SOP Guide for Pharma

SOP for Checking Raw Material Storage Compliance During Audits – V 2.0

Auditor

SOP for Checking Raw Material Storage Compliance During Audits – V 2.0

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

  1. 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).
  2. 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).
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5.2 Conducting the Audit

  1. 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).
  2. 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

  1. 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).
  2. 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)

  1. 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).
  2. 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).
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5.5 Follow-Up and Closure of Audits

  1. 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).
  2. 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

  1. Audit Schedule Log (Annexure-1)
  2. Audit Preparation Log (Annexure-2)
  3. Audit Findings Log (Annexure-3)
  4. Documentation Review Log (Annexure-4)
  5. Non-Conformity Report (Annexure-5)
  6. Corrective Action Log (Annexure-6)
  7. Preventive Action Log (Annexure-7)
  8. 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
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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
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