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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. For example, in Mexico, approximately 35 alcohol-based hand sanitizer quality incidents were reported.
On February 25, 2021, USP hosted a Global Seminar, Ensuring Quality Hand Sanitizer Production During COVID-19, to help ensure quality alcohol-based hand sanitizer production and support the safe use of alcohol-based hand sanitizer.
Seminar Topics
Presenters and panelists from USP, regulators, industry, and public health institutions will 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
Presenters and Panelists
Regulatory and Industry
- Juan Carlos Galicia Marrufo, Assistant Director for Assessment of Healthcare Services and Supplies | COFEPRIS
- Itamar de Falco Junior, Manager, Department of Hygiene, Perfumery, Cosmetics and Sanitizing Products (GHCOS) | ANVISA
- Leonardo de Souza Lopes, Public Health Technologist, Responsible for the Cosmetics and Sanitizing Sector of the Chemistry Department | National Institute of Quality Control in Health (INCQS)
- Francis Godwin, M.B.A., Office Director, Office of Manufacturing Quality | U.S. FDA
- Rafael Hernandez, Deputy Director for Publications | Mexican Pharmacopeia
- Edvaldo Oliveira Neves, Health Regulation Expert, Department of Official Control Laboratories (GELAS) | ANVISA
- Debora Rodrigues, Science Manager in Microbiology | Natura Inovação e Tecnologia de Cosméticos S / A and ABIHPEC representative (Brazilian Association of the Personal Hygiene, Perfumery and Cosmetics Industry)
- Adriana Sant'Ana da Silva, Public Health Technologist, Head of Chemistry Department | National Institute of Quality Control in Health (INCQS)
- Juan Pablo Solis, Head of Operations for Medical Segment | Becton Dickinson
- Ivan Teixeira, Ad hoc Advisor | ANFARMAG (Brazilian Association of Compounding Pharmacists
USP
- Ronald T. Piervincenzi, Ph.D., Chief Executive Officer
- Danita Broyles, M.S., Senior Market Development Manager
- Efren Elias, Public Policy & Regulatory Affairs
- Desmond G. Hunt, Ph.D., Principal Scientific Liaison, Science-General Chapters
- Catherine Sheehan, DRSc, M.S., M.S., Senior Director, Science-Excipients
- Misti Spann, Pharm.D., Scientific Liaison, Science, Healthcare Quality & Safety
- Luciana Shimizu Takara, Sr. Manager, Government & Regulatory Affairs
- Nurisha Wade, Vice President, Healthcare Quality & Safety
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, healthcare provider groups, or public health institutions
Event Summary
Event Presentations
01 Why Quality Alcohol-based Hand Sanitizer Matters, Nurisha Wade
02 Ensuring the Public's Trust in Using Alcohol-based Hand Sanitizer - Francis Godwin
03 Formulating Quality Alcohol-based Hand Santizers - Catherine Sheehan
04 USP Ingredient Verification Program - Danita Broyles
05 Labeling Packaging and Storage - Misti Spann06 Labeling Packaging and Storage - Desmond Hunt
For further information, please contact Jacqueline D. Starkes.