satellite collection clinics to the main analytical facility.

3. Responsibilities

• Satellite Clinic Coordinator: Ensures proper labeling, packaging, and documentation prior to dispatch.
• Courier/Transport Personnel: Transfers the samples in validated transport containers maintaining cold chain.
• Central Lab Receiver: Verifies receipt, condition, temperature status, and signs chain of custody log.
• QA Officer: Reviews transport records and investigates any deviations.

4. Accountability

The Clinical Operations Manager and Laboratory Head are accountable for ensuring compliant and traceable transport of samples from satellite clinics to the central storage or processing site.

5. Procedure

5.1 Pre-Shipment Preparation

1. Use Annexure-1: Sample Dispatch Checklist to verify correct labeling, primary packaging, and number of samples.
2. Place labeled tubes in leak-proof, pre-chilled secondary containers with absorbent material.
3. Pack into validated tertiary containers with gel packs/dry ice as per required temperature (-20°C or -70°C).

5.2 Documentation

1. Complete the following before dispatch:
   • Annexure-2: Sample Transfer Manifest
   • Annexure-3: Chain of Custody Log
   • Attach copy of Sample Reconciliation Sheet
2. Seal tertiary container with tamper-evident tape.

5.3 Transport and Monitoring

1. Use validated courier with cold chain logistics experience.
2. Affix “Biological Samples – Handle with Care” and temperature requirement label.
3. Place a temperature monitoring device inside each shipment (Annexure-4: Temperature Logger Report).

5.4 Receipt at Central Lab

1. On receipt:
   • Inspect container integrity
   • Verify temperature range compliance
   • Cross-check manifest and actual samples
2. Document findings in Annexure-5: Sample Receipt Form.

5.5 Deviations and CAPA

1. If temperature excursions or tampering is observed:
   • Segregate affected samples
   • Document in deviation form (Annexure-6)
   • Initiate CAPA in coordination with QA

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action

7. Documents

1. Sample Dispatch Checklist – Annexure-1
2. Sample Transfer Manifest – Annexure-2
3. Chain of Custody Log – Annexure-3
4. Temperature Logger Report – Annexure-4
5. Sample Receipt Form – Annexure-5
6. Deviation Form and CAPA Log – Annexure-6

8. References

• ICH E6(R2) – Good Clinical Practice
• Schedule Y – Drugs and Cosmetics Rules
• WHO Technical Report Series on Sample Transport

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 Dispatch Checklist

Item	Status	Remarks
Labels verified	Yes	Confirmed
Temperature packs	Yes	Frozen

Annexure-2: Sample Transfer Manifest

Volunteer ID	Timepoint	Tube Count	Volume
VOL-113-008	2hr	2	2.5 mL each

Annexure-3: Chain of Custody Log

Date	From	To	Signature	Remarks
17/04/2025	Satellite Clinic A	Central Lab	Signed	Frozen condition maintained

Annexure-4: Temperature Logger Report

Attached PDF generated by TempSure Logger. Range: -21.2°C to -23.5°C

Annexure-5: Sample Receipt Form

Received By	Date	Condition	Temperature	Remarks
Ajay Verma	17/04/2025	Good	-22.5°C	All samples intact

Annexure-6: Deviation Form and CAPA Log

Date	Deviation	Root Cause	CAPA	Closed By
16/04/2025	Temperature logger not activated	Human error	Retraining of site staff	QA Head

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/01/2022	1.0	Initial SOP Release	GCP Compliance	QA Head
17/04/2025	2.0	Added chain of custody and validated packaging protocols	Logistics Audit	QA Head