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).

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).

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

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• COA: Certificate of Analysis
• MSDS: Material Safety Data Sheet

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

• 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: 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

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