Standard Operating Procedure for Labelling of Biological Samples in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/073/2025 |
| Supersedes | SOP/BA-BE/073/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To provide a standardized procedure for labelling biological samples, including blood and plasma, collected during Bioavailability/Bioequivalence (BA/BE) studies to ensure traceability, prevent mix-ups, and support regulatory compliance.
2. Scope
This SOP is applicable to all clinical and laboratory personnel responsible for primary and secondary labelling of biological samples (whole blood, plasma, serum) in BA/BE studies conducted at the clinical site or affiliated laboratories.
3. Responsibilities
- Phlebotomist: Performs initial labelling of collection tubes immediately after sample withdrawal.
- Lab Technician: Applies secondary labels on plasma aliquots post-centrifugation.
- CRC (Clinical Research Coordinator): Cross-verifies label content and ensures accuracy against subject ID and timepoint schedule.
4. Accountability
The Principal Investigator is accountable for ensuring proper labelling procedures are followed and any discrepancies are addressed prior to analysis or storage.
5. Procedure
5.1 Primary Labelling (Pre-Centrifugation)
- Label blood collection tubes before sample collection or immediately after using indelible, waterproof markers or pre-printed barcode labels.
- Each label must include:
- Subject ID (e.g., VOL-073)
- Period Number (e.g., P1, P2)
- Time Point (e.g., 2h)
- Date of Collection
- Example: VOL-073/P1/2h/17-04-2025
- Record this information in Annexure-1: Sample Label Verification Log.
5.2 Secondary Labelling (Post-Centrifugation)
- Transfer plasma to labelled cryovials using separate sterile pipettes for each subject.
- Secondary label must include:
- Same details as primary label
- Aliquot number (if applicable)
- Sample type (e.g., Plasma)
- Example: VOL-073/P1/2h/A1/Plasma
- Verify label before storing sample in -20°C or -70°C freezer as per protocol.
5.3 Barcode Labelling (If Applicable)
- Use validated barcode software integrated with study database.
- Scan barcode post-labelling and log confirmation in Annexure-2: Barcode Verification Log.
5.4 Cross-Verification of Labels
- CRC or QA personnel must:
- Verify 100% of labels for accuracy and legibility
- Confirm subject ID, timepoint, and sample type
- Document discrepancies and corrections in Annexure-3: Label Discrepancy Log.
5.5 Label Integrity and Storage
- Ensure labels are:
- Non-smudging, waterproof, and resistant to freezing temperatures
- Securely affixed and legible after centrifugation or storage
5.6 Deviation Management
- Label errors must be immediately corrected and signed off by the CRC and PI.
- Record in Annexure-3 and notify the QA unit for impact assessment.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- CRC: Clinical Research Coordinator
- PI: Principal Investigator
7. Documents
- Sample Label Verification Log – Annexure-1
- Barcode Verification Log (if applicable) – Annexure-2
- Label Discrepancy Log – Annexure-3
8. References
- ICH E6(R2) – Good Clinical Practice
- US FDA BA/BE Guidance
- Study Protocol and Lab Manual
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 Label Verification Log
| Subject ID | Timepoint | Label Checked By | Date | Remarks |
|---|---|---|---|---|
| VOL-073 | 2h | Sunita Reddy | 17/04/2025 | Correct |
Annexure-2: Barcode Verification Log
| Subject ID | Label Code | Scan Verified By | Date | Status |
|---|---|---|---|---|
| VOL-073 | BAR-073-P1-2H | R. Pawar | 17/04/2025 | Verified |
Annexure-3: Label Discrepancy Log
| Subject ID | Error Noted | Correction | Corrected By | Reviewed By |
|---|---|---|---|---|
| VOL-073X | Timepoint missing | Added 2h | Nisha Verma | Dr. Arvind Shah |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 12/01/2022 | 1.0 | Initial release | Process standardization | QA Head |
| 17/04/2025 | 2.0 | Added barcode process and discrepancy log | Audit compliance | QA Head |