February 3, 2010- Santa Ana, Ca- Robinson Pharma Inc., (RPI) announced that it successfully completed a surveillance audit for cGMP compliant manufacture of dietary supplements to the standards outlined in 21CFR Part 111. The audit was performed by STR, a leading global third party testing and auditing firm focused on quality systems and analysis. RPI, a leading vendor of private label, store brand, and contract manufactured dietary supplements, is committed to continue its company wide quality initiative.
This past year, medium sized firms (20-500 employees) such as RPI, became subject to federally mandated cGMPs for manufacturing of dietary supplements under the DSHEA rule. The new standards raised the bar on quality making manufacturers accountable under federal law and FDA oversight for identity, purity, and potency of ingredients as well as the traditional standards for all aspects of facility cleanliness and suitability, staff qualification and training, and manufacturing practices and documentation. The new standards provide further assurance that customers can expect that products are properly identified and labeled, contain only the ingredients listed, that they are free of contaminates, and that they will meet label claim.
The STR quality systems audit assesses the ability of a companies manufacturing process to effectively and consistently produce correctly labeled, pure, and safe product. STR analyzed the RPI Standard Operation Procedures (SOPs), staff qualifications, staff training program, and facility adequacy and cleanliness. All aspects of the manufacturing process were reviewed including receipt and authentication of ingredients, the production process, post production product analysis, product handling, packaging, storage, and record keeping. RPI, which was holds a drug manufacturing license issued by the state of California, was shown to comply with the standards mandated by the STR RQP. The RQP standards were originally created to assure safely, purity, and label claim compliance for dietary supplements marketed in a leading national retail chain.
RPI president and founder, Tuong Nguyen stated, “Our continued commitment to constant process improvement and world class quality has been embraced by our dedicated team. They have demonstrated that we have maintained a high level of quality simultaneous to expanding our production capacity and speeding our pace of delivery to our customers. This past year we invested in growing our laboratories and our quality assurance and analytical teams. These investments have already allowed us to operate more effectively in an increasingly demanding quality environment. RPI is committed to our total quality program and we will continue to invest in systems and personnel to support our goal of providing the industry with the most effective contract manufacturing and private label services available.” “Partnering with STR, along with other key strategic initiatives, has transformed RPI into a leading private label and store brand supplier to some of the largest marketers of dietary supplements in the United States” stated Kenn Israel, Vice President of Marketing. “As RPI grows under the careful leadership our CEO, we have focused on providing an increased level of service to our core customers, we will leverage this proven competence to allow us to expand and engage the larger domestic and international opportunities that we know we can now effectively manage and support.”
Robinson Pharma Inc. (RPI) is a minority owned, Southern California based, drug licensed, full service provider of private label, store brand, and contract manufacturing services for dietary supplements. RPI features the largest soft gel encapsulation capacity in the U.S. with 22 continuous dry encapsulation lines capable of producing over 12 billion soft gels per year. Production capabilities include tablet compression, capsule filling, enteric coating of soft gels and tablets, custom imprinting, and a range of packaging options including bottles, blister packaging boxing, and bulk product. Additional services include product development and ingredient sourcing. Robinson Pharma Inc. provides rapid turnaround on all projects and offers highly competitive pricing. Robinson Pharma Inc. maintains 400,000 square feet of production, operations, and warehousing facilities. For more information please email [email protected], Phone (714) 241-0235 or visit www.RobinsonPharma.com