1) SOP for Vendor Qualification and Audit

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish procedures for assessing and qualifying suppliers, as well as conducting regular supplier audits to ensure compliance with quality standards and regulatory requirements.

3) Scope

This SOP applies to all vendors supplying raw materials, components, and services to the pharmaceutical manufacturing facility.

4) Responsibilities

• Procurement Department: Responsible for identifying potential suppliers and initiating the qualification process.
• Quality Assurance (QA) Department: Responsible for conducting supplier audits and evaluating supplier performance.
• Vendor Management Team: Responsible for maintaining vendor records and monitoring ongoing compliance.

5) Procedure

1. Supplier Identification
   1. Identify potential suppliers based on business needs, product specifications, and regulatory requirements.
   2. Obtain information about the supplier’s capabilities, quality systems, and regulatory compliance status.
2. Supplier Qualification
   1. Request detailed information from the supplier, including quality certifications, manufacturing processes, and product specifications.
   2. Conduct a preliminary evaluation of the supplier’s documentation and capabilities.
   3. Schedule an initial audit of the supplier’s facilities and quality systems.
   4. Prepare an audit plan outlining the scope, objectives, and criteria for the supplier audit.
3. Supplier Audit
   1. Conduct the supplier audit according to the audit plan, focusing on key areas such as quality control, manufacturing processes, and regulatory compliance.
   2. Document audit findings and identify any non-conformances or areas for improvement.
   3. Discuss audit findings with the supplier and agree on corrective actions and timelines for implementation.
   4. Prepare an audit report summarizing the findings, corrective actions, and conclusions.
4. Supplier Approval
   1. Evaluate the supplier’s response to audit findings and the effectiveness of corrective actions.
   2. Make a decision on supplier approval based on the audit report and corrective action plan.
   3. Notify the supplier of the approval decision and any conditions or requirements for continued qualification.
   4. Maintain records of the supplier qualification process, including audit reports, corrective actions, and approval decisions.
5. Ongoing Supplier Management
   1. Monitor supplier performance through regular reviews of quality, delivery, and service metrics.
   2. Conduct periodic re-audits of suppliers to ensure continued compliance with quality standards and regulatory requirements.
   3. Address any issues or non-conformances identified during supplier reviews or audits and implement corrective actions as needed.
   4. Maintain an updated database of qualified suppliers and their performance records.

6) Abbreviations, if any

• QA: Quality Assurance
• SOP: Standard Operating Procedure

7) Documents, if any

• Supplier Qualification Questionnaire
• Supplier Audit Checklist
• Audit Reports
• Corrective Action Plans
• Supplier Performance Review Records

8) Reference, if any

• International Organization for Standardization (ISO) Standards
• Good Manufacturing Practices (GMP) Guidelines
• Company-specific vendor qualification policies

9) SOP Version

Version 1.0