The basic requirements for quality
control are as follows:
(a)
adequate facilities, trained personnel and
approved procedures must be available for sampling, inspecting, and testing starting
materials, packaging materials, and intermediate, bulk, and finished products,
and where appropriate for monitoring environmental conditions for GMP purposes;
(b)
samples of starting materials, packaging
materials, intermediate products, bulk products and finished products
must be taken by methods and personnel approved of by the quality control
department;
(c)
qualifications and validation must be
performed;
(d)
records must be made (manually and/or by
recording instruments) demonstrating that all the required sampling, inspecting and testing
procedures have actually been carried out and that any deviations have
been fully recorded and investigated;
(e)
the finished products must contain ingredients
complying with the qualitative and quantitative composition of the product
described in the marketing authorization; the ingredients must be of the
required purity, in their proper container and correctly labeled;
(f)
records must be made of the results of inspecting and testing the
materials and intermediate, bulk and finished products against specifications;
product assessment must include a review and evaluation of the relevant
production documentation and an assessment of deviations from specified
procedures;
(g)
No batch of
product is to be released for sale or supply prior to certification by the
authorized person(s) that it is in accordance with the requirements of the
marketing authorization. In certain countries, by law, the batch release is a
task of the authorized person from production together with the authorized
person from quality control;
( h)
Sufficient samples of starting materials and
products must be retained to permit future examination of the product if
necessary; the retained product must be kept in its final pack unless the pack
is exceptionally large.
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