Standard Operating Procedure for Internal Audits and Self-Inspections

Purpose

The purpose of this SOP is to establish procedures for conducting internal audits and self-inspections within the pharmaceutical distribution facility, ensuring compliance with regulatory requirements, identifying areas for improvement, and maintaining quality standards.

Scope

This SOP applies to all personnel involved in the planning, execution, and follow-up of internal audits and self-inspections, including quality assurance professionals, department heads, and senior management.

Responsibilities

• The Quality Assurance Manager is responsible for overseeing internal audit and self-inspection activities and ensuring compliance with regulatory requirements and company standards.
• Department Heads are responsible for facilitating internal audits and self-inspections within their respective departments and providing necessary support and information to auditors.
• All personnel are responsible for cooperating with internal auditors, providing accurate and truthful information, and addressing any findings or recommendations identified during audits.

Procedure

1. Planning and Preparation:
   • Develop an annual audit plan outlining the schedule, scope, and objectives of internal audits and self-inspections based on regulatory requirements and company priorities.
   • Formulate audit teams comprising qualified personnel with relevant expertise and knowledge of audit procedures and standards.
2. Audit Execution:
   • Conduct internal audits and self-inspections according to the established audit plan, following predefined audit procedures and checklists.
   • Review documented processes, procedures, and records to assess compliance with regulatory requirements, company policies, and industry standards.
3. Findings and Recommendations:
   • Document audit findings, observations, and non-conformances identified during audits, including their severity and potential impact on quality and compliance.
   • Generate audit reports summarizing findings and recommendations for corrective and preventive actions (CAPAs) to address identified issues and improve processes.
4. Corrective Action:
   • Implement corrective actions in response to audit findings and recommendations, assigning responsibilities, establishing timelines, and tracking progress to resolution.
   • Verify the effectiveness of corrective actions through follow-up audits or reviews to ensure that identified issues have been adequately addressed.
5. Continuous Improvement:
   • Use audit findings and lessons learned to identify opportunities for process improvement and enhance quality management systems within the organization.
   • Review and update audit procedures and checklists periodically to reflect changes in regulatory requirements, industry best practices, and organizational needs.

Abbreviations

• SOP – Standard Operating Procedure
• CAPA – Corrective and Preventive Actions

Documents

Reference documents related to internal audits and self-inspections may include:

• Audit plan
• Audit reports
• Corrective action plans
• Follow-up audit reports
• Regulatory guidelines on auditing and self-inspection

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0