Standard Operating Procedure for Checking Raw Material Storage Compliance During Audits
| Department | Quality Assurance / Warehouse |
|---|---|
| SOP No. | SOP/RM/166/2025 |
| Supersedes | SOP/RM/166/2022 |
| Page No. | Page 1 of 14 |
| Issue Date | 02/04/2025 |
| Effective Date | 09/04/2025 |
| Review Date | 02/04/2026 |
1. Purpose
This Standard Operating Procedure (SOP) defines the process for auditing raw material storage to ensure compliance with Good Manufacturing Practices (GMP) and regulatory standards. It provides guidelines for conducting audits, identifying non-compliance, and implementing corrective actions.
2. Scope
This SOP applies to all raw material storage areas, including warehouses, quarantine zones, and cold storage units. It covers the audit process for material storage practices, labeling, environmental controls, documentation, and handling procedures.
3. Responsibilities
- Quality Assurance (QA) Team: Conduct audits, document findings, and ensure corrective actions are implemented for any non-compliance identified during audits.
- Warehouse Supervisor: Facilitate the audit process, ensure records are available, and address any audit findings.
- Warehouse Personnel: Maintain compliance with storage procedures and assist during audits.
4. Accountability
The QA Manager is accountable for the execution of audits and ensuring compliance with storage standards. The Warehouse Manager is responsible for implementing corrective actions based on audit findings.
5. Procedure
5.1 Planning and Preparing for the Audit
- Audit Schedule:
- Develop an annual audit schedule covering all raw material storage areas.
- Communicate the audit schedule to all relevant departments at least one month in advance.
- Document the schedule in the Audit Schedule Log (Annexure-1).
- Preparation for the Audit:
- Review previous audit reports and corrective actions to identify recurring issues.
- Prepare an audit checklist covering all storage compliance aspects, including material handling, labeling, and environmental controls.
- Document preparation activities in the Audit Preparation Log (Annexure-2).
5.2 Conducting the Audit
- Audit Execution:
- Use the prepared checklist to systematically inspect raw material storage areas.
- Verify compliance with storage temperature, humidity controls, material segregation, and labeling requirements.
- Document findings in the Audit Findings Log (Annexure-3).
- Documentation Verification:
- Review storage records, including inventory logs, environmental monitoring logs, and labeling documentation.
- Ensure records are up-to-date, complete, and compliant with regulatory requirements.
- Document verification results in the Documentation Review Log (Annexure-4).
5.3 Identifying and Reporting Non-Conformities
- Non-Conformity Identification:
- Identify deviations from storage SOPs, such as improper labeling, environmental condition breaches, or inadequate segregation of materials.
- Classify non-conformities as minor, major, or critical based on potential impact on product quality.
- Document non-conformities in the Non-Conformity Report (Annexure-5).
- Reporting Non-Conformities:
- Communicate non-conformities to the Warehouse Manager and relevant personnel immediately after the audit.
- Prepare a formal audit report summarizing findings, non-conformities, and recommended corrective actions.
- Submit the report to the QA Manager for review and approval.
5.4 Implementing Corrective and Preventive Actions (CAPA)
- Corrective Actions:
- The Warehouse Manager must develop and implement corrective actions for identified non-conformities within the specified timeline.
- Ensure that corrective actions address the root cause of the non-conformity to prevent recurrence.
- Document corrective actions in the Corrective Action Log (Annexure-6).
- Preventive Actions:
- Implement preventive measures, such as training, process modifications, or equipment upgrades, to avoid future non-compliance.
- Document preventive actions in the Preventive Action Log (Annexure-7).
5.5 Follow-Up and Closure of Audits
- Verification of Corrective Actions:
- Conduct follow-up audits to verify the effectiveness of corrective actions.
- Ensure that all non-conformities are resolved before closing the audit.
- Document follow-up activities in the Audit Follow-Up Log (Annexure-8).
- Audit Closure:
- Prepare a final audit report summarizing the audit process, findings, corrective actions, and follow-up results.
- Submit the final report to the QA Manager for approval and archive it in the audit records.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- CAPA: Corrective and Preventive Action
7. Documents
- Audit Schedule Log (Annexure-1)
- Audit Preparation Log (Annexure-2)
- Audit Findings Log (Annexure-3)
- Documentation Review Log (Annexure-4)
- Non-Conformity Report (Annexure-5)
- Corrective Action Log (Annexure-6)
- Preventive Action Log (Annexure-7)
- Audit Follow-Up Log (Annexure-8)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- WHO Guidelines on Good Manufacturing Practices for Pharmaceutical Products
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
Annexure-1: Audit Schedule Log
| Date | Storage Area | Scheduled By | Audit Frequency |
|---|---|---|---|
| 02/04/2025 | Main Warehouse | QA Manager | Quarterly |
| 02/04/2025 | Cold Storage Unit | QA Manager | Monthly |
Annexure-2: Audit Preparation Log
| Date | Preparation Task | Completed By | Remarks |
|---|---|---|---|
| 01/04/2025 | Reviewed previous audit reports | Neha Verma | No critical findings |
| 01/04/2025 | Prepared audit checklist | Ravi Kumar | Checklist updated |
Annexure-3: Audit Findings Log
| Date | Finding Description | Severity | Auditor |
|---|---|---|---|
| 02/04/2025 | Improper labeling on two materials | Minor | Amit Joshi |
| 02/04/2025 | Temperature excursion in cold storage | Major | Priya Singh |
Annexure-4: Documentation Review Log
| Date | Document Reviewed | Findings | Reviewed By |
|---|---|---|---|
| 02/04/2025 | Environmental Monitoring Log | Complete, no discrepancies | Ravi Kumar |
| 02/04/2025 | Labeling Records | Missing label on one batch | Neha Verma |
Annexure-5: Non-Conformity Report
| Date | Non-Conformity | Severity | Reported By |
|---|---|---|---|
| 02/04/2025 | Temperature excursion in cold storage | Major | Priya Singh |
Annexure-6: Corrective Action Log
| Date | Non-Conformity | Corrective Action Taken | Performed By |
|---|---|---|---|
| 03/04/2025 | Temperature excursion | Recalibrated temperature sensors | Amit Joshi |
Annexure-7: Preventive Action Log
| Date | Preventive Action | Reason | Implemented By |
|---|---|---|---|
| 03/04/2025 | Installed backup cooling system | Prevent temperature excursions | Ravi Kumar |
Annexure-8: Audit Follow-Up Log
| Date | Follow-Up Finding | Resolved (Yes/No) | Verified By |
|---|---|---|---|
| 04/04/2025 | Temperature control issue | Yes | Neha Verma |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Implementation | QA Head |
| 02/04/2025 | 2.0 | Updated CAPA procedures | Enhanced Compliance Monitoring | QA Head |