Biomedical Engineering Reference
In-Depth Information
8.4 Qualifi cation considerations
Qualifi cation, in general, means fi tness for some purpose,
demonstrated by meeting necessary conditions or qualifying
criteria. In regulated industry, “qualifi cation” is used on the
one hand in a process sense and, on the other hand, in a
status sense. “Qualifi cation” can mean the process of
becoming qualifi ed. This is “qualifi cation” as a process,
for instance “the qualifi cation of the equipment on Line
28 is complete.” Closely associated with that usage is
“qualifi cation” as a status, as in “the hiring manager said
that the candidate had all the qualifi cations for the position.”
8.4.1 Qualifi cation process
Qualifi cation as a process can be applied to anything (e.g.,
equipment, instruments, facilities, and computer systems).
As Steven Ostrove states, “equipment, or systems, actually
used as part of the production process for the production or
manufacturing of a pharmaceutical or medical device
product must be qualifi ed prior to its use.” It can also be
applied to personnel. Ostrove goes on to acknowledge that
“the term 'Qualifi cation' appears twice in Title 21 of the
CFR: 21 CFR 211.25 - Personnel qualifi cations (and)
21 CFR 211.34 - Consultants.”
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According to the well-
accepted approach to equipment qualifi cation, there are
three main phases to the qualifi cation process: Installation
qualifi cation (IQ), operational qualifi cation (OQ),
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and
performance qualifi cation (PQ).
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These three phases - IQ/OQ/PQ - can also usefully be
applied to the process of qualifi cation of personnel, as follows:
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Personnel IQ may be likened to providing objective
evidence that the prospective trainee have the requisite
