Standard Operating Procedure for Clinical Trial Material (CTM) Receipt Log in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/132/2025 |
| Supersedes | SOP/BA-BE/132/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To establish a standardized procedure for receiving and logging Clinical Trial Material (CTM) used in BA/BE studies, ensuring traceability, accountability, and compliance with GCP and regulatory requirements.
2. Scope
This SOP applies to all BA/BE study-related clinical sites, pharmacy staff, clinical research coordinators, and investigators responsible for receiving investigational product (IP) and related materials at the study site.
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
- Receive advance shipment notification from sponsor/CRO including:
- Shipment date
- Tracking number
- Expected quantity and batch details
- Ensure designated receipt area is clean, temperature-monitored, and secure.
5.2 CTM Receipt and Verification
- 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
- Open the shipment in the presence of PI or delegate.
- 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
- Note discrepancies/damages in Annexure-2: CTM Discrepancy Report Form.
- Photograph the damaged material (if applicable).
- Quarantine the affected CTM and label accordingly.
- Inform sponsor or CRO within 24 hours and await further instructions.
5.4 Storage and Labeling
- Store received CTM as per sponsor-specified conditions (e.g., 2–8°C, ambient, -20°C).
- Label shelves/storage cabinets with CTM name, batch number, and expiry date.
- Update storage log and ensure access control to CTM storage area.
5.5 Reconciliation and Audit Readiness
- Maintain updated running inventory in Annexure-3: CTM Inventory Log.
- Ensure batch-wise reconciliation after dosing completion and at study close-out.
- 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
- CTM Receipt Log – Annexure-1
- CTM Discrepancy Report Form – Annexure-2
- 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 |