Biomedical Engineering Reference
In-Depth Information
PROCESS DEVELOPMENT
AND CLINICAL PRODUCT
MANUFACTURING
The Use of Risk Management Tools in Development
of Investigational Medicinal Products
KAREN S. GINSBURY
6.1 QUALITY VISION OF PHARMACEUTICAL DEVELOPMENT
One definition of a product is any thing/item that can be offered to a market
in order to satisfy a potential want or need. For a clinical product, intended for
use in human trials, the want or need is related to sickness/disease/pathology
and therefore specifically to a
patient's
want or need. Therefore, the first quality
attribute of any clinical product is that it must be developed to potentially satisfy
some patient's want or need.
A product starts out as an idea or concept, which is carried forward, hopefully
to realization, by following a set of processes. It is noteworthy that for pharma-
ceutical products the success rate for commercial product realization is low and
the process is long. However, clinical trial materials are also a form of realized
product and they are brought to the patient much earlier in the overall product
life cycle. Product realization can be defined as
“The sum total of all the processes that are used to bring a product into being”
and involves starting with raw materials and working them into the defined finished
product.
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