BA-BE Studies: SOP for IMP Accountability Logs – V 2.0

Standard Operating Procedure for IMP Accountability Logs in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/081/2025
Supersedes	SOP/BA-BE/081/2022
Page No.	Page 1 of 10
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To establish a consistent and documented procedure for maintaining accurate Investigational Medicinal Product (IMP) accountability logs throughout the lifecycle of the IMP in Bioavailability/Bioequivalence (BA/BE) studies.

2. Scope

This SOP applies to all clinical and pharmacy staff responsible for receiving, storing, dispensing, reconciling, and returning or destroying IMPs in BA/BE studies at the study site.

3. Responsibilities

Pharmacist: Responsible for maintaining IMP receipt, dispensing, reconciliation, and return/destruction records.
Clinical Research Coordinator (CRC): Coordinates with the pharmacist to verify dispensing and return entries.
QA Officer: Periodically reviews IMP logs for completeness and accuracy.

4. Accountability

The Principal Investigator is accountable for the overall traceability and accountability of IMPs throughout the study as per regulatory and protocol requirements.

5. Procedure

5.1 IMP Receipt Logging

Upon receipt of IMP:
- Inspect packaging, quantity, and integrity
- Verify details against CoA and shipment documents
- Enter data into Annexure-1: IMP Receipt Log

5.2 IMP Storage Documentation

Store IMP under specified conditions (e.g., 15–25°C or refrigerated as applicable).
Log storage conditions and access details in Annexure-2: IMP Storage Log.

5.3 IMP Dispensing Record

Document dispensing activity in Annexure-3: IMP Dispensing Log including:
- Subject ID
- Period
- Product Code
- Quantity dispensed
- Date and time
- Dispensed by and received by signatures

5.4 IMP Reconciliation

Post-dosing, record unused, returned, or damaged IMPs in Annexure-4: IMP Reconciliation Log.
Reconcile total received, dispensed, returned, and balance stock at the end of each period.
Discrepancies must be investigated, documented, and signed off by QA and PI.

5.5 IMP Destruction or Return

IMP may be destroyed or returned as per sponsor’s instructions or protocol requirement.
Document disposal or return in Annexure-5: IMP Return/Destruction Log, along with witness signatures.

5.6 Log Review and Archival

All IMP accountability logs must be reviewed by QA for completeness at study close-out.
Logs should be archived as part of the Trial Master File (TMF) or eTMF.

6. Abbreviations

BA: Bioavailability
BE: Bioequivalence
IMP: Investigational Medicinal Product
QA: Quality Assurance
PI: Principal Investigator

7. Documents

IMP Receipt Log – Annexure-1
IMP Storage Log – Annexure-2
IMP Dispensing Log – Annexure-3
IMP Reconciliation Log – Annexure-4
IMP Return/Destruction Log – Annexure-5

8. References

ICH E6(R2) – Good Clinical Practice
Schedule Y – Drugs & Cosmetics Rules, India
21 CFR Part 312 – Investigational New Drug Application

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 Receipt Log

Date	IMP Code	Batch No.	Qty Received	Verified By	Remarks
16/04/2025	REF-081	R2201	100	R. Pawar	Intact

Annexure-2: IMP Storage Log

Date	IMP Code	Storage Temp (°C)	Location	Checked By
16/04/2025	REF-081	22°C	IMP Cabinet-1	Sunita Reddy

Annexure-3: IMP Dispensing Log

Subject ID	Period	IMP Code	Qty Dispensed	Dispensed By	CRC Sign
VOL-081	P1	REF-081	1	Sunita Reddy	Confirmed

Annexure-4: IMP Reconciliation Log

IMP Code	Qty Dispensed	Qty Returned	Qty Used	Balance	Verified By
REF-081	20	2	18	80	QA Team

Annexure-5: IMP Return/Destruction Log

Date	IMP Code	Action	Qty	Reason	Witnessed By
17/04/2025	REF-081	Destroyed	2	Expired	Dr. Arvind Shah

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
12/01/2022	1.0	Initial release	Procedure documentation	QA Head
17/04/2025	2.0	Expanded reconciliation and return records	GCP compliance	QA Head