SOP Guide for Pharma

SOP for Compliance with National and International Storage Guidelines – V 2.0

Auditor

SOP for Compliance with National and International Storage Guidelines – V 2.0

Standard Operating Procedure for Compliance with National and International Storage Guidelines

Department Warehouse / Quality Assurance / Regulatory Affairs
SOP No. SOP/RM/177/2025
Supersedes SOP/RM/177/2022
Page No. Page 1 of 15
Issue Date 12/04/2025
Effective Date 19/04/2025
Review Date 12/04/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for ensuring compliance with national and international storage guidelines for raw materials. This includes adherence to Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and country-specific regulatory requirements.

2. Scope

This SOP applies to all personnel in the Warehouse, Quality Assurance (QA), and Regulatory Affairs departments involved in the storage, inspection, and management of raw materials at the facility.

3. Responsibilities

  • Warehouse Personnel: Ensure that all storage activities comply with applicable regulations and maintain accurate documentation.
  • Quality Assurance (QA) Team: Conduct regular audits and inspections to verify compliance with storage guidelines.
  • Regulatory Affairs Team: Ensure alignment of internal procedures with national and international storage regulations.

4. Accountability

The QA Manager is accountable for verifying that storage practices comply with GMP and regulatory requirements. The Regulatory Affairs Manager is responsible for ensuring that the SOP reflects current regulatory standards.

5. Procedure

5.1 Identification of Applicable Guidelines

  1. Review of National and International Regulations:
    • Identify relevant guidelines such as GMP (21 CFR Part 211), WHO Good Storage Practices, and local FDA regulations.
    • Maintain a list of applicable regulations in the Regulatory Compliance Log (Annexure-1).
  2. Document Review and SOP Alignment:
    • Review all SOPs to ensure alignment with identified regulations.
    • Document the review process in the SOP Compliance Review Log (Annexure-2).
See also  SOP for Checking Raw Material Consignment for Transport Damages - V 2.0

5.2 Storage Conditions Compliance

  1. Temperature and Humidity Monitoring:
    • Ensure storage conditions meet regulatory requirements for temperature, humidity, and light exposure.
    • Log environmental conditions in the Environmental Monitoring Compliance Log (Annexure-3).
  2. Storage Area Validation:
    • Validate storage areas to confirm they meet national and international regulatory standards.
    • Record validation results in the Storage Area Validation Log (Annexure-4).

5.3 Documentation and Record-Keeping

  1. Maintaining Accurate Records:
    • Ensure all storage-related documentation is complete, accurate, and readily accessible for audits.
    • Track record-keeping compliance in the Document Control Compliance Log (Annexure-5).
  2. Audit Trail and Data Integrity:
    • Ensure data integrity in all storage-related records, maintaining clear audit trails.
    • Document data integrity audits in the Data Integrity Audit Log (Annexure-6).

5.4 Inspection, Audit, and Corrective Actions

  1. Routine Inspections:
    • Conduct weekly inspections to ensure compliance with national and international guidelines.
    • Record findings in the Inspection Compliance Log (Annexure-7).
  2. Audit and Corrective Actions:
    • Perform monthly audits and implement corrective actions for non-compliance.
    • Track corrective actions in the Corrective Action Compliance Log (Annexure-8).
See also  SOP for Use of Cold Storage Units for Sensitive Raw Materials - V 2.0

5.5 Training and Regulatory Updates

  1. Employee Training:
    • Conduct periodic training on regulatory compliance requirements.
    • Document training sessions in the Regulatory Compliance Training Log (Annexure-9).
  2. Regulatory Updates:
    • Ensure timely updates of SOPs following changes in national or international regulations.

6. Abbreviations

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

7. Documents

  1. Regulatory Compliance Log (Annexure-1)
  2. SOP Compliance Review Log (Annexure-2)
  3. Environmental Monitoring Compliance Log (Annexure-3)
  4. Storage Area Validation Log (Annexure-4)
  5. Document Control Compliance Log (Annexure-5)
  6. Data Integrity Audit Log (Annexure-6)
  7. Inspection Compliance Log (Annexure-7)
  8. Corrective Action Compliance Log (Annexure-8)
  9. Regulatory Compliance 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
  • ISO 9001:2015 Quality Management Systems Requirements

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Regulatory Compliance Log

Date Guideline/Regulation Applicable Area Reviewed By
12/04/2025 21 CFR Part 211 Warehouse Ravi Kumar

Annexure-2: SOP Compliance Review Log

Date SOP Title Compliance Status Reviewed By
12/04/2025 Storage of APIs Compliant Neha Verma
See also  SOP for Sampling at Receiving Stage for Preliminary Inspection - V 2.0

Annexure-3: Environmental Monitoring Compliance Log

Date Storage Area Temperature (°C) Humidity (%) Checked By
12/04/2025 Cold Storage 5°C 50% Amit Joshi

Annexure-4: Storage Area Validation Log

Date Storage Area Validation Status Validated By
12/04/2025 API Storage Validated Priya Singh

Annexure-5: Document Control Compliance Log

Date Document Title Control Status Checked By
12/04/2025 Raw Material Receiving Log Compliant Ajay Sharma

Annexure-6: Data Integrity Audit Log

Date Audit Area Findings Audited By
12/04/2025 Warehouse Records Compliant Kiran Patel

Annexure-7: Inspection Compliance Log

Date Inspection Area Compliance Status Inspected By
12/04/2025 Flammable Storage Compliant QA Supervisor

Annexure-8: Corrective Action Compliance Log

Date Non-Conformance Description Corrective Action Taken Verified By
12/04/2025 Humidity Exceeded Limit Adjusted Humidifiers QA Manager

Annexure-9: Regulatory Compliance Training Log

Date Employee Name Training Topic Trainer Remarks
12/04/2025 Sanjay Mehta National and International Storage Guidelines Regulatory Affairs 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
12/04/2025 2.0 Updated SOP to align with latest regulatory guidelines. Regulatory Update Regulatory Affairs Manager
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