Standard Operating Procedure for Conducting Internal Audits in Aerosol Production

1) Purpose

The purpose of this SOP is to establish a standardized procedure for conducting internal audits in aerosol production to ensure compliance with regulatory requirements, company policies, and quality standards. Internal audits help identify areas for improvement and ensure continuous quality enhancement.

2) Scope

This SOP applies to all departments involved in the production of aerosols at [Company Name]. It includes the planning, execution, documentation, and follow-up of internal audits.

3) Responsibilities

Internal Audit Team Leader: Plan and lead the internal audit process.
Internal Auditors: Conduct the audit as per the defined procedures and document findings.
Department Managers: Provide necessary information and assist auditors during the audit process.
Quality Assurance (QA) Manager: Review audit reports and ensure corrective actions are implemented.

4) Procedure

4.1 Audit Planning:
4.1.1 Develop an annual audit schedule covering all relevant areas of aerosol production.
4.1.2 Select audit team members with appropriate expertise and independence from the areas being audited.
4.1.3 Notify departments in advance about the audit schedule and scope.

4.2 Audit Preparation:
4.2.1 Review previous audit reports, SOPs, and regulatory requirements relevant to the audit scope.
4.2.2 Prepare an audit checklist based on key processes, compliance requirements, and areas of focus.

4.3 Conducting the Audit:
4.3.1 Hold an opening meeting with the auditee to explain the audit objectives, scope, and process.
4.3.2 Perform the audit by interviewing personnel, observing processes, and reviewing documentation.
4.3.3 Document all findings, including areas of compliance and non-compliance, with supporting evidence.

4.4 Audit Reporting:
4.4.1 Prepare an audit report summarizing the findings, including observations, non-conformances, and recommendations.
4.4.2 Hold a closing meeting with the auditee to discuss the audit findings and provide an opportunity for clarification.
4.4.3 Submit the audit report to the QA Manager and relevant department managers for review.

4.5 Corrective and Preventive Actions (CAPA):
4.5.1 Ensure that all non-conformances identified during the audit are documented in the CAPA system.
4.5.2 Collaborate with department managers to develop and implement corrective and preventive actions.
4.5.3 Monitor the implementation and effectiveness of CAPA and document follow-up activities.

4.6 Audit Follow-Up:
4.6.1 Conduct follow-up audits to verify that corrective actions have been implemented and are effective.
4.6.2 Update the audit schedule and scope based on the outcomes of previous audits and any new regulatory requirements.

5) Abbreviations, if any

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

6) Documents, if any

Audit Schedule
Audit Checklists
Audit Reports
CAPA Documentation
Previous Audit Reports

7) Reference, if any

GMP Guidelines
Internal Quality Policies
Regulatory Requirements (e.g., FDA, EMA)

8) SOP Version

Version 1.0