Standard Operating Procedure for Internal Quality Audits

1) Purpose

This SOP outlines the procedures for conducting internal quality audits to assess compliance with established quality management systems, identify areas for improvement, and ensure adherence to regulatory requirements.

2) Scope

This SOP applies to all departments and functions within the company subject to internal quality audits, including manufacturing, quality assurance, regulatory affairs, and support functions.

3) Responsibilities

The Quality Assurance (QA) department is responsible for planning, scheduling, conducting, and reporting on internal quality audits. All departments and personnel are responsible for cooperating with audit activities and implementing corrective actions as necessary.

4) Procedure

4.1 Audit Planning

1. Develop an Annual Audit Schedule based on risk assessment, regulatory requirements, and previous audit findings.
2. Identify audit criteria, scope, objectives, and audit team members.
3. Notify auditees and schedule audit dates.

4.2 Audit Preparation

1. Review relevant documents, procedures, and records related to the area to be audited.
2. Prepare an Audit Checklist based on applicable standards, regulations, and company procedures.
3. Conduct an opening meeting to explain the audit objectives, scope, and process to auditees.

4.3 Audit Execution

1. Conduct on-site audits, interviewing personnel, reviewing documents, and observing processes.
2. Use the Audit Checklist to record observations, findings, and non-conformances.
3. Discuss findings with auditees as they arise to ensure clarity and understanding.

4.4 Reporting and Follow-Up

1. Prepare an Audit Report summarizing audit findings, observations, and non-conformances.
2. Assign Corrective and Preventive Actions (CAPAs) for identified non-conformances.
3. Share the Audit Report with auditees and management for review and approval.

4.5 CAPA Implementation and Verification

1. Monitor the implementation of CAPAs to address identified non-conformances.
2. Verify the effectiveness of CAPAs through follow-up audits or reviews.
3. Close out CAPAs once verified and ensure appropriate documentation.

4.6 Audit Follow-Up

1. Conduct follow-up audits as necessary to verify the sustained compliance and effectiveness of corrective actions.
2. Document and report on the status of follow-up actions and improvements.
3. Update the Annual Audit Schedule based on audit findings and priorities.

5) Abbreviations, if any

QA: Quality Assurance
SOP: Standard Operating Procedure
CAPA: Corrective and Preventive Actions

6) Documents, if any

Annual Audit Schedule, Audit Checklist, Audit Report, CAPA Documentation

7) Reference, if any

Regulatory guidelines such as FDA, EMA, ICH Q10 (Pharmaceutical Quality System), and ISO 19011 (Guidelines for Auditing Management Systems)

8) SOP Version

Version 1.0