SOP Guide for Pharma

SOP for Sample Transportation from Quarantine Area to QC Lab – V 2.0

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SOP for Sample Transportation from Quarantine Area to QC Lab – V 2.0

Standard Operating Procedure for Sample Transportation from Quarantine Area to QC Lab

Department Quality Control / Quality Assurance / Warehouse
SOP No. SOP/RM/080/2025
Supersedes SOP/RM/080/2022
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 guidelines for safe, secure, and compliant transportation of raw material samples from the quarantine area to the Quality Control (QC) laboratory. It ensures the integrity of samples is maintained during transfer to support accurate testing and regulatory compliance.

2. Scope

This SOP applies to all raw material samples, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and temperature-sensitive materials, transported from the quarantine storage area to the QC laboratory for analysis.

3. Responsibilities

4. Accountability

The Warehouse Manager is responsible for the secure transfer of samples. The QC Manager ensures sample integrity during transportation, and the QA Manager oversees adherence to regulatory requirements.

See also  SOP for Chain of Custody Documentation for Sampled Quarantine Materials - V 2.0

5. Procedure

5.1 Preparation for Sample Transportation

  1. Sample Labeling:
    • Ensure all samples are labeled clearly with the following information:
      • Material Name
      • Batch/Lot Number
      • Sampled By (Name & Signature)
      • Date of Sampling
      • Storage Conditions (if applicable)
  2. Packaging:
    • Use tamper-proof, contamination-resistant containers for packaging samples.
    • For temperature-sensitive materials, use insulated boxes with ice packs or temperature loggers.
    • Ensure packaging materials comply with safety and material-specific requirements.

5.2 Transportation Procedure

  1. Handover Process:
    • Warehouse personnel must complete the Sample Handover Form (Annexure-1) before transferring the sample to QC personnel.
    • Both warehouse and QC personnel must sign the form to confirm handover.
  2. Sample Transfer:
    • Transport samples using designated carts or carriers that prevent physical damage or contamination.
    • For hazardous materials, ensure compliance with safety protocols, including appropriate PPE.
    • Temperature-sensitive materials must be transported within specified temperature ranges, monitored by data loggers if required.

5.3 Receipt and Verification in QC Lab

  1. Sample Verification:
    • Upon receipt, QC personnel must:
      • Verify the integrity of the sample packaging.
      • Confirm the sample label details match the Sample Handover Form.
      • Check temperature logs for compliance, if applicable.
  2. Documentation:
    • Record sample receipt details in the Sample Receipt Log (Annexure-2).
    • Report any discrepancies to the QA Manager and document them in the Sample Transportation Deviation Report (Annexure-3).

See also  SOP for Quarantine Procedures for Raw Materials Requiring Special Handling - V 2.0

5.4 Handling Deviations in Sample Transportation

  1. Deviation Reporting:
    • In case of temperature excursions, physical damage, or labeling errors, fill out the Sample Transportation Deviation Report (Annexure-3).
    • Notify the QA Manager immediately for further instructions.
  2. Corrective Actions:
    • Investigate the root cause of the deviation and implement corrective actions.
    • Document corrective measures in the Corrective Action Log (Annexure-4).

5.5 Training and Compliance

  1. Personnel Training:
    • All personnel involved in sample transportation must undergo training on proper handling, labeling, and documentation procedures.
    • Document training completion in the Training Log (Annexure-5).
  2. Compliance Monitoring:
    • QA must conduct periodic audits to ensure adherence to transportation protocols.
    • Document audit findings in the Compliance Audit Log (Annexure-6).

6. Abbreviations

7. Documents

  1. Sample Handover Form (Annexure-1)
  2. Sample Receipt Log (Annexure-2)
  3. Sample Transportation Deviation Report (Annexure-3)
  4. Corrective Action Log (Annexure-4)
  5. Training Log (Annexure-5)
  6. Compliance Audit Log (Annexure-6)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department
See also  SOP for Accepting and Handling of Herbal Raw Materials - V 2.0

11. Annexures

Annexure-1: Sample Handover Form

Date Material Name Batch Number Storage Condition Handed Over By (Warehouse) Received By (QC)
01/02/2025 API-X X-2025-001 25°C Ravi Kumar Sunita Sharma

Annexure-2: Sample Receipt Log

Date Material Name Batch Number Condition on Receipt Received By (QC) Verified By (QA)
01/02/2025 API-X X-2025-001 Intact, No Issues Sunita Sharma Anjali Mehta

Annexure-3: Sample Transportation Deviation Report

Date Material Name Batch Number Deviation Description Reported By
02/02/2025 API-X X-2025-001 Temperature Excursion (+2°C) Ajay Singh

Annexure-4: Corrective Action Log

Date Deviation Description Corrective Action Implemented By Verified By (QA)
03/02/2025 Temperature Excursion Calibrated Temperature Logger Ravi Kumar Anjali Mehta

Annexure-5: Training Log

Date Training Topic Trainer Attendee Name Signature
04/02/2025 Sample Transportation Procedures Health & Safety Officer Sunita Sharma

Annexure-6: Compliance Audit Log

Date Audit Type Findings Corrective Actions Taken Audited By
05/02/2025 Sample Transport Compliance Labeling Incomplete Revised Labeling Procedure 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
01/02/2025 2.0 Updated Sample Transportation Protocols Regulatory Compliance QA Head
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