3. Responsibilities

• Pharmacist-in-Charge: Ensures accurate logging and verification of received CTM.
• Site Coordinator: Assists in physical inspection and documentation during CTM receipt.
• Principal Investigator (PI): Verifies CTM receipt records and ensures proper storage.
• QA Officer: Audits receipt logs and reviews any discrepancies or damage reports.

4. Accountability

The Clinical Supply Manager or designated person is accountable for ensuring proper documentation, reconciliation, and traceability of CTM from the point of receipt to final usage or disposal.

5. Procedure

5.1 Preparation for CTM Receipt

1. Receive advance shipment notification from sponsor/CRO including:
   • Shipment date
   • Tracking number
   • Expected quantity and batch details
2. Ensure designated receipt area is clean, temperature-monitored, and secure.

5.2 CTM Receipt and Verification

1. Upon delivery, inspect the shipment for:
   • Correct labeling and condition of the package
   • Temperature indicator status (if cold chain)
   • Seals and tamper-evident closure integrity
2. Open the shipment in the presence of PI or delegate.
3. Record the details in Annexure-1: CTM Receipt Log including:
   • Date and time of receipt
   • CTM name, strength, batch number
   • Quantity received
   • Temperature at receipt
   • Remarks on condition/damages (if any)

5.3 Handling of Discrepancies or Damages

1. Note discrepancies/damages in Annexure-2: CTM Discrepancy Report Form.
2. Photograph the damaged material (if applicable).
3. Quarantine the affected CTM and label accordingly.
4. Inform sponsor or CRO within 24 hours and await further instructions.

5.4 Storage and Labeling

1. Store received CTM as per sponsor-specified conditions (e.g., 2–8°C, ambient, -20°C).
2. Label shelves/storage cabinets with CTM name, batch number, and expiry date.
3. Update storage log and ensure access control to CTM storage area.

5.5 Reconciliation and Audit Readiness

1. Maintain updated running inventory in Annexure-3: CTM Inventory Log.
2. Ensure batch-wise reconciliation after dosing completion and at study close-out.
3. Ensure CTM Receipt Log is audit-ready and securely archived in the Trial Master File (TMF).

6. Abbreviations

• CTM: Clinical Trial Material
• IP: Investigational Product
• QA: Quality Assurance
• PI: Principal Investigator
• TMF: Trial Master File

7. Documents

1. CTM Receipt Log – Annexure-1
2. CTM Discrepancy Report Form – Annexure-2
3. CTM Inventory Log – Annexure-3

8. References

• ICH E6(R2) – Good Clinical Practice
• Schedule Y, Drugs and Cosmetics Act, India
• WHO Guidelines on Good Storage and Distribution Practices

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: CTM Receipt Log

Date	CTM Name	Batch No.	Qty Received	Storage Condition	Received By
16/04/2025	Metformin 500 mg	B23M001	200 blisters	Ambient	Sunita Reddy

Annexure-2: CTM Discrepancy Report Form

Date	CTM Name	Issue Identified	Action Taken	Notified To
16/04/2025	Placebo Blister	Damaged seal	Quarantined	CTM Manager

Annexure-3: CTM Inventory Log

Date	CTM Name	Batch No.	Received	Used	Balance	Checked By
17/04/2025	Metformin 500 mg	B23M001	200	50	150	Ajay Verma

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/01/2022	1.0	Initial SOP Release	Compliance with CTM handling	QA Head
17/04/2025	2.0	Added discrepancy handling and storage documentation requirements	Regulatory Alignment	QA Head