SOP Guide for Pharma

SOP for Storage of Hygroscopic Raw Materials with Desiccants – V 2.0

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SOP for Storage of Hygroscopic Raw Materials with Desiccants – V 2.0

Standard Operating Procedure for Storage of Hygroscopic Raw Materials with Desiccants

Department Warehouse / Quality Assurance
SOP No. SOP/RM/110/2025
Supersedes SOP/RM/110/2022
Page No. Page 1 of 15
Issue Date 10/02/2025
Effective Date 14/02/2025
Review Date 10/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the procedures for the proper storage of hygroscopic raw materials using desiccants to prevent moisture absorption and ensure material integrity in compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all hygroscopic raw materials, including Active Pharmaceutical Ingredients (APIs), excipients, and chemicals that require moisture protection within the warehouse.

3. Responsibilities

4. Accountability

The Warehouse Manager is accountable for the proper storage of hygroscopic raw materials. The QA Manager is responsible for verifying compliance with regulatory requirements through inspections and audits.

5. Procedure

5.1 Identification and Classification of Hygroscopic Materials

  1. Material Identification:
    • Identify hygroscopic raw materials from supplier documentation such as the Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS).
    • Label materials as “Hygroscopic – Store with Desiccants” to ensure proper handling.
    • Document identification details in the Hygroscopic Material Identification Log (Annexure-1).
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5.2 Storage Requirements for Hygroscopic Materials

  1. Desiccant Usage:
    • Place appropriate desiccants (e.g., silica gel, molecular sieves) inside the packaging of hygroscopic materials.
    • Use sufficient desiccant quantity based on the material’s moisture sensitivity and storage volume.
    • Replace desiccants periodically as per manufacturer recommendations.
    • Document desiccant usage in the Desiccant Log (Annexure-2).
  2. Packaging and Sealing:
    • Ensure hygroscopic materials are stored in airtight, moisture-resistant containers (e.g., HDPE drums, foil-lined bags).
    • Seal containers tightly after each use to prevent moisture ingress.
    • Document sealing activities in the Packaging and Sealing Log (Annexure-3).

5.3 Environmental Monitoring and Documentation

  1. Humidity Control:
    • Store hygroscopic materials in controlled environments with relative humidity levels below 40%.
    • Use dehumidifiers in storage areas and monitor humidity levels continuously using calibrated devices.
    • Document humidity readings in the Humidity Monitoring Log (Annexure-4).
  2. Temperature Control:
    • Maintain storage temperatures as specified in the COA or MSDS, typically between 15°C and 25°C.
    • Monitor temperatures using calibrated thermometers and document readings in the Temperature Monitoring Log (Annexure-5).

5.4 Handling of Deviations in Storage Conditions

  1. Deviation Detection:
    • Identify deviations in humidity or temperature through continuous monitoring systems or manual checks.
    • Immediately isolate affected materials and assess potential quality impacts.
    • Document deviations in the Deviation Log (Annexure-6).
  2. Corrective Actions:
    • Transfer materials to alternative storage if required, and adjust environmental controls.
    • QA will evaluate the material’s integrity and determine further actions.
    • Document corrective actions in the Corrective Action Log (Annexure-7).

5.5 Desiccant Maintenance and Replacement

  1. Desiccant Monitoring:
    • Inspect desiccants regularly for signs of saturation (e.g., color changes in silica gel).
    • Replace desiccants as needed based on inspection results and manufacturer guidelines.
    • Document desiccant replacement activities in the Desiccant Replacement Log (Annexure-8).
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5.6 Periodic Review and Compliance Monitoring

  1. Warehouse Inspections:
    • Conduct periodic inspections to verify proper storage of hygroscopic materials and desiccant usage.
    • Document inspection findings in the Warehouse Inspection Log (Annexure-9).
  2. QA Compliance Audits:
    • QA will perform audits to ensure compliance with storage protocols for hygroscopic materials.
    • Document audit findings in the Compliance Audit Log (Annexure-10).

6. Abbreviations

7. Documents

  1. Hygroscopic Material Identification Log (Annexure-1)
  2. Desiccant Log (Annexure-2)
  3. Packaging and Sealing Log (Annexure-3)
  4. Humidity Monitoring Log (Annexure-4)
  5. Temperature Monitoring Log (Annexure-5)
  6. Deviation Log (Annexure-6)
  7. Corrective Action Log (Annexure-7)
  8. Desiccant Replacement Log (Annexure-8)
  9. Warehouse Inspection Log (Annexure-9)
  10. Compliance Audit Log (Annexure-10)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Hygroscopic Material Identification Log

Date Material Name Batch Number Storage Requirement Identified By
10/02/2025 Lactose Monohydrate LM-2025-001 Store with desiccants Ravi Kumar
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Annexure-2: Desiccant Log

Date Material Name Desiccant Type Quantity Used Added By
10/02/2025 Lactose Monohydrate Silica Gel 200g Sunita Sharma

Annexure-3: Packaging and Sealing Log

Date Material Name Container Type Sealed By
10/02/2025 Lactose Monohydrate HDPE Drum Anjali Mehta

Annexure-4: Humidity Monitoring Log

Date Storage Area Humidity (%) Recorded By
10/02/2025 Hygroscopic Storage Room 35% Ravi Kumar

Annexure-5: Temperature Monitoring Log

Date Storage Area Temperature (°C) Recorded By
10/02/2025 Hygroscopic Storage Room 22°C Sunita Sharma

Annexure-6: Deviation Log

Date Deviation Action Taken Reported By
09/02/2025 Humidity exceeded 40% Activated additional dehumidifier Ravi Kumar

Annexure-7: Corrective Action Log

Date Issue Corrective Action Performed By
09/02/2025 Humidity fluctuation detected Replaced faulty hygrometer Sunita Sharma

Annexure-8: Desiccant Replacement Log

Date Material Name Desiccant Type Replaced By
10/02/2025 Lactose Monohydrate Silica Gel Ravi Kumar

Annexure-9: Warehouse Inspection Log

Date Area Inspected Inspector Findings Corrective Actions
10/02/2025 Hygroscopic Storage Room Anjali Mehta No deviations found N/A

Annexure-10: Compliance Audit Log

Date Audit Type Findings Corrective Actions Audited By
11/02/2025 Hygroscopic Material Storage Compliance Audit Compliant N/A Anjali Mehta

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP QA Head
10/02/2025 2.0 Updated Storage Procedures and Documentation Formats Regulatory Compliance QA Head
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