Internal Audits – Standard Operating Procedure

1) Purpose

To establish guidelines for planning, conducting, reporting, and following up on internal audits to verify compliance with regulatory requirements and company policies within the pharmaceutical manufacturing department.

2) Scope

This SOP applies to all internal audit activities conducted to assess the effectiveness of the quality management system and identify areas for improvement.

3) Responsibilities

Quality Assurance Team: Responsible for planning and executing internal audits.
Department Managers: Responsible for implementing corrective actions based on audit findings.

4) Procedure

4.1) Audit Planning:
4.1.1) Develop an annual audit schedule based on risk assessments and regulatory requirements.
4.1.2) Identify audit criteria, scope, objectives, and team members.

4.2) Conducting Audits:
4.2.1) Conduct opening meetings to communicate audit objectives, scope, and expectations.
4.2.2) Review documents, records, and procedures against established audit criteria.

4.3) Audit Reporting:
4.3.1) Prepare audit reports documenting findings, observations, and non-conformances.
4.3.2) Include recommendations for corrective and preventive actions (CAPA) in the audit report.

4.4) Corrective Actions:
4.4.1) Assign responsibility for implementing corrective actions based on audit findings.
4.4.2) Verify and validate effectiveness of corrective actions through follow-up audits.

4.5) Audit Follow-up:
4.5.1) Review and close out audit findings after verifying completion of corrective actions.
4.5.2) Document audit outcomes and lessons learned for continuous improvement.

4.6) Documentation and Records:
4.6.1) Maintain audit schedules, plans, checklists, reports, and records of corrective actions.
4.6.2) Archive audit documentation for regulatory inspections and management reviews.

5) Abbreviations, if any

CAPA – Corrective and Preventive Actions

6) Documents, if any

• Internal Audit Schedule
• Audit Checklists and Reports
• Corrective Action Plans (CAPA)
• Audit Follow-Up Reports

7) Reference, if any

Regulatory Guidelines: FDA CFR Part 211.22, ISO 19011:2018
Industry Standards: Good Manufacturing Practice (GMP)

8) SOP Version

Version 1.0