Barringer & Associates,
Inc.,
GOOD MANUFACTURING PRACTICES
Good manufacturing practices (GMP)
build a common culture for avoiding: wasted time, wasted effort, and
controversy. GMP helps ensure our products
are safe, effective, and meet standards when assembled and operated using
recommended practices and guidelines.
GMP supplements QA manuals and industry standards for quality.
GMP requires continuing, consistent, control of production operations
in a disciplined manner. Discipline is a
keystone for manufacturing operations with insistence on performance within the
control limits for all operations.
GMP strives for preventing product deficiencies, and reduces incidences
of non-conforming products. It requires a formal corrective action system for
fixing problems, including early detection of deficiencies. Corrective action helps maintain predictable
manufacturing schedules and thus restrains costs by doing things right the
first time.
GMP relies on educated, trained, and skilled personnel in each
facility. Each manufacturing operation
must have personnel who assure correct performance of the operations, as
required by the company, for conducting its business. GMP requires remedial job instructions for
employees whose performance produces non-conforming products so as to keep
product with errors from mixing with good product. GMP expects appropriate design and
installation of production equipment so the job can be performed
correctly. Likewise the equipment must
be inspected, adjusted, and operated correctly.
GMP expects buildings, where work occurs, will have safe, orderly
space. The facilities should be designed
and operated for preventing product mix-ups.
Regulating plant environments prevents deterioration of manufactured
products and allows control of materials.
Materials must be segregated, including cleaning agents and other
hazardous agents, to avoid corrupting end products. GMP requires receiving, storing, and handling
materials for resale in a manner preventing damage, mix-up, contamination, or
other adverse effects. GMP also requires
receipt and issue of materials for resale must follow procedures including
acceptance or rejection of the materials.
GMP requires that materials for resale must meet product specifications
and have records for traceability. GMP
requires securing customer owned materials, identifying, and controlling them
to prevent loss of identity.
GMP requires plant activities have clear, written, processing
specifications, procedures, and control limits.
These details help assure that products conform to the original design,
or specific authorized changes in the design, when the goods are shipped to the
end user.
Quality control and inspection equipment under GMP must be suitable for
the intended purpose and operated so they produce correct results. Records must document periodic equipment
calibrations as described in the quality assurance manual. GMP requires records showing results of
specific lots of material moving through critical steps in the process. These documents are important certificates of
compliance for the manufacturing plan.
Manufacturing novices often thing GMP requires tough and unproductive
steps. Their opinions change as losses
occur from ignoring the GMP lessons learned by experience. GMP insists on good, cost effective, process
control.
When you buy products from a facility with GMP, you have assurance the
products have high quality.
Good
manufacturing practice is:
Orderly and controlled manufacturing for doing things right the first
time. Professionally manufactured
products using GMP avoid surprises for the end user and have high quality. The pharmaceutical industry is the largest
user of GMP as a keystone of their quality program so that products are
manufactured without error—and you appreciate these carefully controlled steps
when your family needs health care. GMP helps us keep our jobs for the long run
and provides security for you and me.
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© Barringer & Associates, Inc. 1995