Protocol for Inventory Control and Management of Study Materials in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the management of study supplies, including investigational medicinal products (IMPs), ancillary supplies, and study materials, in Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry.

Scope

This SOP applies to all study personnel involved in the receipt, storage, distribution, and accountability of study supplies, including Investigators, Study Coordinators, Pharmacists, and Clinical Research Associates (CRAs).

Responsibilities

• The Investigator is responsible for ensuring the proper storage, handling, and accountability of study supplies at the study site, in accordance with Good Clinical Practice (GCP) guidelines and study protocols.
• The Study Coordinator is responsible for maintaining accurate records of study supplies, coordinating supply shipments, and reconciling inventory discrepancies throughout the study conduct.
• The Pharmacist is responsible for dispensing and labeling investigational medicinal products (IMPs), maintaining controlled drug records, and ensuring compliance with regulatory requirements for drug storage and handling.
• The Clinical Research Associate (CRA) is responsible for monitoring study supply management practices at study sites, verifying compliance with study protocols and regulatory requirements, and documenting any deviations or discrepancies.

Procedure

1. Establish procedures for the receipt, storage, distribution, and accountability of study supplies, including investigational medicinal products (IMPs), ancillary supplies, and study materials, at study sites.
2. Designate a secure and temperature-controlled area for the storage of study supplies, with restricted access to authorized personnel only, to ensure compliance with regulatory requirements and product stability.
3. Receive study supplies in accordance with shipping and handling procedures specified by the sponsor or study sponsor, including verification of shipment contents, temperature monitoring, and documentation of receipt.
4. Label investigational medicinal products (IMPs) with unique identifiers, study codes, expiration dates, and storage conditions, in compliance with regulatory requirements and sponsor instructions.
5. Maintain accurate and up-to-date inventory records for all study supplies, including quantities received, dispensed, returned, and remaining on hand, using a designated inventory management system or logbook.
6. Monitor study supply levels regularly throughout the study conduct, replenishing supplies as needed to ensure uninterrupted study operations and participant access to study materials.
7. Document all study supply transactions, including dispensing, returns, and wastage, in study documentation, case report forms (CRFs), and inventory logs, to maintain a complete audit trail of supply management activities.
8. Conduct regular reconciliations of study supply inventory records with actual physical counts, investigating and resolving any discrepancies identified through inventory audits or site visits.
9. Ensure compliance with regulatory requirements, study protocols, and sponsor instructions for the handling, storage, and accountability of investigational medicinal products (IMPs) and study supplies throughout the study conduct.
10. Implement corrective and preventive actions (CAPAs) to address any deficiencies or deviations in study supply management practices, ensuring continuous improvement and adherence to best practices.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• IMP – Investigational Medicinal Product
• GCP – Good Clinical Practice
• CRA – Clinical Research Associate
• CRF – Case Report Form
• CAPA – Corrective and Preventive Actions

Documents

• Inventory Management Log
• Shipping and Receiving Records
• Study Protocol
• Regulatory Guidelines for Drug Storage and Handling

Reference

International Council for Harmonisation (ICH) E6 Good Clinical Practice guidelines and relevant regulatory guidelines for the management of investigational medicinal products (IMPs) and study supplies in clinical research.

SOP Version

Version 1.0