Biomedical Engineering Reference
In-Depth Information
10. See International Conference on Harmonisation (ICH)
(2005).
11. See G.R. Kermode and S. Sivaloganathan (2000).
12. See 42 CFR 493.17. For an overview of CLIA, see
Patrick Rivers
et al
. (2005).
13. See ICH (2005) op cit.
14. See Roger Nosal and Tom Schultz (2008), writing on
behalf of the Product Quality Life-cycle Implementation
(PQLI) initiative of the International Society for
Pharmaceutical Engineering (ISPE); also Thomas Garcia
et al.
(2008). As Matthew Ferrier (2006) has defi ned it,
a critical component of a process is “a component
within a system where the operation, contact, data,
control, alarm, or failure will have a direct impact on
the quality of the product,” while a non-critical
component is “a component within a system where the
operation, contact, data, control, alarm, or failure will
have an indirect impact, or no impact on the quality of
the product.” We can interpret “quality” in this context
to mean the SISPQ of the product.
15. See also Roger Nosal and Tom Schultz (2008), op. cit.
David Fetterolf (2007) has provided an illustration of
the measurement of criticality, where each parameter of
a system is assessed for its potential to affect the
applicable process controls or quality attributes. Each
parameter is given a numerical rating based on the
likelihood and potential magnitude of impact. The
parameters that have the highest likelihood and
potential to affect the process are entered into range-
fi nding studies and the outcome of the studies is the
relationship between the parameter's normal
operating
range
(r
o
, control space) and its proven
acceptable
range
(r
a
, design space). The normal operating range is
the range at which the parameter is typically controlled
