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

Warehouse Personnel: Ensure proper packaging, labeling, and handover of samples to QC personnel.
Quality Control (QC) Personnel: Verify receipt of samples, maintain sample integrity, and document transportation records.
Quality Assurance (QA): Monitor compliance with transportation protocols and approve deviations if they occur.

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.

5. Procedure

5.1 Preparation for Sample Transportation

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)
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

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.
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

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.
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).

5.4 Handling Deviations in Sample Transportation

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.
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

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).
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

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
QA: Quality Assurance
QC: Quality Control
PPE: Personal Protective Equipment

7. Documents

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