Lachman Consultants is reaching out to U.S. distilleries and fermenters to provide support and guidance for the manufacture of hand sanitizers. In response to several phone calls from industries wanting to help in the COVID-19 efforts, Lachman is responding with an interpretation of the most recent guidance from the U.S. Food and Drug Administration (here and here).
For industry partners currently working in the pharmaceutical manufacturing or contract manufacturing business, interpretation of the FDA Guidance and OTC Monographs is routine and generally easy to apply. However, Lachman recognizes that, for industries not accustomed to working with the FDA or interpreting FDA regulations and guidance, this can be a challenging time.
We are all in this together. Today, Lachman is reaching out to distilleries (spirits) and fermenters (breweries) to provide a simplified interpretation of the FDA Guidance and to offer a layman’s roadmap to both the manufacturing and labeling requirements. This service is provided at no cost to these industries and any other industry taking on this challenge.
If you have not received our outreach and would like to receive this information, please contact Lachman Consultants (here). If you have received this outreach and need technical, compliance, or regulatory support in bringing the sanitizer to the community of need, please contact us to discuss how we can provide a remote support team to your project.
In these challenging times, it is important, now more than ever, especially during this pandemic, to remember that meeting public health needs requires all-out efforts of industry, academia, government, and consultant expertise. We are dedicated to our collective cause.