IP disposition and release are essential aspects of clinical trial conduct. These processes ensure compliance with Good Practice (GxP) guidelines and regulatory requirements, maintaining the integrity, safety, and quality of clinical trial data. The IP release process involves several crucial steps to ensure the investigational product (IP) meets all necessary quality, regulatory, and protocol-specific requirements before it is administered to trial participants. This process ensures that the IP is safe, effective, and ready for use in clinical trials. This course will provide a detailed overview of the key steps involved in the IP release process for clinical use, covering every aspect from manufacturing to final release. Additionally, we will discuss IP disposition, which involves managing the final status of investigational products after their use in a clinical trial. This includes ensuring that all IPs—whether used, unused, expired, or damaged—are properly accounted for and managed according to regulatory and study-specific requirements.

Areas Covered

Introduction

An overview

Manufacturing and Initial Quality Control

Quality Assurance Review

Certification and Batch Release

Packaging and Labeling

Release Authorization

Distribution

Ongoing Monitoring and Accountability

Q & A

Who Should Attend    

CMC, Quality Unit (QA and QC), Regulatory Affairs Managers

Why Should You Attend

This course is focused on Investigational Product disposition for Clinical trials. Gives a comprehensive overview of the relevant GxP regulations, the necessary steps to follow, documentation requirements, and processes for releasing product lots for clinical use.

The responsibilities of the Sponsor’s Quality Unit (QU) for GMP product manufacturing, testing, labeling, packaging, and release will be reviewed and discussed during the course.

Topic Background

For each batch of an Investigational Product (IP) at all stages of production, the Quality Unit (QU) must review the Batch Production and Control Records (BPCR), a collection of records that includes manufacturing instructions/parameters, analytical testing, and supplementary documentation before deciding on its use in clinical trials.

This decision, known as disposition, is based on a review of predetermined manufacturing and, if applicable, testing records to determine whether the product batch can be used for its intended purpose.