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Good Manufacturing Practice (GMP) |
Good Manufacturing Practice is 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 Authorisation
or product specification.
Good
Manufacturing Practice is concerned with both production and quality control.
The basic requirements of GMP are that:
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all
manufacturing processes are clearly defined, systematically reviewed in the
light of experience and shown to be capable of consistently manufacturing
medicinal products of the required quality and complying with their
specifications; |
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critical
steps of manufacturing processes and significant changes to the process are
validated; |
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all necessary
facilities for GMP are provided including:
a.
appropriately qualified and trained personnel;
b.
adequate premises and space;
c.
suitable equipment and services;
d.
correct materials, containers and labels;
e.
approved procedures and instructions;
f.
suitable storage and transport;
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instructions
and procedures are written in an instructional form in clear and unambiguous
language, specifically applicable to the facilities provided; |
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operators are
trained to carry out procedures correctly; |
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records
are made, manually and/or by recording instruments, during manufacture which
demonstrate that all the steps required by the defined procedures and
instructions were in fact taken and that the quantity and quality of the
product was as expected. Any significant deviations are fully recorded and
investigated; |
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records of
manufacture including distribution which enable the complete history of a
batch to be traced, are retained in a comprehensible and accessible form; |
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the
distribution (wholesaling) of the products minimises any risk to their
quality; |
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a
system is available to recall any batch of product, from sale or supply; |
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complaints
about marketed products are examined, the causes of quality defects
investigated and appropriate measures taken in respect of the defective
products and to prevent reoccurrence. |
Quality
Control
Quality Control
is that part of Good Manufacturing Practice which is concerned with sampling,
specifications and testing, and with the organisation, documentation and release
procedures which ensure that the necessary and relevant tests are actually
carried out and that materials are not released for use, nor products released
for sale or supply, until their quality has been judged to be satisfactory.
The basic
requirements of Quality Control are that:
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adequate
facilities, trained personnel and approved procedures are available for
sampling, inspecting and testing starting materials, packaging materials,
intermediate, bulk, and finished products, and where appropriate for
monitoring environmental conditions for GMP purposes; |
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samples of
starting materials, packaging materials, intermediate products, bulk products
and finished products are taken by personnel and by methods approved by
Quality Control; |
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test methods
are validated; |
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records are
made, manually and/or by recording instruments, which demonstrate that all the
required sampling, inspecting and testing procedures were actually carried
out. Any deviations are fully recorded and investigated; |
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the finished
products contain active ingredients complying with the qualitative and
quantitative composition of the Marketing Authorisation, are of the purity
required, and are enclosed within their proper containers and correctly
labelled; |
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records are
made of the results of inspection and that testing of materials, intermediate,
bulk, and finished products is formally assessed against specification.
Product assessment includes a review and evaluation of relevant production
documentation and an assessment of deviations from specified procedures; |
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no batch of
product is released for sale or supply prior to certification by a Qualified
Person that it is in accordance with the requirements of the Marketing
Authorisation; |
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sufficient
reference samples of starting materials and products are retained to permit
future examination of the product if necessary and that the product is
retained in its final pack unless exceptionally large packs are produced. |
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