SOP for Storage of APIs Under Controlled Conditions – V 2.0

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SOP for Storage of APIs Under Controlled Conditions – V 2.0

Standard Operating Procedure for Storage of APIs Under Controlled Conditions

Department Warehouse / Quality Assurance
SOP No. SOP/RM/106/2025
Supersedes SOP/RM/106/2022
Page No. Page 1 of 15
Issue Date 06/02/2025
Effective Date 10/02/2025
Review Date 06/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the storage requirements for Active Pharmaceutical Ingredients (APIs) under controlled conditions to ensure their stability, integrity, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all APIs stored in the warehouse that require controlled environmental conditions such as temperature, humidity, and light protection. It covers storage, monitoring, and documentation procedures.

3. Responsibilities

  • Warehouse Personnel: Ensure APIs are stored under the specified controlled conditions and maintain accurate records of environmental monitoring.
  • Quality Assurance (QA): Verify compliance with storage requirements, conduct periodic audits, and approve corrective actions if deviations occur.
  • Warehouse Manager: Oversee storage operations, ensure proper functioning of monitoring equipment, and address non-conformities.

4. Accountability

The Warehouse Manager is accountable for ensuring APIs are stored under controlled conditions. The QA Manager is responsible for verifying compliance through regular inspections and audits.

5. Procedure

5.1 Storage Requirements for APIs

  1. Temperature Control:
    • APIs must be stored within the temperature range specified by the manufacturer, typically between 15°C and 25°C unless otherwise stated.
    • Use temperature-controlled rooms or units equipped with continuous monitoring devices.
    • Document temperature readings in the Temperature Monitoring Log (Annexure-1).
  2. Humidity Control:
    • Maintain relative humidity below 60% or as specified by the manufacturer.
    • Dehumidifiers should be used in storage areas where required, and humidity levels must be continuously monitored.
    • Document humidity readings in the Humidity Monitoring Log (Annexure-2).
  3. Light Protection:
    • APIs sensitive to light should be stored in opaque containers or dark storage areas to prevent degradation.
    • Ensure that storage areas are equipped with UV-protected lighting where necessary.
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5.2 Storage Area Setup

  1. Designated Storage Areas:
    • APIs must be stored in designated, labeled storage areas with restricted access to authorized personnel only.
    • Segregate APIs based on their storage requirements and ensure proper labeling (Annexure-3).
  2. Shelving and Racking:
    • Use corrosion-resistant shelving and racking that allows for adequate airflow around the containers.
    • Ensure APIs are stored off the floor and away from walls to prevent contamination.

5.3 Monitoring and Documentation

  1. Environmental Monitoring:
    • Continuously monitor temperature and humidity using calibrated devices with alarms for deviations.
    • Perform manual checks daily and compare with automated system readings.
    • Record all environmental data in the Environmental Monitoring Log (Annexure-4).
  2. Calibration of Monitoring Equipment:
    • All monitoring equipment must be calibrated regularly according to the manufacturer’s recommendations.
    • Document calibration activities in the Calibration Log (Annexure-5).

5.4 Handling Deviations in Storage Conditions

  1. Deviation Detection:
    • If temperature or humidity deviates from the specified range, immediately investigate the cause and take corrective action.
    • Document all deviations in the Deviation Log (Annexure-6).
  2. Corrective Actions:
    • Move affected APIs to an alternative controlled environment until the issue is resolved.
    • QA must evaluate the potential impact on product quality and decide on further actions.
    • Document 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 verify compliance with storage conditions and procedures.
    • Record findings in the Warehouse Inspection Log (Annexure-8).
  2. QA Compliance Audits:
    • QA will conduct periodic audits to ensure all APIs are stored under the required controlled conditions.
    • Document audit findings in the Compliance Audit Log (Annexure-9).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • API: Active Pharmaceutical Ingredient

7. Documents

  1. Temperature Monitoring Log (Annexure-1)
  2. Humidity Monitoring Log (Annexure-2)
  3. Storage Area 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
  • WHO GMP 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
06/02/2025 API Storage Room 1 22°C Ravi Kumar
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Annexure-2: Humidity Monitoring Log

Date Storage Area Humidity (%) Recorded By
06/02/2025 API Storage Room 1 45% Sunita Sharma

Annexure-3: Storage Area Labeling Log

Date API Name Batch Number Storage Location Labeled By
06/02/2025 API-X API-X-2025-001 Shelf A1 Anjali Mehta

Annexure-4: Environmental Monitoring Log

Date Storage Area Temperature (°C) Humidity (%) Recorded By
06/02/2025 API Storage Room 1 22°C 45% Ravi Kumar

Annexure-5: Calibration Log

Date Device Calibration Status Calibrated By
05/02/2025 Temperature Sensor 001 Calibrated Sunita Sharma

Annexure-6: Deviation Log

Date Deviation Action Taken Reported By
05/02/2025 Temperature exceeded 25°C Moved APIs to backup storage Ravi Kumar

Annexure-7: Corrective Action Log

Date Issue Corrective Action Performed By
05/02/2025 Humidity exceeded 60% Repaired dehumidifier Sunita Sharma

Annexure-8: Warehouse Inspection Log

Date Area Inspected Inspector Findings Corrective Actions
06/02/2025 API Storage Room 1 Anjali Mehta All conditions within limits N/A

Annexure-9: Compliance Audit Log

Date Audit Type Findings Corrective Actions Audited By
07/02/2025 Storage Conditions 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
06/02/2025 2.0 Updated Storage Procedures and Documentation Formats Regulatory Compliance QA Head
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