SOP for Storing Excipients Based on Pharmacopoeial Guidelines – V 2.0

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SOP for Storing Excipients Based on Pharmacopoeial Guidelines – V 2.0

Standard Operating Procedure for Storing Excipients Based on Pharmacopoeial Guidelines

Department Warehouse / Quality Assurance
SOP No. SOP/RM/107/2025
Supersedes SOP/RM/107/2022
Page No. Page 1 of 15
Issue Date 07/02/2025
Effective Date 11/02/2025
Review Date 07/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the requirements for storing pharmaceutical excipients based on pharmacopoeial guidelines to maintain their quality, stability, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all excipients stored in the warehouse, including binders, fillers, disintegrants, lubricants, and preservatives. It covers storage conditions, environmental monitoring, and documentation procedures to ensure compliance with pharmacopeial standards (e.g., USP, BP, IP).

3. Responsibilities

  • Warehouse Personnel: Store excipients under specified conditions, monitor environmental parameters, and maintain accurate records.
  • Quality Assurance (QA): Verify compliance with pharmacopoeial storage requirements, conduct audits, and approve corrective actions in case of deviations.
  • Warehouse Manager: Ensure proper storage setup, functioning of monitoring equipment, and staff training on storage protocols.

4. Accountability

The Warehouse Manager is accountable for ensuring excipients are stored according to pharmacopoeial guidelines. The QA Manager is responsible for verifying compliance through inspections and audits.

5. Procedure

5.1 Storage Requirements Based on Pharmacopoeial Guidelines

  1. Temperature Control:
    • Store excipients at temperatures specified in pharmacopeial guidelines, typically between 15°C and 25°C, unless otherwise stated.
    • For excipients requiring refrigeration, maintain storage temperatures between 2°C and 8°C.
    • Document temperature readings in the Temperature Monitoring Log (Annexure-1).
  2. Humidity Control:
    • Maintain relative humidity below 60% unless specified differently for particular excipients.
    • Use desiccants for hygroscopic excipients and monitor humidity levels continuously.
    • Document humidity readings in the Humidity Monitoring Log (Annexure-2).
  3. Light Protection:
    • Store light-sensitive excipients in opaque containers or dark storage areas to prevent degradation.
    • Ensure storage areas have UV-protected lighting where necessary.
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5.2 Segregation and Labeling of Excipients

  1. Segregation by Type:
    • Segregate excipients based on their pharmacological properties (e.g., hygroscopic, temperature-sensitive).
    • Store excipients separately from APIs and hazardous materials to prevent cross-contamination.
  2. Labeling Requirements:
    • Ensure each container is labeled with:
      • Excipients Name
      • Batch/Lot Number
      • Manufacturer/Supplier Name
      • Manufacturing Date and Expiry Date
      • Storage Conditions (as per pharmacopeial guidelines)
    • Document labeling activities in the Labeling Log (Annexure-3).

5.3 Environmental Monitoring and Documentation

  1. Environmental Monitoring:
    • Continuously monitor temperature and humidity using calibrated equipment with alarm systems for deviations.
    • Perform manual checks daily and verify with automated monitoring data.
    • Document environmental data in the Environmental Monitoring Log (Annexure-4).
  2. Calibration of Monitoring Devices:
    • Calibrate all temperature and humidity monitoring devices at regular intervals, as specified by the manufacturer.
    • Record calibration activities in the Calibration Log (Annexure-5).

5.4 Handling of Deviations in Storage Conditions

  1. Deviation Detection:
    • If temperature or humidity deviates from the specified range, identify the cause and take immediate corrective action.
    • Document deviations in the Deviation Log (Annexure-6).
  2. Corrective Actions:
    • Move affected excipients to alternative storage conditions while resolving the issue.
    • QA will evaluate the impact on product quality and determine further actions.
    • Record corrective actions in the Corrective Action Log (Annexure-7).
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5.5 Periodic Review and Compliance Monitoring

  1. Warehouse Inspections:
    • Conduct regular inspections to ensure compliance with pharmacopoeial storage guidelines.
    • Document inspection findings in the Warehouse Inspection Log (Annexure-8).
  2. QA Compliance Audits:
    • QA will conduct periodic audits to verify excipients are stored according to pharmacopoeial standards.
    • Document audit findings in the Compliance Audit Log (Annexure-9).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • IP: Indian Pharmacopoeia
  • USP: United States Pharmacopeia
  • BP: British Pharmacopoeia

7. Documents

  1. Temperature Monitoring Log (Annexure-1)
  2. Humidity Monitoring Log (Annexure-2)
  3. Labeling Log (Annexure-3)
  4. Environmental Monitoring Log (Annexure-4)
  5. Calibration Log (Annexure-5)
  6. Deviation Log (Annexure-6)
  7. Corrective Action Log (Annexure-7)
  8. Warehouse Inspection Log (Annexure-8)
  9. Compliance Audit Log (Annexure-9)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
  • Indian Pharmacopoeia (IP) Guidelines
  • United States Pharmacopeia (USP) Guidelines
  • British Pharmacopoeia (BP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Temperature Monitoring Log

Date Storage Area Temperature (°C) Recorded By
07/02/2025 Excipient Storage Room A 22°C Ravi Kumar
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Annexure-2: Humidity Monitoring Log

Date Storage Area Humidity (%) Recorded By
07/02/2025 Excipient Storage Room A 45% Sunita Sharma

Annexure-3: Labeling Log

Date Excipient Name Batch Number Storage Condition Labeled By
07/02/2025 Lactose Monohydrate LM-2025-001 15°C – 25°C, Dry Anjali Mehta

Annexure-4: Environmental Monitoring Log

Date Storage Area Temperature (°C) Humidity (%) Recorded By
07/02/2025 Excipient Storage Room A 22°C 45% Ravi Kumar

Annexure-5: Calibration Log

Date Device Calibration Status Calibrated By
06/02/2025 Humidity Sensor 002 Calibrated Sunita Sharma

Annexure-6: Deviation Log

Date Deviation Action Taken Reported By
06/02/2025 Humidity exceeded 60% Activated additional dehumidifier Ravi Kumar

Annexure-7: Corrective Action Log

Date Issue Corrective Action Performed By
06/02/2025 Temperature deviation detected Adjusted HVAC settings Sunita Sharma

Annexure-8: Warehouse Inspection Log

Date Area Inspected Inspector Findings Corrective Actions
07/02/2025 Excipient Storage Room A Anjali Mehta No deviations detected N/A

Annexure-9: Compliance Audit Log

Date Audit Type Findings Corrective Actions Audited By
08/02/2025 Pharmacopoeial Compliance Audit All procedures 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
07/02/2025 2.0 Updated Storage Requirements and Documentation Formats Regulatory Compliance QA Head
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