Course Description: Alcohol-based hand sanitizer is an important element in infection prevention, especially during the COVID-19 pandemic. However, when quality is compromised, it can be less effective against infection transmission and can also lead to user harm. COVID-19-related supply chain pressures have created global shortages that led to new vendors, materials, and production pathways to meet demand. These fast-paced changes have caused an emergence of quality incidents both regionally and globally. Globally, over 200 alcohol-based hand sanitizer quality incidents have been reported in 2020. Specifically, in the United States, approximately 80 alcohol-based hand sanitizer quality incidents were reported in 2020.
Presenters from USP, U.S. FDA, industry, and public health institutions discuss the global and regional quality risks and solutions when producing alcohol-based hand sanitizer (including its ingredients such as alcohol), including:
- Global quality challenges and public health impact of alcohol-based hand sanitizers from import/export regulations to clinical perspectives on the frontline treating consequences from subquality products
- Regional regulatory and public health strategies to increase trust in alcohol-based hand sanitizers
- Standards, current Good Manufacturing Practices (cGMPs), and mitigation strategies for the production (including ingredients such as alcohol), labeling, packaging, storage, transportation, and distribution of alcohol-based hand sanitizer
- Ingredient verification services to help ensure the quality of the ingredients used in alcohol-based hand sanitizer as well as assist with the qualification of ingredient suppliers
- Manufacturing perspectives and best practices from industry peers’ sharing insights on quality in action
Who should attend:
- Manufacturers with alcohol-based hand sanitizers as part of their production portfolio
- Regulatory agencies who support alcohol-based hand sanitizer manufacturers
- Other interested industry groups