Standard Operating Procedure for Labeling and Identification of Analytical Batches in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/169/2025
Supersedes	SOP/BA-BE/169/2022
Page No.	Page 1 of 9
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To define a standard procedure for the labeling and unique identification of analytical batches in bioanalytical studies supporting BA/BE clinical trials to ensure traceability, prevent sample mix-ups, and comply with regulatory standards.

2. Scope

This SOP is applicable to all analysts and supervisors involved in labeling, identifying, and documenting analytical batches prepared for LC-MS/MS analysis of plasma samples in BA/BE studies.

3. Responsibilities

• Analyst: Prepares and labels analytical batches as per SOP guidelines and logs them in batch identification records.
• Supervisor: Reviews and verifies correctness of labels and documentation.
• QA: Performs periodic audits to ensure compliance with labeling conventions and traceability standards.

4. Accountability

The Bioanalytical Laboratory Manager is accountable for the implementation of consistent labeling formats and batch identification systems to support GLP and GCP practices.

5. Procedure

5.1 Batch Numbering Convention

1. Each analytical batch shall be assigned a unique ID following the format:
   • Format: [StudyCode]-[AnalyteCode]-[BatchNumber]
   • Example: BE1234-MET-01
2. The batch number shall be sequential and reset for each new analyte in the same study.
3. Document all batch numbers in Annexure-1: Analytical Batch Identification Log.

5.2 Labeling of Vials and Trays

1. All vials (calibrators, QCs, and samples) shall be labeled with:
   • Study Code
   • Sample ID
   • Batch ID
   • Vial position (e.g., B5)
2. Trays must also carry tray number, run ID, and analyst initials.
3. Use tamper-evident and water-resistant printed barcode labels wherever applicable.

5.3 Sequence File Naming and Metadata

1. Each instrument sequence file shall be named according to:
   • [StudyCode]_Seq_[BatchNumber]_YYYYMMDD
   • Example: BE1234_Seq_01_20250417
2. Save sequence files in a structured folder system with study-wise and batch-wise segregation.

5.4 Label Verification and Documentation

1. After labeling, a second analyst or supervisor must cross-verify the labels and sign in Annexure-2: Label Verification Checklist.
2. Any corrections must be made before sample loading into the autosampler tray.

5.5 Deviations and Corrections

1. In case of incorrect labeling:
   • Segregate affected vials immediately
   • Replace labels using reprint procedure and document in Annexure-3: Labeling Deviation Log
2. Cross-check sample IDs with CRF and sample receipt log before correction.

6. Abbreviations

• BA/BE: Bioavailability/Bioequivalence
• QC: Quality Control
• CRF: Case Record Form
• GLP: Good Laboratory Practice
• GCP: Good Clinical Practice

7. Documents

1. Analytical Batch Identification Log – Annexure-1
2. Label Verification Checklist – Annexure-2
3. Labeling Deviation Log – Annexure-3

8. References

• ICH M10: Bioanalytical Method Validation
• FDA Bioanalytical Method Validation Guidance
• Internal Labeling SOP Policy

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Analytical Batch Identification Log

Batch ID	Study Code	Analyte	Date Created	Prepared By
BE1234-MET-01	BE1234	Metformin	17/04/2025	Sunita Reddy

Annexure-2: Label Verification Checklist

Sample ID	Label Content Verified	Initials	Date
BE101-TP3	Yes	RK	17/04/2025

Annexure-3: Labeling Deviation Log

Date	Sample ID	Issue	Corrective Action	Verified By
17/04/2025	BE101-TP5	Missing Vial Position	Reprinted label and updated log	QA Officer

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	New SOP	QA Head
17/04/2025	2.0	Inclusion of barcode labels and deviation log	Compliance update	QA Head