Manufacturers of medicinal products must comply with the requirements of their marketing authorization (product licence) and ensure that their products are fit for their intended use in terms of safety, quality and efficacy.
QUALITY
ASSURANCE AND THE
CONTROL OF MICROBIAL RISK
IN MEDICINES
Manufacturers of
medicinal products must comply with the requirements of their marketing authorization (product licence) and ensure that their products
are fit for their
intended use in terms of safety, quality
and efficacy. A quality
management system (QMS)
must therefore be in place so that senior management can ensure that the required quality
objectives are met through a comprehensively designed and properly implemented system of quality assurance (QA), encompassing both GPMP and quality control (QC).
QA encompasses,
in turn, a scheme of management
which embraces all the
procedures necessary to provide a high probability that a medicine will
conform consistently to a specified description of quality.
It includes formulation design and development (R&D), GPMP, as well as
QC and post-marketing surveillance. As many
microorganisms may
be hazardous to patients or cause spoilage of formulations under suitable
conditions, it is necessary
to perform
a risk assessment of contamination for each product. At each stage
of its anticipated life from raw materials to administration, a risk assessment should be made and
strategies should be developed and calculated
to reduce the overall risk(s)
to acceptably low levels. Such risk assessments are complicated by uncertainties about the exact infective and spoilage hazards
likely for many contaminants,
and by difficulties in measuring their precise performance in complex systems. As the consequences of product failure
and patient harm
will inevitably be severe, it is usual
for manufacturing companies to make
worst-case presumptions and design strategies to cover them fully; lesser problems are also then encompassed. As it must
be assumed that
all microorganisms may be potentially hazardous for those routes
of administration where
the likelihood of infection from
contaminants is high,
then medicines to be given
via these routes must be supplied
in a sterile form, as is the case with injectable products. It must also be presumed
that those administering
medicines may not
necessarily be highly skilled or motivated
in contamination control
techniques; additional safeguards to control risks may be included in these situations. This may include
detailed information on administration as well as training, in addition to providing a high quality formulation.
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