regulatory requirements.
3. Document any issues or deviations in vendor performance and initiate corrective actions as necessary.

4.7 Documentation and Records

1. Maintain complete and accurate records of all vendor audit and assessment activities, including audit plans, checklists, reports, and CAPA documentation.
2. Ensure that all documentation is readily accessible for audits and regulatory inspections.

5) Abbreviations, if any

QA: Quality Assurance
SOP: Standard Operating Procedure
CAPA: Corrective and Preventive Actions

6) Documents, if any

Audit Plans, Audit Checklists, Audit Reports, CAPA Plans, Vendor Performance Reviews

7) Reference, if any

Regulatory guidelines such as FDA, EMA, ICH Q9 (Quality Risk Management), ICH Q10 (Pharmaceutical Quality System), and ISO 9001 (Quality Management Systems)

8) SOP Version

Version 1.0