SOP for Checking Compliance with Transportation and Delivery SOPs – V 2.0

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SOP for Checking Compliance with Transportation and Delivery SOPs – V 2.0

Standard Operating Procedure for Checking Compliance with Transportation and Delivery SOPs

Department Warehouse / Quality Assurance / Logistics / Procurement
SOP No. SOP/RM/037/2025
Supersedes SOP/RM/037/2022
Page No. Page 1 of 15
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for ensuring that all raw materials received at the facility comply with transportation and delivery requirements. Proper adherence to transportation SOPs is essential to maintain material integrity, ensure regulatory compliance, and uphold Good Distribution Practices (GDP). This SOP aims to:

  • Verify that raw materials are transported under specified conditions as per supplier agreements and regulatory requirements.
  • Ensure that transportation records, such as temperature logs and chain of custody documents, are accurate and complete.
  • Identify and address deviations in transportation conditions during the receipt of materials.
  • Maintain documentation to support compliance with Good Manufacturing Practices (GMP) and GDP guidelines.

2. Scope

This SOP applies to all raw materials received at the facility, covering the verification of compliance with transportation and delivery SOPs. It includes:

  • Procedures for checking transportation conditions, including temperature control, humidity, and handling requirements.
  • Review of transportation documents, including shipping manifests, temperature logs, and chain of custody 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.
See also  SOP for Unloading and Moving Raw Materials to the Quarantine Area - V 2.0

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).
See also  SOP for Verifying Vendor Compliance Before Accepting Raw Materials - V 2.0

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
See also  SOP for Handling Suspected Counterfeit or Adulterated Raw Materials - V 2.0

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.
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