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 |