Expedited Solutions Will Help Manufacturers Ensure Compliance with New Rule
Ann Arbor, MI - The U.S. Food and Drug Administration (FDA) recently announced the publication of the final regulations for dietary supplement current Good Manufacturing Practices (cGMPs). To help manufacturers make sure they comply with the new regulations, Global Lifescience Solutions™, LLC (GLS) is offering special consulting services.
The cGMPs final rule requires that guidelines are in place for dietary supplements to ensure proper processing, manufacturing, labeling, and storage of ingredients and finished products. The final rule applies to all domestic and foreign companies that manufacture, package, label, store and distribute dietary supplements in the U.S.
GLS, an NSF International Company, is a contract research and consulting firm that has over five years of experience providing a wide array of services to the dietary supplement and pharmaceutical industries, including risk assessments, efficacy testing and label reviews. In conjunction with these service offerings, GLS also performs preliminary audits to ensure a facility is in full compliance with cGMPs.
“With the new GMPs out, now is the time to offer the dietary supplement and pharmaceutical industries the solutions they need to meet their deadline,” said Aline Lindbeck, Ph.D., general manager, Global Lifescience Solutions. “Our goal is to help manufacturers improve their quality programs from initial implementation to ensuring ongoing compliance.”
The final cGMPs are effective August 24, 2007, but will take up to three years to implement, depending on the size of the company. According to the FDA, companies with more than 500 employees have until June 2008. Companies with less than 500 employees have until June 2009, and companies with fewer than 20 employees have until June 2010 to comply with new regulations.
In addition to GMP consulting, GLS also offers the following services to the dietary supplements and pharmaceuticals industries:
- Melamine testing
- Stability storage and testing
- Toxicity testing through the GLS high-content screening cellular platform
- Label claim and contaminant testing
- New Dietary Ingredient (NDI) notification submission and safety assessment preparation
- Method development and validation
About Global Lifescience Solutions™, LLC: Global Lifescience Solutions™, LLC, an NSF International Company, is a contract research and consulting firm offering integrated technical services for companies focused on product innovations in the fields of pharmaceuticals, biotechnology, dietary supplements, food and nanotechnology (www.nsf-gls.com). With clients ranging from innovative start-up companies to Fortune 100 and multi-national corporations, GLS provides comprehensive research services that address client needs for basic research, proof of concept, product regulatory registration, and field trials and validation.