type="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).

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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).

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.

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).

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

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