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Quality in Focus: Diethylene and Ethylene Glycol Challenges
Session Chair(s)
Chaitanya Koduri
Director, International Government and Regulatory Engagement
US Pharmacopeia, United States
Participants will delve into the US FDA's regulatory guidance, exploring the testing protocols for high-risk drug components and explore the essential requirements and recommended practices to ensure product safety and compliance.
Learning Objective : Recognize key factors contributing to diethylene glycol (DEG) and ethylene glycol (EG) contamination; Examine the US FDA's regulatory guidance, delving into the testing procedures for high-risk drug components contaminated with DEG and EG; Explore requirements and recommended practices for manufacturers, repackagers, preparers, and distributors.
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