PRINCIPLE
The Good Manufacturing Practices for
pharmaceutical products is aimed to ensure that products are consistently
manufactured to meet specified quality appropriate to their intended use. It is
concerned with all aspects of production and quality control.
GENERAL
In the manufacture of pharmaceutical
products, overall control is essential to ensure that consumers receive
products of high quality. Haphazard operations cannot be tolerated in the
manufacture of products intended to save life or to restore or to preserve
health.
It is not sufficient that the
finished product passes testing protocols, but quality must be built into the
product. The quality of pharmaceutical products depends on the quality of starting
materials and packaging materials, production and quality control processes,
building, equipment and personnel involved.
Sole reliance should not be placed
on any test for assurance of quality. All products should be manufactured under
carefully controlled and monitored conditions.
The good practices given hereunder
should be considered as guidelines with the objective of ensuring that the
products are of the nature and quality intended; wherever necessary, they may
be adapted to meet individual needs, provided that established standards of
product quality are still achieved.
Administrative measures of Drug
Regulatory Authority (DRA) should be directed towards the application of these
standards in practice, and any new or amended national regulations for good
manufacturing practice should at least meet their level.
These standards are also intended to
serve manufacturers as basis for elaboration of specific rules adapted to their
individual needs.
In addition to general matters of
Good Manufacturing Practices outlined in the chapters of this Guide,
supplementary guidelines have been incorporated. The purpose of the
supplementary guidelines on other subjects is to provide details about specific
areas of activity which may not necessary apply to all manufacturers.
Herein apply to medicines and
similar the standards set out products intended for human use.
It is recognized that there are
acceptable methods, other than those describes in this Guide, which are capable
of achieving the principle of the Guide. This Guide is
not intended to place any restraint upon the development of new concepts
or new technologies, which have been validated and provide a level of Quality
Assurance at least equivalent to those set out in this Guide.
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