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“headline”: “SOP for IP (Investigational Product) Receipt and Verification in Clinical Trials”,
“description”: “This SOP establishes procedures for the receipt and verification of investigational products (IP) in clinical trials, ensuring accountability, compliance, and regulatory adherence under ICH GCP, FDA, EMA, CDSCO, and WHO standards.”,
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Published on 23/12/2025
Standard Operating Procedure for IP (Investigational Product) Receipt and Verification
| Department | Clinical Research |
| SOP No. | CR/IP/031/2025 |
| Supersedes | NA |
| Page No. | 1 of 22 |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
Purpose
The purpose of this SOP is to outline standardized procedures for the receipt and verification of investigational products (IP) at clinical trial
Scope
This SOP applies to investigators, pharmacists, study coordinators, and other authorized site personnel involved in the receipt, verification, and documentation of investigational products. It covers pharmaceuticals, biologics, medical devices, comparators, and placebos used in clinical trials.
Responsibilities
- Principal Investigator (PI): Oversees receipt and ensures IP verification is completed as per protocol and regulatory requirements.
- Pharmacist/Authorized Designee: Performs receipt checks, verifies product details, and documents in IP Receipt Log.
- Study Coordinator: Ensures shipment documentation is filed in ISF and TMF.
- Sponsor/CRO: Provides shipping records, monitors compliance, and reviews IP accountability during site visits.
- Quality Assurance Officer: Reviews IP receipt and verification logs during audits and inspections.
Accountability
The PI is accountable for ensuring that IP receipt and verification activities are performed correctly and documented in compliance with GCP requirements. Sponsors are accountable for oversight and ensuring chain of custody documentation is accurate.
Procedure
1. Preparation for Receipt
Notify PI or pharmacist prior to scheduled shipment.
Ensure designated staff are trained in IP receipt procedures.
2. Receipt of Shipment
Upon arrival, check shipping labels, temperature monitors, and condition of packaging.
Record date and time of receipt in the IP Receipt Log (Annexure-1).
3. Verification of IP
Verify IP details against shipping documents (Annexure-2).
Confirm batch/lot number, expiry date, quantity, and labeling compliance.
Report discrepancies immediately to sponsor/CRO.
4. Documentation
Complete IP Receipt Form signed by responsible staff.
File shipping documents, receipts, and verification forms in ISF and TMF.
5. Temperature Monitoring
Review temperature log data attached with shipment.
Document excursions, if any, and escalate to sponsor for disposition.
6. Archiving
Archive receipt and verification records for at least 5 years post-trial or longer as per regulations.
Abbreviations
- SOP: Standard Operating Procedure
- PI: Principal Investigator
- IP: Investigational Product
- CRO: Clinical Research Organization
- ISF: Investigator Site File
- TMF: Trial Master File
- QA: Quality Assurance
Documents
- IP Receipt Log (Annexure-1)
- IP Verification Form (Annexure-2)
- Shipment Condition Report (Annexure-3)
References
- ICH E6(R2) – Good Clinical Practice
- US FDA – Clinical Trials Drug Development
- EMA Clinical Trial Regulation
- CDSCO Clinical Trial Rules, 2019
- WHO – Clinical Research Quality Standards
Version: 1.0
Approval Section
| Prepared By | Rajesh Kumar, Clinical Research Pharmacist |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Principal Investigator |
Annexures
Annexure-1: IP Receipt Log
| Date | Shipment No. | IP Name | Batch/Lot No. | Quantity | Received By |
|---|---|---|---|---|---|
| 12/09/2025 | SHP-101 | Investigational Drug X | LOT-2025A | 200 vials | Ravi Kumar |
Annexure-2: IP Verification Form
| Shipment No. | Batch/Lot No. | Expiry Date | Quantity Verified | Discrepancies | Verified By |
|---|---|---|---|---|---|
| SHP-101 | LOT-2025A | 30/12/2026 | 200 vials | None | Sunita Sharma |
Annexure-3: Shipment Condition Report
| Shipment No. | Packaging Condition | Temperature Log Reviewed | Remarks |
|---|---|---|---|
| SHP-101 | Intact | Yes | No deviations |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Head, Clinical Research |
For more SOPs visit: Pharma SOP