BA-BE Studies: SOP for Clinical Supply Label Review and Approval – V 2.0

Standard Operating Procedure for Clinical Supply Label Review and Approval in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/135/2025
Supersedes	SOP/BA-BE/135/2022
Page No.	Page 1 of 9
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To establish a uniform procedure for the review and approval of clinical supply labels for investigational and comparator products used in bioavailability/bioequivalence (BA/BE) studies, ensuring compliance with regulatory guidelines and trial protocols.

2. Scope

This SOP applies to all labeling activities related to clinical supplies including investigational product (IP), placebo, and reference drug packaging materials within the clinical and

logistics teams involved in BA/BE studies.

3. Responsibilities

Clinical Supplies Manager: Prepares draft label text and coordinates label creation.
Regulatory Affairs Representative: Reviews label for compliance with CDSCO/ICH labeling requirements.
Principal Investigator: Verifies that the label content aligns with protocol specifications.
Quality Assurance: Reviews final label proof and ensures documentation of approvals.

4. Accountability

The Head of Clinical Logistics is accountable for ensuring that no clinical material is dispensed or distributed without an approved, compliant label.

5. Procedure

5.1 Label Content Requirements

The clinical supply label must include:
- Protocol number
- Product name and strength (blinded where applicable)
- Dose instructions (e.g., “To be taken with food”)
- Storage conditions
- Batch/lot number
- Expiry date
- “For Clinical Trial Use Only” statement

5.2 Label Drafting and Review

Clinical Supplies Manager creates draft label using template in Annexure-1.
Submit label draft to:
- Regulatory Affairs for format and compliance check
- PI for protocol conformity
- QA for controlled document verification

5.3 Label Approval

All reviewers sign Annexure-2: Label Review and Approval Form.
Once approved, label artwork is locked and controlled under document ID.
Only the approved label version shall be printed and affixed to CTM.

5.4 Label Printing and Reconciliation

Label printing is executed by authorized personnel using validated printers.
Print quantity must match approved batch packaging log.
Use Annexure-3: Label Reconciliation Sheet to track label usage, destruction, and balance.

5.5 Storage and Documentation

Label copies and approval records are stored in the Trial Master File (TMF).
Retain records for a minimum of 5 years or as per regulatory requirement.

6. Abbreviations

BA: Bioavailability
BE: Bioequivalence
IP: Investigational Product
CTM: Clinical Trial Material
QA: Quality Assurance
TMF: Trial Master File

7. Documents

Label Template – Annexure-1
Label Review and Approval Form – Annexure-2
Label Reconciliation Sheet – Annexure-3

8. References

ICH E6(R2) – Good Clinical Practice
CDSCO Guidelines for Labeling of Investigational Products
Schedule Y – Drugs and Cosmetics Rules, India

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 Template

Field	Example
Protocol No.	BE-MET-001
Storage Condition	Store at 2–8°C
Label Text	For Clinical Trial Use Only

Annexure-2: Label Review and Approval Form

Reviewer	Role	Date	Comments	Signature
Rajesh Kumar	QA	16/04/2025	Compliant	Signed

Annexure-3: Label Reconciliation Sheet

Date	Batch	Labels Printed	Used	Destroyed	Balance
17/04/2025	B23MET01	250	200	50	0

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	Regulatory Compliance	QA Head
17/04/2025	2.0	Included reconciliation and digital record management	Audit Feedback	QA Head