Standard Operating Procedure for Quality Assurance Audits

1) Purpose

This SOP outlines the procedures for conducting quality assurance (QA) audits to ensure compliance with regulatory requirements and company standards, and to identify areas for continuous improvement.

2) Scope

This SOP applies to all internal and external QA audits conducted within the company, including audits of manufacturing processes, facilities, and quality management systems.

3) Responsibilities

The Quality Assurance (QA) department is responsible for planning, conducting, and reporting QA audits. The audited departments are responsible for cooperating with auditors and implementing corrective actions based on audit findings.

4) Procedure

4.1 Audit Planning

1. Develop an annual audit plan detailing the schedule, scope, and objectives of planned audits.
2. Identify the audit team members and assign responsibilities.
3. Prepare an audit checklist based on relevant SOPs, regulatory requirements, and previous audit findings.

4.2 Audit Execution

1. Conduct a pre-audit meeting with the audited department to discuss the audit scope, objectives, and schedule.
2. Review relevant documents and records, including SOPs, batch records, and quality control data.
3. Perform on-site inspections and interviews to assess compliance with SOPs and regulatory requirements.
4. Record all observations, findings, and evidence during the audit.

4.3 Audit Reporting

1. Prepare an audit report summarizing the findings, including areas of compliance and non-compliance.
2. Classify audit findings based on their severity (e.g., critical, major, minor).
3. Conduct a post-audit meeting with the audited department to discuss the findings and provide recommendations for corrective actions.

4.4 Corrective and Preventive Actions (CAPA)

1. Require the audited department to develop a corrective and preventive action (CAPA) plan addressing each audit finding.
2. Review and approve the CAPA plan to ensure it adequately addresses the audit findings.
3. Monitor the implementation of the CAPA plan and verify the effectiveness of corrective actions.

4.5 Follow-up and Closure

1. Schedule follow-up audits to verify the closure of audit findings and the effectiveness of implemented CAPAs.
2. Document the closure of audit findings and update the audit report accordingly.
3. Maintain all audit-related records in a secure and easily accessible manner.

5) Abbreviations, if any

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

6) Documents, if any

Audit Plans, Audit Checklists, Audit Reports, CAPA Plans, Follow-up Audit Reports

7) Reference, if any

Regulatory guidelines such as FDA, EMA, ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System)

8) SOP Version

Version 1.0