Standard Operating Procedure for Internal Audits

1) Purpose

The purpose of this SOP is to establish a procedure for conducting internal audits to ensure compliance with regulatory requirements, internal policies, and quality standards.

2) Scope

This SOP applies to all areas and processes within the manufacturing facility that are subject to internal audits.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Internal Auditors:

Responsible for planning, conducting, and reporting on internal audits.

3.2 Department Managers:

Responsible for facilitating audits and implementing corrective actions for any identified non-conformances.

3.3 Quality Assurance (QA) Manager:

Responsible for overseeing the internal audit program and ensuring compliance with regulatory requirements.

4) Procedure

4.1 Audit Planning:

4.1.1 Develop an annual internal audit schedule based on risk assessments and regulatory requirements.
4.1.2 Select areas and processes to be audited according to the schedule.
4.1.3 Notify relevant personnel of upcoming audits.

4.2 Conducting Audits:

4.2.1 Prepare audit checklists based on relevant regulations, standards, and internal policies.
4.2.2 Conduct audits according to the prepared checklists.
4.2.3 Document findings, including any non-conformances or areas for improvement.

4.3 Reporting and Documentation:

4.3.1 Prepare audit reports summarizing findings and recommendations.
4.3.2 Distribute audit reports to relevant personnel.
4.3.3 Document all audit activities and findings in the Internal Audit Log.

4.4 Corrective and Preventive Actions (CAPA):

4.4.1 Develop CAPA plans to address identified non-conformances.
4.4.2 Implement CAPA plans promptly.
4.4.3 Monitor the effectiveness of CAPA plans and make adjustments as necessary.
4.4.4 Document all CAPA activities and outcomes.

4.5 Follow-Up Audits:

4.5.1 Schedule follow-up audits to verify the implementation and effectiveness of CAPA plans.
4.5.2 Document the results of follow-up audits.

5) Abbreviations, if any

QA – Quality Assurance
CAPA – Corrective and Preventive Actions

6) Documents, if any

1. Internal Audit Schedule
2. Audit Checklists
3. Audit Reports
4. Internal Audit Log
5. CAPA Records

7) Reference, if any

1. FDA Guidance on Good Manufacturing Practices (GMP)
2. ISO 9001 Quality Management Systems

8) SOP Version

Version 1.0