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Nutraceutical and cGMP Compliance in Manufacturing
The dietary supplement and nutraceutical market is changing rapidly in response to the FDA's new Dietary Supplement Current Good Manufacturing Practices (cGMPS) "Final Rule" (21 CFR Part 111), published on June 25, 2007. The Final Rule adopts all requirements specified in 21 CFR 210 and 211, which affect pharmaceutical manufacturers, and apply to all companies that manufacture, package, label, or hold dietary supplements and nutraceuticals. Dietary supplements or nutraceuticals imported from outside the United States are also subject to the Final Rule.
Schaefer Technologies, Inc. is a leading machine manufacturer of capsule filling, capsule banding and capsule polishing equipment
with a long and successful history of manufacturing and delivering quality CGMP compliant equipment and products to the pharmaceutical
and nutraceutical (natural foods) industries. Manufacturing and exporting quality automatic and semi-automatic capsule filling and banding
machines for pellets, tablets, powder, and liquids. We also manufacture capsule inspection and capsule polishing machines.
Products are supplied worldwide and we offer custom designs and OEM services which are always welcomed. Shown
below are the STI Model LF-10 and the STI Model 10 ver 4.2. Both are cGMP Compliant capsule filling machines.
June 25, 2009: Fewer than 500 but more than 20 employees
June 25, 2008: 500 or more employees Companies found to be out of compliance could be subject to 483s, warning letters, or non-approvable letters indicating a regulatory deviation. The ruling affects any company that manufactures or sells dietary supplements, nutraceuticals, and over the counter (OTC) products intended to be used by the public. CGMPS are bringing a new level of quality and accountability to the nutraceutical industry. Those companies who have specialized in low cost production without making adequate investments in quality systems and personnel training will be at a disadvantage. For many companies it will be too little, too late. For others it will be the beginning of a 'golden-age' of stability and growth. Article: GMP in nutraceuticals manufacturing ISPE (International Society for Pharmaceutical Engineering) and cGMP Contract Manufacturing Guidelines: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM353925.pdf