Chemistry Reference
In-Depth Information
2
Analytical Instrument
Qualification
2.1 IntroductIon
In the most general sense, validation refers to a process that consists of at least
four distinct components or steps: software, instruments, methods or procedures,
and system suitability [1-8]. The system, the software, and the method must all be
validated, and system suitability is used to keep the process in check. But while the
overall process is called
validation
, some of the steps are also referred to by that
same term, as well as others—for example,
qualiication
and
verification.
. Prior to
undertaking the task of method validation, it is necessary to invest some time and
energy up-front to ensure that the analytical system itself is validated, or
“qualified,”
.
Qualification is a subset of the validation process that verifies proper module and
system performance prior to the instrument being placed on-line in a regulated
environment.
In March 2003, the American Association of Pharmaceutical Scientists (AAPS),
the International Pharmaceutical Federation (FIP), and the International Society for
Pharmaceutical Engineering (ISPE) co-sponsored a workshop entitled “A Scientific
Approach to Analytical Instrument Validation” [9]. Among other objectives, the
various parties (the event drew a cross-section of attendees; users, quality assur-
ance specialists, regulatory scientists, consultants, and vendors) agreed that pro-
cesses are “validated” and instruments are “qualified,” finally reserving the term
validation
for processes that include analytical methods/procedures and software
development.
The proceedings
of the AAPS et al. committee
were originally published as a
position paper and
also appeared in USP's Pharmacopeial Forum [9]. These pro-
ceedings have now become the basis for a new
general USP chapter, number 1058,
on Analytical Instrument Qualification (AIQ) that originally appeared in the USP's
Pharmacopeial Forum [10]. The chapter details the AIQ process, data quality, roles
and responsibilities, software validation, documentation, and instrument catego-
ries. In addition, because high-performance liquid chromatography (HPLC) is the
predominant analytical technique used in the regulated laboratory today, specific
examples related to qualifying an HPLC instrument will be discussed.
2.2
components oF dAtA QuAlIty
The goal of any regulated laboratory is to provide reliable and valid data suitable
for its intended purpose. Analysts use validated methods, system suitability tests,
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