Standard Operating Procedure for Handling of Investigational Products

1) Purpose

The purpose of this SOP is to establish guidelines for the handling of investigational products to ensure compliance with regulatory requirements and maintain product integrity in pharmaceutical clinical trials.

2) Scope

This SOP applies to all personnel involved in handling investigational products within pharmaceutical clinical trial facilities, including storage, dispensing, and return procedures.

3) Responsibilities

The Clinical Research Department is responsible for implementing and adhering to this SOP. The Clinical Research Coordinator oversees the handling of investigational products.

4) Procedure

1. Receipt and Storage
   1. Receive investigational products from sponsors or authorized distributors following documented procedures.
   2. Verify shipment contents, storage conditions, and temperature monitoring requirements.
2. Dispensing and Administration
   1. Dispense investigational products to eligible participants according to protocol requirements and randomization schedules.
   2. Document dispensing activities, including product batch numbers and expiration dates.
3. Return and Destruction
   1. Manage returns of unused investigational products to sponsors or designated return facilities.
   2. Document returned products and ensure compliance with disposal or destruction procedures.
4. Documentation and Records
   1. Maintain accurate records of investigational product receipt, dispensing, and return activities.
   2. Document temperature excursions, deviations, and adverse events related to investigational product handling.
5. Training and Compliance
   1. Provide training to personnel involved in handling investigational products on protocol requirements, storage conditions, and regulatory guidelines.
   2. Ensure compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements.

5) Abbreviations, if any

GCP: Good Clinical Practice

6) Documents, if any

Investigational Product Handling Logs, Temperature Monitoring Records, Disposal Certificates, Training Records

7) Reference, if any

ICH E6 guidelines for Good Clinical Practice (GCP), and relevant regulatory requirements for investigational product handling in pharmaceutical clinical trials.

8) SOP Version

Version 1.0