SOP for Ensuring Compliance with FDA and WHO-GMP Storage Guidelines – V 2.0

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SOP for Ensuring Compliance with FDA and WHO-GMP Storage Guidelines – V 2.0

Standard Operating Procedure for Ensuring Compliance with FDA and WHO-GMP Storage Guidelines

Department Warehouse / Quality Assurance / Regulatory Affairs
SOP No. SOP/RM/187/2025
Supersedes SOP/RM/187/2022
Page No. Page 1 of 15
Issue Date 22/04/2025
Effective Date 29/04/2025
Review Date 22/04/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the processes and controls required to ensure compliance with FDA and WHO Good Manufacturing Practice (GMP) guidelines for the storage of raw materials in the warehouse.

2. Scope

This SOP applies to all warehouse activities related to the receipt, storage, handling, and monitoring of raw materials, including APIs, excipients, solvents, and hazardous substances, to ensure compliance with international regulatory standards.

3. Responsibilities

  • Warehouse Manager: Ensure all storage practices align with FDA and WHO-GMP guidelines.
  • Quality Assurance (QA) Team: Conduct routine inspections and audits to verify compliance with storage requirements.
  • Regulatory Affairs Team: Stay updated on changes in FDA and WHO guidelines and ensure SOP revisions reflect current regulations.

4. Accountability

The QA Manager is accountable for ensuring compliance with GMP storage guidelines, while the Warehouse Manager is responsible for implementing proper storage practices. The Regulatory Affairs Manager oversees the alignment of

SOPs with current regulatory requirements.

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5. Procedure

5.1 Storage Requirements and Environmental Monitoring

  1. Temperature and Humidity Control:
    • Maintain temperature and humidity within the specified ranges for each raw material type.
    • Document environmental monitoring in the Temperature and Humidity Log (Annexure-1).
  2. Storage Conditions for Specific Materials:
    • Ensure materials such as APIs, excipients, and solvents are stored under their respective conditions, including light protection, humidity control, and temperature regulation.
    • Record material-specific storage conditions in the Material Storage Conditions Log (Annexure-2).

5.2 Documentation and Record Keeping

  1. Maintaining Accurate Records:
    • Ensure all storage and handling records are accurate, complete, and compliant with data integrity requirements.
    • Document storage activities in the Storage Record Log (Annexure-3).
  2. Review and Approval of Records:
    • Conduct periodic reviews of storage records to ensure accuracy and regulatory compliance.
    • Document reviews in the Record Review Log (Annexure-4).

5.3 Compliance Audits and Inspections

  1. Internal Audits:
    • Conduct quarterly internal audits to assess compliance with FDA and WHO-GMP storage guidelines.
    • Document audit results in the Internal Audit Log (Annexure-5).
  2. Regulatory Inspections:
    • Prepare for regulatory inspections by maintaining readiness and ensuring all records are up to date.
    • Document inspection outcomes in the Regulatory Inspection Log (Annexure-6).

5.4 Handling Non-Conformances and CAPA

  1. Identifying Non-Conformances:
    • Immediately document and report any deviations from GMP storage guidelines.
    • Record non-conformances in the Non-Conformance Log (Annexure-7).
  2. Corrective and Preventive Actions (CAPA):
    • Implement CAPA measures for identified non-conformances and ensure timely resolution.
    • Document CAPA activities in the CAPA Log (Annexure-8).
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5.5 Training and Continuous Improvement

  1. Personnel Training:
    • Conduct regular training sessions on FDA and WHO-GMP storage guidelines for all relevant personnel.
    • Document training activities in the Training Log (Annexure-9).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • CAPA: Corrective and Preventive Actions
  • FDA: Food and Drug Administration
  • WHO: World Health Organization

7. Documents

  1. Temperature and Humidity Log (Annexure-1)
  2. Material Storage Conditions Log (Annexure-2)
  3. Storage Record Log (Annexure-3)
  4. Record Review Log (Annexure-4)
  5. Internal Audit Log (Annexure-5)
  6. Regulatory Inspection Log (Annexure-6)
  7. Non-Conformance Log (Annexure-7)
  8. CAPA Log (Annexure-8)
  9. Training Log (Annexure-9)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • WHO Good Storage Practices for Pharmaceuticals
  • FDA Guidance on Storage and Distribution of Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Temperature and Humidity Log

Date Storage Area Temperature (°C) Humidity (%) Checked By
22/04/2025 Cold Storage A 4°C 45% Ravi Kumar
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Annexure-2: Material Storage Conditions Log

Date Material Name Storage Condition Stored By
22/04/2025 API X Cool, Dry Place Neha Verma

Annexure-3: Storage Record Log

Date Material Name Batch Number Storage Location Recorded By
22/04/2025 Excipient Y EX-12345 Zone B Amit Joshi

Annexure-4: Record Review Log

Date Document Reviewed Reviewer Remarks
22/04/2025 Storage Record Log QA Supervisor Compliant

Annexure-5: Internal Audit Log

Date Audit Area Findings Audited By
22/04/2025 Cold Storage A No Issues Found QA Head

Annexure-6: Regulatory Inspection Log

Date Inspector Inspection Area Outcome
22/04/2025 FDA Inspector Raw Material Storage Compliant

Annexure-7: Non-Conformance Log

Date Non-Conformance Description Reported By Corrective Action Initiated
22/04/2025 Temperature Excursion in Cold Storage A Kiran Patel Adjusted HVAC System

Annexure-8: CAPA Log

Date CAPA Description Initiated By Status
22/04/2025 Installation of Backup Cooling System QA Manager Completed

Annexure-9: Training Log

Date Employee Name Training Topic Trainer Remarks
22/04/2025 Ravi Kumar FDA and WHO-GMP Storage Guidelines QA Manager Completed Successfully

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
22/04/2025 2.0 Updated to include CAPA and regulatory inspection procedures. Regulatory Update QA Head
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