SOP for Conducting Internal Audits for Aerosol Manufacturing
| Department | Aerosol |
|---|---|
| SOP No. | SOP/Aerosol/167/2025 |
| Supersedes | SOP/Aerosol/167/2022 |
| Page No. | Page 1 of Y |
| Issue Date | 06/02/2025 |
| Effective Date | 16/02/2025 |
| Review Date | 06/02/2028 |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the methodology for conducting internal audits in aerosol manufacturing facilities. Internal audits ensure compliance with Good Manufacturing Practices (GMP), identify process improvements, and mitigate risks associated with non-compliance.
2. Scope
This SOP applies to all departments involved in aerosol manufacturing, including Production, Quality Assurance (QA), Quality Control (QC), Engineering, and Regulatory Affairs. It covers audit planning, execution, reporting, and corrective action follow-ups.
3. Responsibilities
- Internal Audit Team: Responsible for planning and executing internal audits and ensuring adherence to regulatory guidelines.
- Quality Assurance (QA) Team: Responsible for reviewing audit reports and ensuring corrective actions are implemented.
- Department Heads: Responsible for addressing audit findings and implementing corrective and preventive actions (CAPA).
- Regulatory Affairs Team: Responsible for ensuring compliance with external regulatory requirements.
4. Accountability
The Quality Assurance (QA) Manager is accountable for ensuring internal audits are conducted as per this SOP and that necessary corrective actions are taken.
5. Procedure
5.1. Planning Internal Audits
- The Internal Audit Team develops an annual audit schedule covering all departments.
- Audits should be conducted quarterly, with additional audits scheduled in case
of non-compliance findings.
Audit scope, objectives, and criteria are defined in the Internal Audit Plan (Annexure-1).
5.2. Conducting Internal Audits
- Auditors should follow a checklist covering key GMP requirements, documentation, safety protocols, and equipment maintenance.
- Departments should provide access to all relevant records, including batch manufacturing records (BMRs), validation reports, and training logs.
- Observations, deviations, and best practices are documented in the Audit Findings Report (Annexure-2).
5.3. Identifying Non-Conformances
- Audit findings should be classified as:
- Critical: Potential impact on product safety, compliance violations.
- Major: Process deviations that could lead to non-compliance.
- Minor: Improvement areas that do not affect product quality.
- All non-conformances are documented in the Non-Conformance Report (Annexure-3).
5.4. Implementing Corrective and Preventive Actions (CAPA)
- Each department must submit a CAPA plan within 15 days of receiving the audit report.
- CAPA implementation is tracked in the CAPA Tracking Log (Annexure-4).
- Follow-up audits should be conducted to verify the effectiveness of corrective actions.
5.5. Closing the Audit
- Once all corrective actions are completed, the Internal Audit Team closes the audit findings.
- The final audit status is documented in the Internal Audit Closure Report (Annexure-5).
6. Abbreviations
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- QC: Quality Control
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- CAPA: Corrective and Preventive Action
7. Documents
- Internal Audit Plan (Annexure-1)
- Audit Findings Report (Annexure-2)
- Non-Conformance Report (Annexure-3)
- CAPA Tracking Log (Annexure-4)
- Internal Audit Closure Report (Annexure-5)
8. References
- Good Manufacturing Practice (GMP) Guidelines
- ISO 9001 – Quality Management Systems
- FDA Guidance on Internal Audits
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Internal Audit Plan
| Audit ID | Department | Audit Date | Lead Auditor | Scope |
|---|---|---|---|---|
| AUD-001 | Production | 06/02/2025 | Rajesh Patel | GMP Compliance |
Annexure-2: Audit Findings Report
| Finding ID | Category | Description | Risk Level | Action Plan |
|---|---|---|---|---|
| FND-001 | GMP Compliance | Incomplete batch records | Major | Training scheduled |
Annexure-3: Non-Conformance Report
| Non-Conformance ID | Description | Root Cause | Corrective Action |
|---|---|---|---|
| NC-001 | Improper equipment calibration | Missed calibration schedule | Updated calibration SOP |
12. Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | V 1.0 | Initial Release | First Issue | Anjali Sharma |
| 01/01/2025 | V 2.0 | Updated audit procedures | GMP Compliance | Anjali Sharma |