contractual storage and transport conditions and address any discrepancies.

4. Accountability

The Warehouse Manager is responsible for the accurate verification of storage conditions upon receipt. The QA Manager holds authority to approve or reject materials based on compliance with storage requirements, while the Procurement Manager ensures supplier adherence to storage specifications. The QC Manager evaluates material quality if storage deviations are identified.

5. Procedure

5.1 Pre-Receipt Preparations

1. Supplier Requirements:
   • Procurement ensures suppliers provide detailed storage and transport conditions in the purchase agreement.
   • Suppliers must include temperature and humidity logs, if applicable, with each shipment.
2. Warehouse Preparations:
   • Warehouse personnel are trained on reviewing and documenting storage conditions upon receipt.
   • Ensure the availability of temperature and humidity monitoring equipment for on-site verification.

5.2 Verification of Storage Conditions at Receiving

1. Documentation Review:
   • Upon delivery, Warehouse personnel review the supplier-provided storage condition documentation, including:
     • Temperature and humidity logs.
     • Evidence of compliance with specified storage conditions during transit.
   • Record findings in the Storage Condition Verification Log (Annexure-1).
2. Inspection of Transport Conditions:
   • Inspect transportation equipment (e.g., refrigerated trucks, insulated containers) to ensure compliance with required conditions.
   • Use in-house temperature and humidity monitoring devices to verify real-time conditions.
   • Document results in the Transport Inspection Checklist (Annexure-2).

5.3 Handling Deviations in Storage Conditions

1. Identification of Deviations:
   • If storage conditions deviate from the specified range, segregate the materials and label them as “UNDER REVIEW.”
   • Document deviations in the Storage Condition Deviation Report (Annexure-3).
2. QA Review and Corrective Actions:
   • QA reviews deviation reports and determines the impact on material integrity.
   • If necessary, QC performs additional testing to confirm material quality.
   • Corrective actions and final disposition are recorded in the Material Disposition Log (Annexure-4).

5.4 Supplier Communication and Resolution

1. Supplier Notification:
   • Procurement contacts the supplier regarding storage condition deviations.
   • Request corrective actions, including improved packaging, transportation conditions, or material replacement.
2. Corrective Action Documentation:
   • Document the supplier’s corrective actions in the Corrective Action Log (Annexure-5).

6. Abbreviations

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

7. Documents

1. Storage Condition Verification Log (Annexure-1)
2. Transport Inspection Checklist (Annexure-2)
3. Storage Condition Deviation Report (Annexure-3)
4. Material Disposition Log (Annexure-4)
5. Corrective Action Log (Annexure-5)

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: Storage Condition Verification Log

Date	Material Name	Batch Number	Supplier Provided Temp (°C)	Required Temp (°C)	Humidity Level (%)	Verified By	Remarks
01/02/2025	API-X	X-2025-001	4°C	2-8°C	45%	John Doe	Within Limits
01/02/2025	Excipient-Y	Y-2025-002	15°C	10-15°C	60%	Jane Smith	Humidity Slightly Elevated

Annexure-2: Transport Inspection Checklist

Date	Material Name	Batch Number	Transport Condition	Packaging Integrity	Inspection Result	Inspected By
01/02/2025	API-X	X-2025-001	Refrigerated Truck	Intact	Pass	John Doe

Annexure-3: Storage Condition Deviation Report

Date	Material Name	Batch Number	Deviation Description	Impact on Material	Reported By	Status
02/02/2025	Excipient-Y	Y-2025-002	Humidity Above Limit	Potential Quality Impact	Jane Smith	Under Review

Annexure-4: Material Disposition Log

Date	Material Name	Batch Number	Disposition	Approved By	Remarks
03/02/2025	API-X	X-2025-001	Approved	QA Manager	Meets Specifications

Annexure-5: Corrective Action Log

Date	Supplier Name	Material Name	Batch Number	Corrective Action Taken	Follow-Up Required
03/02/2025	PharmaSuppliers Ltd.	Excipient-Y	Y-2025-002	Improved Packaging to Reduce Humidity Exposure	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	Added Transport Inspection Procedures	Standardization	QA Head