This webinar will provide an in-depth overview of regulatory expectations and industry best practices related to allowable excess volume and content in injectable drugs and biological products. Participants will learn how excess volume is defined, measured, and justified, along with key considerations for compliance with international guidelines and regulations. Practical examples will highlight common challenges, quality control measures, and strategies to ensure product consistency, patient safety, and regulatory approval.
Key Learning Objectives
- Understand regulatory requirements for allowable excess volume and content in injectable drug and biological products, with emphasis on FDA and international guidelines.
- Identify methods for measuring and justifying excess volume, including best practices for documentation and compliance.
- Recognize common challenges and pitfalls in managing excess volume during product development, manufacturing, and quality control.
- Apply strategies to ensure consistency and patient safety, while supporting successful regulatory submissions and approvals.
