(Westbury, NY – April 6, 2020) For industries not accustomed to working with the FDA or interpreting FDA regulations and guidance in the manufacture of hand sanitizers, this can be a challenging time. In support of these companies’ efforts to aid in stemming the advance of COVID-19, Lachman Consultant Services, Inc. (“Lachman Consultants”) is reaching out to U.S. distilleries and breweries to provide support and guidance for the manufacture of hand sanitizers.
For those companies who currently work in the pharmaceutical manufacturing or other affiliated manufacturing sectors, the U.S. Food and Drug Administration (FDA) Guidance and OTC Monographs will be familiar and generally easy to implement. But for those in other, unrelated industries such as brewers and distillers, who are not accustomed to working with FDA or interpreting FDA regulations and guidance, Lachman Consultants is offering a simple, layperson’s roadmap to both the manufacturing and labeling requirements. This service is provided at no cost to companies in these industries as well as other industries looking to take on this manufacturing challenge and create products that promote sanitary conditions and help prevent the spread of the COVID-19 virus.
On April 1, 2020, Lachman Consultants distributed a simplified interpretation of FDA’s most recent Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry. You can review the full guidance on the Food & Drug Administration website here https://www.fda.gov/home.
Interested parties who have not received outreach from Lachman Consultants directly and would like more information about this effort can Contact Lachman Consultants here. And for assistance with technical, compliance or regulatory support in bringing your hand sanitizer to a community in need, please contact Lachman Consultants to discuss how they can provide a remote support team for your project.
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ABOUT LACHMAN CONSULTANTS
Founded in 1978, Lachman Consultants maintains three practice groups: Compliance, Regulatory Affairs, and Science and Technology. Each practice offers industry-leading experience and expertise in its area of focus. Lachman Consultants serves emerging-to-enterprise organizations on a worldwide basis in the Pharmaceutical, Biotechnology, Biologics, Device, and Related Life Science Industries. Lachman Consultants delivers highly effective and proven solutions that include FDA-Related Services, Audits, Quality Assurance & Controls, Scientific and Technical Assistance, Systems Evaluation, and Training, which have been shown to consistently exceed client requirements and expectations.