Internal Audit Procedures in MDI Production

1) Purpose

The purpose of this SOP is to establish procedures for conducting internal audits in metered-dose inhaler (MDI) production to assess compliance with quality management systems, identify areas for improvement, and ensure adherence to regulatory requirements.

2) Scope

This SOP applies to all personnel involved in internal audit activities within the MDI production facility, including internal auditors, quality assurance managers, production supervisors, and regulatory affairs personnel.

3) Responsibilities

The responsibilities for this SOP include planning and conducting audits, documenting audit findings, and implementing corrective actions. Specific roles include:
Internal Auditors: Plan and execute internal audits according to audit schedules and procedures.
Quality Assurance Managers: Review audit findings, ensure corrective actions are implemented, and monitor audit effectiveness.
Production Supervisors: Provide access to production areas and assist auditors during audits.
Regulatory Affairs Personnel: Ensure audits comply with regulatory requirements and guidelines.

4) Procedure

4.1 Audit Planning
4.1.1 Develop audit plans based on risk assessment, regulatory requirements, and previous audit findings.
4.1.2 Define audit objectives, scope, and criteria for assessing compliance.
4.2 Audit Execution
4.2.1 Conduct opening meetings with auditees to explain audit objectives and procedures.
4.2.2 Perform on-site inspections, document reviews, and interviews with personnel.
4.3 Audit Findings
4.3.1 Document audit findings, including non-conformities, observations, and areas of improvement.
4.3.2 Classify audit findings based on severity and impact on compliance and product quality.
4.4 Corrective Actions
4.4.1 Communicate audit findings to relevant departments and initiate corrective actions.
4.4.2 Monitor implementation of corrective actions and verify effectiveness.
4.5 Audit Report and Follow-up
4.5.1 Prepare audit reports summarizing findings, conclusions, and recommendations.
4.5.2 Conduct follow-up audits to verify closure of audit findings and continuous improvement.

5) Abbreviations, if any

MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure

6) Documents, if any

Audit plans, audit reports, corrective action plans, and audit schedules should be maintained as part of the quality management system.

7) Reference, if any

Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for internal audit requirements in pharmaceutical manufacturing.

8) SOP Version

Version 1.0