Standard Operating Procedure for Internal Audits

1) Purpose

The purpose of this SOP is to establish a procedure for conducting internal audits to verify compliance with regulatory requirements, company policies, and quality management systems.

2) Scope

This SOP applies to all departments and processes within the pharmaceutical manufacturing facility subject to internal audit.

3) Responsibilities

3.1 Quality Assurance (QA) Manager
– Plan and schedule internal audits.
– Ensure audit findings are addressed and closed within specified timelines.
3.2 Audit Team
– Conduct audits in accordance with this SOP and applicable audit protocols.
– Document audit findings accurately and objectively.
3.3 Department Heads
– Cooperate with auditors during audits.
– Implement corrective actions as directed based on audit findings.

4) Procedure

4.1 Audit Planning
4.1.1 Determine audit objectives, scope, and criteria based on regulatory requirements and company policies.
4.1.2 Prepare an audit schedule including audit dates, departments to be audited, and audit team members.
4.2 Audit Execution
4.2.1 Conduct opening meeting to introduce audit team, explain audit objectives, and outline audit process.
4.2.2 Review documents, records, and procedures to assess compliance with established criteria.
4.3 Audit Reporting
4.3.1 Document audit findings, including non-conformities and observations.
4.3.2 Prepare an audit report summarizing findings, conclusions, and recommendations.
4.4 Corrective Actions
4.4.1 Assign responsibility for corrective actions to address identified non-conformities.
4.4.2 Verify implementation and effectiveness of corrective actions through follow-up audits or reviews.
4.5 Audit Closure
4.5.1 Conduct closing meeting to discuss audit findings, conclusions, and any outstanding issues.
4.5.2 Obtain management approval of the audit report and closure of audit findings.

5) Abbreviations, if any

– QA: Quality Assurance

6) Documents, if any

– Audit Schedule
– Audit Reports
– Corrective Action Reports

7) Reference, if any

– FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations
– ICH Q10 Pharmaceutical Quality System

8) SOP Version

Version 1.0