reuse of consumables.

Processing Technician: Handles only one subject’s samples at a time and disinfects work area between batches.

Quality Assurance (QA): Conducts periodic audits and reviews sample tracking logs for compliance.

Bioanalytical Staff: Verifies sample integrity upon receipt and inspects packaging for leaks or cross-labeling.

4. Accountability

The Head of Clinical Laboratory Operations is accountable for ensuring that all measures to prevent cross-contamination are in place, implemented, and periodically reviewed.

5. Procedure

5.1 General Laboratory Practices

1. All sample handling personnel must:
   • Wear gloves, masks, and lab coats at all times
   • Change gloves between subjects
   • Disinfect benchtops and centrifuges with 70% IPA before and after use

5.2 Sample Collection

1. Use pre-labeled, single-use vacutainers or blood collection tubes for each subject.
2. Maintain individual sample trays to avoid mixing of subject IDs.
3. Complete Annexure-1: Sample Collection Checklist for each subject at each timepoint.

5.3 Sample Processing

1. Process samples from one subject at a time.
2. Aliquot using separate, disposable pipette tips for each sample.
3. Ensure one operator handles both labeling and aliquoting to prevent misidentification.
4. Record processing times and personnel on Annexure-2: Sample Processing Log.

5.4 Storage and Segregation

1. Store samples in properly labeled cryoboxes, with:
   • Unique volunteer ID
   • Timepoint
   • Date
2. Do not mix samples from different studies in the same storage rack or freezer compartment.

5.5 Sample Transfer

1. Use sealed containers with absorbent materials for inter-department or site transfer.
2. Document chain of custody using Annexure-3: Sample Transfer Log.
3. Inspect each sample’s label upon receipt and verify against manifest.

5.6 Deviation Handling

1. Any suspicion or confirmed instance of contamination must be reported to QA immediately.
2. Initiate deviation report using Annexure-4: Contamination Incident Report.
3. Perform root cause analysis and implement CAPA.

6. Abbreviations

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

7. Documents

1. Sample Collection Checklist – Annexure-1
2. Sample Processing Log – Annexure-2
3. Sample Transfer Log – Annexure-3
4. Contamination Incident Report – Annexure-4

8. References

• ICH E6(R2) – Good Clinical Practice
• WHO Guidelines on Biological Sample Handling
• Schedule Y – Drugs and Cosmetics Rules

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 Collection Checklist

Volunteer ID	Timepoint	Tube Label Verified	Gloves Changed	Phlebotomist Signature
VOL-114-007	0 hr	Yes	Yes	Sunita Reddy

Annexure-2: Sample Processing Log

Volunteer ID	Start Time	End Time	Processed By	Remarks
VOL-114-007	10:00	10:12	Rajesh Kumar	None

Annexure-3: Sample Transfer Log

Date	Transferred By	Received By	Container ID	Status
17/04/2025	Ajay Verma	Meena Joshi	BOX-22	Intact

Annexure-4: Contamination Incident Report

Date	Volunteer ID	Description	Root Cause	CAPA
16/04/2025	VOL-114-005	Sample mixed with wrong label	Label not double-checked	Staff retraining, checklist revision

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
12/01/2022	1.0	Initial SOP	Regulatory Requirement	QA Head
17/04/2025	2.0	Added checklist annexures and clarified glove and pipette usage	Audit Findings	QA Head