Standard Operating Procedure for Conducting Internal GMP Audits and Corrective Actions
1) Purpose
This SOP outlines the procedures for conducting internal GMP audits and implementing corrective actions to ensure compliance with Good Manufacturing Practices and regulatory requirements.
2) Scope
This SOP applies to all departments and personnel involved in GMP-regulated activities at [Company Name].
3) Responsibilities
- Internal Audit Team: Conducts scheduled GMP audits of production, quality control, and documentation activities.
- Department Supervisors: Ensure that their respective areas are prepared for audits and that corrective actions are implemented as required.
- Quality Assurance (QA): Reviews audit findings and verifies the effectiveness of corrective actions.
4) Procedure
4.1 Planning the Audit
4.1.1 Developing the Audit Schedule
- Develop an annual audit schedule, with at least one internal GMP audit conducted per department per year. Prioritize critical areas based on risk assessments and past audit findings.
- Distribute the audit schedule to department heads and ensure that adequate resources are allocated for the audit process.
4.1.2 Preparing for the Audit
- Audit teams must prepare an audit checklist specific to the area being audited. The checklist should include key areas such as production processes, quality control, documentation, and personnel training.
- Ensure that all relevant SOPs, batch records, and logs are available for review during the audit.
4.2 Conducting the Audit
4.2.1 Performing the Audit
- During the
audit, review all processes, records, and practices to ensure compliance with GMP standards. Inspect production areas, equipment, and documentation for adherence to procedures.
Interview personnel to assess their understanding of GMP principles and their roles in ensuring compliance. Document all observations and findings in the audit report.
4.2.2 Identifying Non-Conformances
- If any non-conformances are identified during the audit, document them in the audit report and classify them based on their severity (e.g., minor, major, critical).
- Discuss findings with the department supervisor and ensure that corrective actions are proposed to address the non-conformances.
4.3 Post-Audit Activities
4.3.1 Preparing the Audit Report
- Compile all audit findings and corrective actions into an audit report. Include a summary of the areas audited, non-conformances identified, corrective actions required, and timelines for implementation.
- Submit the audit report to QA for review and approval.
4.3.2 Implementing Corrective Actions
- Department supervisors must implement corrective actions within the specified timeline and document the completion of these actions in the corrective action log.
- QA will verify the effectiveness of the corrective actions through follow-up audits or inspections.
5) Abbreviations, if any
- GMP: Good Manufacturing Practices
- QA: Quality Assurance
6) Documents, if any
- Audit Report
- Corrective Action Log
7) References, if any
- Internal SOP for corrective actions
8) SOP Version
Version 1.0
Annexure
1. Audit Report Template
| Audit Date | Area Audited | Findings | Severity (Minor/Major/Critical) | Corrective Actions | Due Date | QA Approval |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Department Name | Description of Findings | Severity of Findings | Proposed Corrective Actions | Deadline for Completion | QA Name |