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Schaefer Technologies |
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 Company Information Contact Information Main Page
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 Manufactured to meet Federal GMPs for Dietary Supplements and pharmaceutical-biotech cGMP
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