BA-BE Studies: SOP for IMP Destruction or Return Process – V 2.0

Standard Operating Procedure for IMP Destruction or Return Process in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/082/2025
Supersedes	SOP/BA-BE/082/2022
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 standard process for the destruction or return of Investigational Medicinal Products (IMPs) used in Bioavailability/Bioequivalence (BA/BE) studies, ensuring regulatory compliance and traceability of unused, damaged, or expired products.

2. Scope

This SOP applies to all clinical trial staff responsible for the handling, reconciliation, return, or destruction of IMPs at clinical research facilities conducting BA/BE studies.

3. Responsibilities

Pharmacist: Conducts IMP reconciliation, prepares documentation, and coordinates return or destruction.
Clinical Research Coordinator (CRC): Assists in verifying unused or damaged IMPs and logs the handover to pharmacy.
QA Officer: Reviews all destruction/return logs and ensures proper authorization.

4. Accountability

The Principal Investigator (PI) is accountable for ensuring that IMP returns or destruction are carried out per protocol, sponsor instructions, and applicable regulatory guidelines.

5. Procedure

5.1 Reconciliation of IMPs

Post-study or at the end of each study period, reconcile all dispensed IMPs using Annexure-1: IMP Reconciliation Log.
Classify the IMPs as:
- Used (administered)
- Unused (retained by subject or returned)
- Damaged (broken seal, expired, or compromised)

5.2 IMP Return Process

If the sponsor requests return of IMPs:
- Package and label IMPs as per sponsor’s shipping instructions.
- Prepare Annexure-2: IMP Return Log and obtain courier and sponsor acknowledgment.
- Include batch number, quantity, storage conditions, and reason for return.

5.3 IMP Destruction Process

If sponsor authorizes destruction:
- Prepare Annexure-3: IMP Destruction Log with:
  - IMP Code and batch number
  - Quantity
  - Reason for destruction
- Destruction must be witnessed by two staff members and QA.
- Follow local biomedical waste disposal rules for tablets, liquids, or injectables.

5.4 Documentation and Archival

All logs must be reviewed and signed by the PI and QA.
Maintain documents in the Trial Master File (TMF) or eTMF under the IMP section.

5.5 Deviations

Any unauthorized return, loss, or misplacement of IMP must be documented in Annexure-4: IMP Accountability Deviation Log and reported to the sponsor and regulatory authority if required.

6. Abbreviations

IMP: Investigational Medicinal Product
BA: Bioavailability
BE: Bioequivalence
CRC: Clinical Research Coordinator
PI: Principal Investigator
QA: Quality Assurance

7. Documents

IMP Reconciliation Log – Annexure-1
IMP Return Log – Annexure-2
IMP Destruction Log – Annexure-3
IMP Accountability Deviation Log – Annexure-4

8. References

ICH E6(R2) – Good Clinical Practice
Schedule Y – Drugs and Cosmetics Rules, India
WHO Guidelines for Disposal of Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: IMP Reconciliation Log

IMP Code	Batch No.	Qty Received	Dispensed	Returned	Balance	Remarks
TEST-082	B3001	100	85	10	5	5 Damaged

Annexure-2: IMP Return Log

Date	IMP Code	Batch No.	Qty Returned	Courier Details	Authorized By
18/04/2025	TEST-082	B3001	10	BlueDart AWB123456	Sunita Reddy

Annexure-3: IMP Destruction Log

Date	IMP Code	Qty Destroyed	Method	Witness 1	Witness 2
19/04/2025	TEST-082	5	Incineration	Ravi Nair	QA Officer

Annexure-4: IMP Accountability Deviation Log

Date	IMP Code	Deviation	Action Taken	Reported By	Reviewed By
17/04/2025	TEST-082	IMP missing 1 unit	Investigation initiated	Nisha Verma	Dr. Arvind Shah

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
12/01/2022	1.0	Initial Release	GCP Compliance	QA Head
17/04/2025	2.0	Inclusion of deviation tracking and improved annexures	Audit Preparedness	QA Head