Standard Operating Procedure for Label Generation and Sample Barcode Management in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/121/2025 |
| Supersedes | SOP/BA-BE/121/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To define the procedure for generating, assigning, and managing labels and barcodes for biological samples collected during Bioavailability/Bioequivalence (BA/BE) studies, ensuring sample traceability and data integrity.
2. Scope
This SOP applies to the Clinical and Bioanalytical staff involved in the preparation, identification, labeling, and tracking of plasma, blood, and other biological samples in BA/BE studies.
3. Responsibilities
- Label Coordinator: Prepares and verifies study-specific labels and barcodes before study initiation.
- Clinical Research Coordinator: Ensures correct labels are used at the time of sample collection.
- Bioanalytical Staff: Confirms barcode matches with sample ID before analysis or storage.
- QA Officer: Reviews label issuance logs and audits labeling process.
4. Accountability
The Head of Clinical Operations is accountable for ensuring that sample labeling and barcode management is conducted in accordance with protocol, GCP, and data integrity standards.
5. Procedure
5.1 Label Design and Structure
- Each sample label shall contain the following fields:
- Volunteer ID
- Study Code
- Sampling Time Point
- Period Number
- Sample Type (e.g., Plasma, Serum)
- Barcode (Code 128 or 2D)
- Standard format: [StudyCode]-[VolID]-[Period]-[Time]-[SampleType]
5.2 Label Generation
- Labels are generated using validated label printing software.
- Use Annexure-1: Label Generation Request Form to initiate request.
- Ensure printer calibration and alignment before label generation.
- Print labels in batches per subject, sorted by timepoint and period.
5.3 Label Verification and Documentation
- After printing:
- Randomly select 5% of labels for visual inspection.
- Verify field accuracy and barcode readability.
- Record verification in Annexure-2: Label Verification Log.
- Discard misprinted or damaged labels and log in Annexure-3: Label Rejection Log.
5.4 Label Application
- Labels must be applied:
- Before sample collection (preferred)
- Immediately post-collection if pre-labeling is not feasible
- Ensure labels are affixed straight and do not overlap on conical tubes or cryovials.
- Use gloves while handling labels to avoid contamination or smudging.
5.5 Barcode Tracking
- Scan barcodes during:
- Sample collection
- Centrifugation and aliquoting
- Storage and transport
- Link barcode scans to the Sample Tracking Log (Annexure-4).
5.6 Archival and Backup
- Maintain soft copies of label batches used in each study.
- Store printed label sheets (used and rejected) in a designated file.
- QA to archive logs and audit trails of barcode tracking systems.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- QA: Quality Assurance
- ID: Identification
- SOP: Standard Operating Procedure
7. Documents
- Label Generation Request Form – Annexure-1
- Label Verification Log – Annexure-2
- Label Rejection Log – Annexure-3
- Sample Tracking Log – Annexure-4
8. References
- ICH E6(R2) – Good Clinical Practice
- 21 CFR Part 11 – Electronic Records and Signatures
- WHO Guidelines for Clinical Sample Management
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Label Generation Request Form
| Date | Requested By | Study Code | No. of Subjects | Timepoints |
|---|---|---|---|---|
| 15/04/2025 | Rajesh Kumar | BE-121 | 24 | 0, 1, 2, 4, 8, 12 hrs |
Annexure-2: Label Verification Log
| Date | Batch No. | Verified By | No. Checked | Result |
|---|---|---|---|---|
| 16/04/2025 | LGL-BE121-01 | Sunita Reddy | 12 | Acceptable |
Annexure-3: Label Rejection Log
| Date | Label ID | Issue | Destroyed By |
|---|---|---|---|
| 16/04/2025 | BE121-V06-P1-0hr | Smudged print | Meena Joshi |
Annexure-4: Sample Tracking Log
| Date | Volunteer ID | Sample Type | Barcode | Location | Scanned By |
|---|---|---|---|---|---|
| 17/04/2025 | VOL-121-008 | Plasma | BE121-V08-P2-4hr | Freezer Rack B1 | Ajay Verma |
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 barcode scanning and tracking procedures | Inspection Recommendation | QA Head |