SOP for Internal Audits

Standard Operating Procedure for Internal Audits

1) Purpose

The purpose of this SOP is to establish procedures for planning, conducting, and reporting internal audits to verify compliance with regulatory requirements, quality standards, and organizational policies within the organization.

2) Scope

This SOP applies to all departments and functions within the organization responsible for conducting internal audits.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Internal Audit Manager:

Responsible for overseeing the internal audit program and conducting audits as per schedule.

3.2 Quality Assurance (QA) Specialist:

Responsible for reviewing and approving audit plans, reports, and corrective actions.

4) Procedure

4.1 Audit Planning:

4.1.1 Establish an Internal Audit Schedule based on organizational priorities and regulatory requirements.
4.1.2 Define audit scope, objectives, and criteria for each audit.
4.1.3 Identify audit team members and allocate resources for audit preparation.

4.2 Audit Execution:

4.2.1 Conduct entrance meetings with auditees to explain audit objectives, scope, and expectations.
4.2.2 Review documentation and records to assess compliance with applicable standards and procedures.
4.2.3 Perform interviews and observations to gather audit evidence.

4.3 Audit Reporting:

4.3.1 Prepare an Audit Report summarizing findings, observations, and non-conformities identified.
4.3.2 Include recommendations for corrective actions and improvements based on audit findings.
4.3.3 Obtain auditee feedback on draft Audit Report before finalizing and distributing.

4.4 Corrective Action and Follow-Up:

4.4.1 Assign corrective actions to address audit findings and non-conformities.
4.4.2 Monitor implementation of corrective actions and verify effectiveness.
4.4.3 Close audit findings upon completion of corrective actions and verification.

4.5 Audit Records and Documentation:

4.5.1 Maintain audit records, including Audit Reports, corrective action plans, and verification records.
4.5.2 Archive audit documentation in accordance with document retention policies.
4.5.3 Use audit findings for management review and continuous improvement initiatives.

5) Abbreviations, if any

QA – Quality Assurance

6) Documents, if any

1. Internal Audit Schedule
2. Audit Plan Template
3. Audit Report Template
4. Corrective Action Plan Form

7) Reference, if any

1. ISO 19011:2018 Guidelines for auditing management systems
2. FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations

8) SOP Version

Version 1.0