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Good
manufacturing practices (GMPs)
January 1999
Good
manufacturing practices (GMPs) lie at the heart of quality. GMPs
comprise a variety of practices that ensure quality including things
such as:
- raw
materials quality assurance
- record-keeping
of substances throughout the manufacturing process
- standards
for cleanliness and safety
- qualifications
of manufacturing personnel
- in-house
testing
- production
and process controls
- warehousing
and distribution
GMPs:
A more reliable means of achieving quality
GMPs
provide quality assurances that off-the-shelf testing cannot. Off-the-shelf
testing relies upon random sampling of a very small subset of the
final product. Enormous resources must be expended to test one substance
-- testing just a few samples of each brand. These tests provide
only a snapshot-in-time view of a product's quality. Fluctuations
in product quality are slow to be discovered via such after-the-fact
testing.
In
contrast, GMPs provide continual measures of quality that can uncover
problems and fluctuations as they occur and before the product is
shipped. Thus, GMPs are a more immediate and consistent way to control
quality.
The
need for GMPs takes on further importance because the issues involved
in developing test methods for dietary supplements are many and
complex. Until methods are further developed, standardized, and
widely accepted, GMPs serve as a primary vehicle for ensuring quality.
Industry
GMP standards
Virtually
every manufacturer adheres to an in-house GMP standard, which varies
from producer to producer. In-house GMPs, while often extremely
effective, do not provide a means for outside verification of quality.
In order to provide such verification, many are now embracing industry-standard
GMPs which are usually subject to an independent outside audit for
compliance.
A
coalition of industry trade associations -- the Council for Responsible
Nutrition (CRN), the National Nutritional Foods Association (NNFA),
the American Herbal Products Association (AHPA), and the Consumer
Healthcare Products Association (CHPA) -- developed a draft version
of GMPs that they submitted to the FDA in 1995. The FDA subsequently
published this GMP in 1997. They are not currently enforced.
The
National Nutritional Foods Association (NNFA) ComPLI Committee,
with their Advisory Board, developed a new GMP to a level deemed
to be effective and appropriate. The NNFA GMP Certification Program
was tested during 1998 and goes into effect in 1999. All NNFA supplier
members will be required to comply with NNFA's GMP standards. Compliance
entitles producers to inclusion of the NNFA GMP seal in product
literature and on labels.
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