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Standard Operating Procedure for IP (Investigational Product) Receipt and Verification

Purpose

The purpose of this SOP is to outline standardized procedures for the receipt and verification of investigational products (IP) at clinical trial sites. This ensures that the product is received in good condition, verified against shipping documents, and appropriately recorded for accountability and regulatory compliance.

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

1. IP Receipt Log (Annexure-1)
2. IP Verification Form (Annexure-2)
3. 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

Annexures

Annexure-1: IP Receipt Log

Annexure-2: IP Verification Form

Annexure-3: Shipment Condition Report

Revision History

For more SOPs visit: Pharma SOP