Protocol for Management of Investigational Products in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the handling, storage, and accountability of study drugs or investigational products used in Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the receipt, storage, dispensing, administration, and accountability of study drugs or investigational products, including Principal Investigators, Pharmacists, Study Coordinators, and Clinical Research Associates.

Responsibilities

• The Principal Investigator (PI) or Study Coordinator is responsible for overall oversight of study drug management and ensuring compliance with the study protocol and regulatory requirements.
• The Pharmacy or Investigational Drug Service is responsible for receiving, storing, dispensing, and managing the inventory of study drugs or investigational products.
• The Study Team is responsible for ensuring that study drugs are handled and administered according to the study protocol and any applicable regulatory guidelines.

Procedure

1. Receive study drugs or investigational products from the sponsor or designated supplier, documenting receipt and storage conditions.
2. Store study drugs in accordance with the manufacturer’s instructions, study protocol requirements, and applicable regulatory guidelines.
3. Ensure that study drugs are securely stored in a designated area with restricted access to authorized personnel only.
4. Dispense study drugs to study participants or designated personnel according to the study protocol and dispensing procedures.
5. Maintain accurate and up-to-date records of study drug inventory, including receipt, dispensing, and destruction/disposal.
6. Monitor study drug storage conditions regularly, including temperature and humidity, and take appropriate action if deviations are detected.
7. Handle any study drug deviations, discrepancies, or adverse events promptly and document them in the study records.
8. Dispose of unused or expired study drugs in accordance with applicable regulations and sponsor instructions.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• PI – Principal Investigator

Documents

• Study Drug Inventory Log
• Study Drug Dispensing Records
• Temperature Monitoring Records
• Study Drug Destruction/Disposal Documentation

Reference

Good Clinical Practice guidelines (ICH E6) and relevant regulatory requirements for investigational product management.

SOP Version

Version 1.0