Standard Operating Procedure for Dispensing of Investigational Medicinal Product (IMP) in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/080/2025 |
| Supersedes | SOP/BA-BE/080/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To define a standardized procedure for the secure dispensing of the Investigational Medicinal Product (IMP) during Bioavailability/Bioequivalence (BA/BE) studies, ensuring traceability, subject safety, and regulatory compliance.
2. Scope
This SOP applies to all activities related to dispensing IMPs (test and reference products) to healthy volunteers enrolled in BA/BE studies conducted at the clinical research facility.
3. Responsibilities
- Pharmacist: Responsible for IMP receipt, storage, labeling, dispensing, and documentation.
- CRC: Coordinates dosing room activities and ensures IMP is administered as per randomization code.
- QA Officer: Verifies logs and audits IMP dispensing compliance.
4. Accountability
The Principal Investigator is accountable for ensuring that IMPs are dispensed only by authorized personnel and that all records are maintained in accordance with GCP and protocol requirements.
5. Procedure
5.1 Receipt and Storage of IMP
- Verify IMP received against invoice and Certificate of Analysis (CoA).
- Store under recommended conditions (temperature, humidity) in the IMP storage area.
- Log receipt in Annexure-1: IMP Receipt Log.
5.2 Pre-Dispensing Activities
- Verify the study protocol, dosing schedule, and randomization list.
- Generate individual dose labels including:
- Study Code
- Subject ID
- Period & Sequence
- IMP code (Test or Reference)
- Date and time of dispensing
- Prepare the required number of doses in dispensing area under clean conditions.
5.3 Dispensing of IMP
- Pharmacist shall dispense the IMP based on randomization and in sealed containers.
- Each dose pack must be:
- Verified against the randomization list
- Checked for expiry and appearance
- Document in Annexure-2: IMP Dispensing Log with CRC counter-signature.
5.4 IMP Administration Support
- CRC shall collect the IMP immediately before dosing from the dispensing window.
- CRC confirms subject identity and ensures correct product is administered.
- Record actual administration time in Annexure-3: IMP Dosing Record.
5.5 IMP Return and Reconciliation
- Unused or returned IMP must be logged and returned to the pharmacist.
- Complete Annexure-4: IMP Return and Reconciliation Log and reconcile against the issue record.
5.6 Labeling and Blinding
- Ensure blinding (if applicable) is not compromised during label generation or dispensing.
- Only unblinded pharmacist should have access to product code.
5.7 Deviations
- Document any deviations (e.g., wrong label, delayed dispensing) in Annexure-5: IMP Dispensing Deviation Log and inform QA.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- CRC: Clinical Research Coordinator
- CoA: Certificate of Analysis
- IMP: Investigational Medicinal Product
7. Documents
- IMP Receipt Log – Annexure-1
- IMP Dispensing Log – Annexure-2
- IMP Dosing Record – Annexure-3
- IMP Return and Reconciliation Log – Annexure-4
- IMP Dispensing Deviation Log – Annexure-5
8. References
- ICH E6(R2) – Good Clinical Practice
- Schedule Y – Indian Drugs and Cosmetics Rules
- Study Protocol and Randomization Scheme
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 | Product Code | Batch No. | Quantity | Storage Condition | Received By |
|---|---|---|---|---|---|
| 15/04/2025 | T-101 | B2302 | 120 Units | 25°C | R. Pawar |
Annexure-2: IMP Dispensing Log
| Subject ID | Period | IMP Code | Dispensed By | Date/Time | CRC Sign |
|---|---|---|---|---|---|
| VOL-080 | P1 | T-101 | Sunita Reddy | 17/04/2025 07:45 | Checked |
Annexure-3: IMP Dosing Record
| Subject ID | IMP Code | Dosing Time | Administered By | Remarks |
|---|---|---|---|---|
| VOL-080 | T-101 | 08:00 | Nisha Verma | On-Time |
Annexure-4: IMP Return and Reconciliation Log
| IMP Code | Returned Qty | Reason | Reconciled By | Date |
|---|---|---|---|---|
| T-101 | 2 | Unopened | QA Team | 17/04/2025 |
Annexure-5: IMP Dispensing Deviation Log
| Date | Subject ID | Deviation | Action Taken | Reviewed By |
|---|---|---|---|---|
| 17/04/2025 | VOL-080 | Label misprint | Replaced before dosing | Dr. Arvind Shah |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 15/01/2022 | 1.0 | Initial Release | Procedure definition | QA Head |
| 17/04/2025 | 2.0 | Expanded reconciliation and deviation handling | GCP Audit Requirement | QA Head |