Standard Operating Procedure for Vendor Audits

Purpose

The purpose of this SOP is to establish procedures for auditing and evaluating vendors and suppliers of pharmaceutical products to ensure compliance with quality standards, regulatory requirements, and contractual agreements.

Scope

This SOP applies to all personnel involved in vendor management, procurement, quality assurance, and warehouse operations within the pharmaceutical facility.

Responsibilities

• Procurement Department: Responsible for vendor selection, contract negotiation, and vendor relationship management.
• Quality Assurance Department: Responsible for conducting vendor audits, evaluating vendor performance, and ensuring compliance with quality standards.
• Warehouse Managers: Responsible for implementing vendor audit procedures and ensuring that vendors comply with warehouse requirements.
• Vendor Auditors: Responsible for planning, conducting, and documenting vendor audits in accordance with this SOP.

Procedure

1. Vendor Selection and Pre-qualification:
   • Establish criteria for vendor selection based on factors such as product quality, reliability, reputation, and compliance with regulatory requirements.
   • Conduct pre-qualification assessments of potential vendors to verify their capabilities, facilities, and compliance with applicable standards.
   • Maintain a list of approved vendors and suppliers based on pre-qualification results and ongoing performance evaluations.
2. Vendor Audit Planning:
   • Develop a risk-based audit schedule to prioritize vendors for audit based on factors such as criticality, past performance, and regulatory requirements.
   • Define audit objectives, scope, and criteria for each audit based on the nature of the vendor’s products, services, and associated risks.
   • Notify vendors in advance of upcoming audits and request necessary documentation and access to facilities for audit purposes.
3. Vendor Audit Execution:
   • Conduct on-site or remote audits of vendor facilities, processes, and quality management systems using standardized audit protocols and checklists.
   • Interview key personnel, observe operations, and review documentation to assess compliance with quality standards, regulatory requirements, and contractual agreements.
   • Document audit findings, observations, and non-conformities identified during the audit process, and discuss preliminary findings with vendor representatives as needed.
4. Vendor Audit Reporting and Follow-Up:
   • Prepare comprehensive audit reports summarizing audit findings, observations, and recommendations for corrective actions.
   • Review audit reports with vendor representatives to ensure mutual understanding of findings and corrective action requirements.
   • Track and monitor the implementation of corrective actions by vendors, follow up on outstanding issues, and verify the effectiveness of corrective measures through follow-up audits or inspections.

Abbreviations

• SOP: Standard Operating Procedure

Documents

• Vendor Audit Plan
• Audit Checklist
• Audit Report
• Corrective Action Plan
• Follow-Up Audit Report

SOP Version

Version 1.0