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

1. Verify IMP received against invoice and Certificate of Analysis (CoA).
2. Store under recommended conditions (temperature, humidity) in the IMP storage area.
3. Log receipt in Annexure-1: IMP Receipt Log.

5.2 Pre-Dispensing Activities

1. Verify the study protocol, dosing schedule, and randomization list.
2. Generate individual dose labels including:
   • Study Code
   • Subject ID
   • Period & Sequence
   • IMP code (Test or Reference)
   • Date and time of dispensing
3. Prepare the required number of doses in dispensing area under clean conditions.

5.3 Dispensing of IMP

1. Pharmacist shall dispense the IMP based on randomization and in sealed containers.
2. Each dose pack must be:
   • Verified against the randomization list
   • Checked for expiry and appearance
3. Document in Annexure-2: IMP Dispensing Log with CRC counter-signature.

5.4 IMP Administration Support

1. CRC shall collect the IMP immediately before dosing from the dispensing window.
2. CRC confirms subject identity and ensures correct product is administered.
3. Record actual administration time in Annexure-3: IMP Dosing Record.

5.5 IMP Return and Reconciliation

1. Unused or returned IMP must be logged and returned to the pharmacist.
2. Complete Annexure-4: IMP Return and Reconciliation Log and reconcile against the issue record.

5.6 Labeling and Blinding

1. Ensure blinding (if applicable) is not compromised during label generation or dispensing.
2. Only unblinded pharmacist should have access to product code.

5.7 Deviations

1. 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

1. IMP Receipt Log – Annexure-1
2. IMP Dispensing Log – Annexure-2
3. IMP Dosing Record – Annexure-3
4. IMP Return and Reconciliation Log – Annexure-4
5. 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