Chemistry Reference
In-Depth Information
validation process using trained, qualified personnel begins with validated software
and a validated/qualified system; then a method is developed and validated using the
qualified system. Finally, the whole process is wrapped together using system suit-
ability. Each step is critical to the overall success of the process.
1.6.1 S
oftwAre
v
AlIdAtIon
A comprehensive treatment of software validation is outside the scope of this vol-
ume. However, it is an important topic to at least touch upon here as these days
every modern laboratory makes use of computerized systems to generate and main-
tain source data and documentation from a variety of instrumentation. These data
must meet the same fundamental elements of data quality (e.g., attributable, leg-
ible, contemporaneous, original, and accurate) that are expected of paper records
and must comply with all applicable statutory and regulatory requirements. Two
FDA guidelines have appeared recently that address the topic of software valida-
tion, and should be consulted for more detailed information [15,16]. In addition, in
March 1997, the FDA issued 21 CFR Part 11, which provided the original criteria
for acceptance of electronic records, electronic signatures, and handwritten signa-
tures executed to electronic records as equivalent to paper records and handwritten
signatures executed on paper under certain circumstances [17]. However, after the
effective date of 21 CFR Part 11, significant concerns regarding the interpretation
and implementation of Part 11 were raised by both FDA and the pharmaceutical
industry and, as a result, 21 CFR Part 11 was reexamined [18]. The new Scope and
Application Guidance clarified that the FDA intends to interpret the scope of Part 11
narrowly and to exercise enforcement discretion with regard to Part 11 requirements
for validation, audit trails, record retention, and record copying. However, most of
the other original Part 11 provisions remain in effect.
1.6.2 A
nAlytIcAl
I
nStrument
Q
uAlIfIcAtIon
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 sys-
tem performance prior to the instrument being placed on-line in a regulated environ-
ment. 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” [19]. Among other objectives, the
various parties (the event drew a cross-section of attendees; users, quality assurance
specialists, regulatory scientists, consultants, and vendors) agreed that processes 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
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 [20-22]. The
chapter details the AIQ process, data quality, roles and responsibilities, software
