Orcas Naturals, Inc. and Unique Encapsulation Technology, LLC, (UET) are proud to announce they have attained 21 CFR 111:4-2-16 certification in accordance with the Retail Certification Program. This means that their joint facility at 9 Lenel Rd. in Landing, NJ, was audited by UL Registrar, LLC, using an accredited certification process to determine that the organization is found in conformance with Good Manufacturing Practice (GMP) guidelines, 21 CFR 111:4-2016.
GMPs are guidelines that provide a system of processes, procedures, and documentation to assure a product has the identity, strength, composition, quality, and purity that appear on the product label. These GMP requirements are listed under FD&C Act section 520(f).
The UL Registrar LLC GMP Certification Program enables manufactures to become independently registered by UL to meet GMP requirements for the manufacturing, packaging, holding, and distribution of finished products, components, ingredients, and/or raw materials. “Conformance to the UL standard adds credence to our in-house QC laboratory protocols and vendor qualification measures, helping us demonstrate our commitment o public safety,” says K G Rao, President of Orcas Naturals and UET.
The certification covers the Landing, NJ, location and includes the manufacturing, packaging, warehousing, and distribution of dietary supplements as raw materials as well as powders and liquid-filled capsules.
Orcas Naturals and UET created a strategic alliance that provides clients with one-stop service for turnkey ingredient sourcing, conventional and customized formulations, and unique filling technologies.
“The UL GMP certification for facility operation and management systems holds us accountable to our vision of delivering quality ingredients in state of the art capsules,” notes Rao..“We fulfill a unique niche in our market, offering small batch sizes, delivering rapid turnaround times and leading with a strong team of quality professionals. As an industry authority, GMP status strengthens our customers’ confidence in our mission to help them differentiate their final product in a competitive market.”