GMP
is defined That
part of Quality Assurance which ensures that products are consistently produced
and controlled to the quality standards appropriate to their intended use and
as required by the Marketing Authorization or product specification.
Quality
Assurance is defined as:
The
sum total of the organized arrangements made with the object of ensuring that
medicinal products are of the quality required for their intended use.
The
formal definition of Quality is:
The
totality of features and characteristics of a product or service which bear on
its ability to meet stated or implied needs.
Quality
Control is the process by which we measure actual quality performance, compare
it with a standard and take action if there are any differences. This process
of comparison takes place during the production stages and when the product is
ready for delivery. At this point we can use the product specification to
compare with, at earlier stages there may need to be intermediate
specifications.
One
of the basic principles of GMP, which is echoed in ISO 9000, is for the responsibility
for Quality Control to be held by somebody independent from the people
responsible for production. This does not mean that the testing facilities need
to be managed independently, but that the acceptance of the results of the
testing must be independent, as must the initiation of any actions necessary
after examining the results.
GMP REQUIREMENTS
The
current version of “Rules and Guidance for Pharmaceutical Manufacturers and Distributors”
has nine chapters, which have the following titles:
1.
Quality Management
2.
Personnel
3.
Premises and Equipment
4.
Documentation
5.
Production
6.
Quality Control
7.
Contract Manufacture and Analysis
8.
Complaints and Product Recall
9. Self Inspection
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