records.

Identification and management of transportation deviations or non-compliance.

Roles and responsibilities of the Warehouse, Quality Assurance (QA), Logistics, and Procurement teams in verifying transportation compliance.

3. Responsibilities

• Warehouse Personnel:
  • Receive and inspect raw materials, ensuring compliance with specified transportation conditions.
  • Verify transportation documentation, including temperature logs and delivery records.
  • Record receipt details and any transportation deviations in the Raw Material Receiving Register (Annexure-1).
  • Report non-compliance with transportation SOPs to QA and Logistics immediately.
• Quality Assurance (QA) Team:
  • Review transportation documentation and verify compliance with GMP and GDP requirements.
  • Approve or reject materials based on transportation compliance and deviation assessments.
  • Coordinate with Logistics and Procurement for corrective actions in case of transportation non-compliance.
• Logistics Team:
  • Ensure that transportation providers comply with company transportation SOPs and regulatory requirements.
  • Provide the Warehouse and QA with transportation documentation prior to material receipt.
  • Address transportation-related deviations and coordinate with suppliers for corrective actions.
• Procurement Department:
  • Ensure that suppliers adhere to transportation requirements specified in purchase agreements.
  • Coordinate with Logistics to monitor transportation performance and address non-compliance issues.

4. Accountability

The Logistics Manager is responsible for ensuring that transportation providers comply with company SOPs and regulatory requirements. The Warehouse Manager is accountable for verifying that received materials meet transportation conditions. The QA Manager holds the authority to approve or reject materials based on transportation compliance and deviation assessments.

5. Procedure

5.1 Pre-Receipt Preparations

1. Review of Transportation and Delivery Requirements
   1. Logistics ensures that transportation providers are informed of the specified delivery conditions for raw materials, including:
      • Temperature and humidity requirements.
      • Handling and packaging instructions.
      • Chain of custody protocols for sensitive or controlled materials.
   2. Procurement ensures that transportation requirements are specified in purchase orders (POs) and supplier agreements.
2. Provision of Transportation Documentation
   1. Logistics provides the Warehouse and QA with transportation documentation prior to material receipt, including:
      • Shipping manifests and delivery notes.
      • Temperature logs or data logger reports.
      • Chain of custody records, if applicable.

5.2 Material Receipt and Verification

1. Verification of Transportation Conditions
   1. Warehouse personnel inspect the transportation conditions upon receipt, ensuring that:
      • Materials were transported under specified temperature and humidity conditions.
      • Packaging integrity is maintained, and no physical damage or tampering occurred during transit.
      • Temperature indicators, if provided, are within the acceptable range.
   2. Retrieve data from temperature loggers and review for any deviations from specified conditions.
2. Review of Transportation Documentation
   1. Warehouse personnel verify that transportation documentation is complete and accurate, including:
      • Shipping manifests match the received materials in terms of quantity and specifications.
      • Temperature logs indicate that materials were maintained within specified ranges during transit.
      • Chain of custody records are complete and signed, if applicable.
   2. Record all verification details in the Raw Material Receiving Register (Annexure-1).

5.3 Handling Transportation Deviations

1. Identification of Deviations
   1. If transportation deviations are identified (e.g., temperature excursions, damaged packaging):
      • Warehouse personnel immediately report the deviation to QA and Logistics.
      • Segregate and quarantine the affected materials pending further evaluation by QA.
2. QA Review and Corrective Actions
   1. QA reviews the transportation documentation and deviation reports to assess the impact on material integrity.
   2. If necessary, QC conducts testing to verify material quality after transportation deviations.
   3. Logistics coordinates with transportation providers and suppliers to address the root cause of deviations and implement corrective actions.

5.4 Final Disposition

1. Acceptance
   1. Materials that meet all transportation and delivery requirements are labeled “Accepted” and moved to the designated storage areas.
   2. Update the Raw Material Receiving Register to reflect the accepted status and ensure traceability.
2. Rejection
   1. Materials that fail to meet transportation requirements or show signs of compromised integrity are labeled “Rejected” and moved to the designated rejection area.
   2. Document the reason for rejection and initiate a non-conformance report.
3. Supplier and Transportation Provider Communication
   1. Procurement and Logistics communicate with suppliers and transportation providers to report deviations and coordinate corrective actions.
   2. Document all communications and update transportation SOPs if necessary to prevent recurrence.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• GDP: Good Distribution Practice
• QA: Quality Assurance
• QC: Quality Control
• PO: Purchase Order

7. Documents

1. Raw Material Receiving Register (Annexure-1)
2. Sampling Log (Annexure-2)
3. Shipping Manifests and Delivery Notes
4. Temperature Logs and Data Logger Reports
5. Chain of Custody Records (if applicable)
6. Non-Conformance Reports and Corrective Action Logs

8. References

• 21 CFR Part 211 – Current GMP for Finished Pharmaceuticals (US FDA)
• EU GDP Guidelines – Good Distribution Practice for Medicinal Products
• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• Company-Specific Logistics, QA, and Procurement Policies

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Raw Material Receiving Register

Date	Supplier Name	Material Name	Batch Number	PO Number	Quantity	Transportation Condition Compliance	Remarks
01/02/2025	ABC Chemicals	API-X	X-2025-001	PO-12345	100 kg	Compliant – Temp 2-8°C Maintained	Accepted
02/02/2025	XYZ Pharma	Excipient-Y	Y-2025-002	PO-67890	200 kg	Deviation – Temp Excursion to 12°C	Quarantined, Pending QA Review

Annexure-2: Sampling Log

Date	Material Name	Batch Number	Sampling Personnel	QC Test Performed	Result	Remarks
01/02/2025	API-X	X-2025-001	John Doe	Potency Test	Pass	Approved for Use
03/02/2025	Excipient-Y	Y-2025-002	Jane Smith	Purity Test	Pending	Awaiting QA Decision on Temperature Deviation

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head	All	All	Established procedures for verifying compliance with transportation and delivery SOPs.
01/02/2025	2.0	Added Transportation Deviation Handling	Standardization of Document	QA Head	All	All	Included detailed protocols for identifying and addressing transportation deviations.