GMP
Quality Seal Reaches Supplement Shelves
12
February 2001
by Wyn Snow, Managing Editor
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Copyright
NNFA;
reprinted with permission. |
Until
recently, finding out if a supplement product is well made required
the finely honed persistence of a private detective. You asked a
company's Quality Assurance professionals a slew of highly technical
questions about matters like microbial contamination, cleaning solutions,
and personnel training. And you often got vague or evasive answers
because such questions usually intrude into proprietary aspects
of production.
But
the good manufacturing practices (GMP) inspection program of the
National Nutritional Foods Association (NNFA) -- a trade organization
encompassing approximately 1000 producers as well as retailers --
is changing all that. Companies are being inspected by independent,
third-party professionals who are getting answers to a long checklist
of technical questions because this inspection program protects
corporate privacy. As of January 2001, twenty companies have now
completed NNFA's inspection and certification process and can use
the GMP seal on their product labels and literature (see
list below).
GMP
inspection covers all aspects of production
Many
quality issues are included in the audit, such as double checking
the identify of raw materials to ensure one has the correct substance,
testing for the presence of heavy metals or microbials or other
contaminants, and use of stability studies to determine accurate
expiration dates. The inspection covers the entire production process
-- from receiving raw materials to shipping completed products out
the door.
"This
program will help establish credibility in the eyes of consumers,"
according to Jim Roza, QA Manager of Now Foods, whose company was
inspected in July 2000. "The person who inspected us was a 40-year
veteran of FDA inspections who is very experienced and has travelled
all over the world doing this kind of work." Roza believes the NNFA's
GMP program will dovetail nicely with the FDA's proposed GMP standard,
which should be published early this year (2001).
GMP
program features independent, third-party inspections
NNFA's
inspection program requires that auditing companies must be independent,
with no conflict of interest, for each company that they inspect.
The inspectors are trained to conduct GMP audits according to a
checklist and performance rating system developed by NNFA.
Companies
that have passed the GMP audit
The
following companies have passed NNFA's GMP inspection and certification
process as of January 2001:
- BIOSINT USA, Larchmont NY
- Cardinal Nutrition Inc, Vancouver WA
- Country Life, Hauppauge NY
- Garden State Nutritionals, West Caldwell NJ
- Health Factors International, Tempe AZ
- Leiner Health Products, Carson CA
- Merical VitaPak, Anaheim CA
- Nature's Herbs, American Fork UT
- Nature's Life, Garden Grove CA
- Nature's Products, Sunrise FL
- Nature's Way, Springfield UT
- NBTY Inc, Bohemia NY
- NHK Laboratories, Santa Fe Springs CA
- Now Foods, Bloomingdale IL
- Nutrition Formulators, Hialeah FL
- Soft Gel Technology/Optipure, Los Angeles CA
- Tint Corporation, Irwindale CA
- Twin Laboratories Inc, Hauppauge NY
- Vitamer/Anabolic Labs, Irvine CA
- Wakunaga of America Co, Ltd, Mission Viejo CA
GMP
seal empowers consumers to make quality choices
Having
a solid GMP program ensures that a manufacturer is producing consistent
quality -- from batch to batch, lot to lot, bottle to bottle and
tablet to tablet. Thus, labels with this seal allow consumers to
buy with confidence, knowing that the product is well made.
Sources
Jim
Roza, Quality Assurance (QA) Manager, Now Foods, Bloomingdale IL.
Personal communication, 10 January 2001.
Vicki
Whitsitt, Science and QA Program Manager, National Nutritional Foods
Association, Newport Beach CA. Personal communication, 13 November
2000 and 12 February 2001.
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