BA-BE Studies: SOP for Supervision of Dosing Procedures – V 2.0

Standard Operating Procedure for Supervision of Dosing Procedures in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/063/2025
Supersedes	SOP/BA-BE/063/2022
Page No.	Page 1 of 10
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To describe the procedure for the supervision of dosing in BA/BE studies to ensure that investigational products are administered accurately and safely, in accordance with the study protocol, GCP guidelines, and regulatory requirements.

2. Scope

This SOP applies to all study personnel involved in the supervision and administration of the investigational product during the dosing phase of a BA/BE clinical trial.

3. Responsibilities

Principal Investigator/Sub-Investigator: Responsible for oversight and verification of subject identity, dosing accuracy, and adherence to protocol.
Dosing Nurse: Administers the study drug under supervision and records dosing details.
Clinical Research Coordinator: Coordinates subject flow and ensures appropriate documentation and adherence to scheduled dosing time.

4. Accountability

The Principal Investigator is accountable for ensuring that the dosing process is conducted safely and in strict compliance with the protocol and regulatory standards.

5. Procedure

5.1 Pre-Dosing Verification

Verify the subject’s identity using two identifiers (Subject ID and Government-issued ID).
Confirm subject eligibility based on pre-dose assessments (e.g., physical exam, lab tests, ECG).
Ensure completion of informed consent and fasting compliance (if applicable).

5.2 Study Drug Preparation

Confirm the correct formulation, dose, and code as per the randomization schedule.
Check drug label details, expiration date, and batch number.
Document details in Annexure-1: Dosing Preparation Log.

5.3 Dosing Room Setup

Ensure that water volume (typically 240 mL) and necessary safety measures are in place.
Prepare the environment for subject comfort and ensure monitoring equipment is functional.

5.4 Dosing Execution

Administer the investigational product to the subject within the scheduled time window.
Confirm complete ingestion of the drug and water.
Record dosing time, water volume, and initials of staff involved in Annexure-2: Dosing Record Sheet.

5.5 Post-Dose Monitoring and Documentation

Monitor subjects for at least 2 hours post dosing for any immediate adverse events.
Document observations in the subject’s CRF and Annexure-3: Post-Dose Observation Log.

5.6 Deviation Management

If any dosing error or deviation occurs, notify the PI immediately.
Document details in Annexure-4: Dosing Deviation Log and initiate protocol deviation documentation as applicable.

6. Abbreviations

BA: Bioavailability
BE: Bioequivalence
PI: Principal Investigator
CRF: Case Report Form

7. Documents

Dosing Preparation Log – Annexure-1
Dosing Record Sheet – Annexure-2
Post-Dose Observation Log – Annexure-3
Dosing Deviation Log – Annexure-4

8. References

ICH E6(R2) – Good Clinical Practice
CDSCO Guidelines for BA/BE Studies
Study Protocol

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Dosing Preparation Log

Date	Subject ID	IP Code	Batch No.	Prepared By
17/04/2025	VOL-063	TEST-A	B-0325	Rahul Patil

Annexure-2: Dosing Record Sheet

Subject ID	Dosing Time	Water Volume	Dosed By	Remarks
VOL-063	07:00	240 mL	Dr. Sunita Reddy	No issues

Annexure-3: Post-Dose Observation Log

Subject ID	Time Interval	Vitals Checked	AE Observed	Initials
VOL-063	0–2 hrs	Yes	No	R. Pawar

Annexure-4: Dosing Deviation Log

Subject ID	Deviation	Time	Action Taken	Investigator
VOL-063X	Dosed 6 mins late	07:06	Included; documented deviation	Dr. Arvind Shah

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
12/01/2022	1.0	Initial Release	New SOP	QA Head
17/04/2025	2.0	Added annexures, clarified roles	Audit requirement	QA Head