ensuring materials are inspected for moisture exposure during receipt. The QA Manager has the authority to approve or reject materials based on inspection findings. The Procurement Manager ensures suppliers follow appropriate packaging and shipping protocols to mitigate humidity exposure risks. The QC Manager oversees additional testing if humidity-related issues are detected.

5. Procedure

5.1 Pre-Receipt Preparations for High-Humidity Conditions

1. Supplier Communication:
   • Procurement must inform suppliers about the facility’s requirements for moisture-resistant packaging during high-humidity seasons.
   • Ensure suppliers provide documentation regarding moisture control measures (e.g., desiccants, moisture-barrier packaging).
2. Warehouse Preparation:
   • Ensure the receiving area is equipped with dehumidifiers and humidity monitors to maintain optimal conditions.
   • Prepare moisture detection tools (e.g., humidity indicators, moisture meters) for inspection.

5.2 Inspection of Materials Upon Arrival

1. Initial Visual Inspection:
   • Inspect packaging for signs of moisture damage, such as:
     • Condensation inside transparent packaging.
     • Warped, soft, or discolored boxes and containers.
     • Mold growth on external packaging.
   • Document initial inspection findings in the High-Humidity Material Receipt Log (Annexure-1).
2. Humidity Level Verification:
   • Measure the ambient humidity at the receiving area and record in the Humidity Monitoring Log (Annexure-2).
   • Use moisture meters to check for internal moisture exposure in packaging, especially for hygroscopic materials.

5.3 Handling and Storage of Materials in High-Humidity Conditions

1. Immediate Transfer to Controlled Storage:
   • Transfer sensitive materials to humidity-controlled storage areas immediately after inspection.
   • Use desiccants or silica gel packs inside storage areas where applicable.
   • Document storage conditions in the Controlled Storage Log (Annexure-3).

5.4 Handling Suspected Moisture Exposure

1. Identification of Moisture Damage:
   • If materials show signs of moisture exposure, segregate them and label as “UNDER REVIEW.”
   • Document moisture-related discrepancies in the Moisture Exposure Report (Annexure-4).
2. QA Review and Corrective Actions:
   • QA reviews reports and assesses the impact of moisture on material integrity.
   • QC conducts tests (e.g., water content analysis) to determine if the material is still within specifications.
   • Document corrective actions and final disposition in the Material Disposition Log (Annexure-5).

5.5 Supplier Communication and Resolution

1. Supplier Notification:
   • Procurement informs suppliers about moisture-related issues and requests corrective actions (e.g., improved packaging, alternative shipping methods).
   • Document supplier responses and corrective actions in the Corrective Action Log (Annexure-6).

6. Abbreviations

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

7. Documents

1. High-Humidity Material Receipt Log (Annexure-1)
2. Humidity Monitoring Log (Annexure-2)
3. Controlled Storage Log (Annexure-3)
4. Moisture Exposure Report (Annexure-4)
5. Material Disposition Log (Annexure-5)
6. Corrective Action Log (Annexure-6)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• EU Guidelines on Good Distribution Practices (GDP)

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: High-Humidity Material Receipt Log

Date	Material Name	Batch Number	Supplier Name	Packaging Condition	Received By	Remarks
01/02/2025	API-X	X-2025-001	PharmaChem Ltd.	No Visible Damage	Ravi Kumar	Compliant
01/02/2025	Excipient-Y	Y-2025-002	HealthSupplies Pvt. Ltd.	Packaging Softened	Sunita Sharma	Segregated for Review

Annexure-2: Humidity Monitoring Log

Date	Time	Location	Humidity Level (%)	Checked By
01/02/2025	10:00 AM	Receiving Dock	75%	Anjali Desai
01/02/2025	2:00 PM	Receiving Dock	80%	Ajay Singh

Annexure-3: Controlled Storage Log

Date	Material Name	Batch Number	Storage Location	Humidity Level (%)	Stored By
01/02/2025	API-X	X-2025-001	Humidity-Controlled Room 1	50%	Ramesh Patel

Annexure-4: Moisture Exposure Report

Date	Material Name	Batch Number	Observed Issue	Reported By	Status
01/02/2025	Excipient-Y	Y-2025-002	Softened Packaging	Sunita Sharma	Under QA Review

Annexure-5: Material Disposition Log

Date	Material Name	Batch Number	Disposition	Approved By	Remarks
02/02/2025	API-X	X-2025-001	Approved	Anjali Mehta	Meets Specifications
02/02/2025	Excipient-Y	Y-2025-002	Rejected	Anjali Mehta	Packaging Integrity Compromised

Annexure-6: Corrective Action Log

Date	Supplier Name	Material Name	Batch Number	Corrective Action Taken	Follow-Up Required
03/02/2025	HealthSupplies Pvt. Ltd.	Excipient-Y	Y-2025-002	Improved Moisture-Resistant Packaging Implemented	Yes

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Enhanced Procedures for High-Humidity Conditions	Improved Compliance	QA Head