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such things as user manuals, site requirement documents, etc. Dynamic documents
are generated during the OQ and PQ phases, when actual instrument testing takes
place. These documents provide a running record of the instrument's use and main-
tenance, and should be kept in a system log book with the instrument, available for
viewing as necessary by anyone interested (i.e., the FDA). These documents should
also be appropriately archived for future reference and protection.
2.7 Instrument cAtegorIes
Analysts in the regulated laboratory apply a wide range and complexity of instru-
mentation in their everyday tasks, from balances to mass spectrometers, and the level
of complexity dictates the level of qualification. Recognizing the differences, the
USP categorized instruments into three groups: A, B, and C. More information on
the three categories as they are broken down in the USP, along with some examples
and approaches, are outlined in Table 2.7.
Conformance of Group A instruments (the lowest level of qualification) with user
requirements is determined by visual observation; no independent qualification pro-
cess is required. Examples of Group A instruments include spatulas, ovens, mag-
netic stirrers, microscopes, and vortex mixers.
The conformance of Group B instruments with user requirements is determined
according to the instruments' SOP, and their failure is usually readily discernible.
Examples of instruments that fall into this category are pH meters, balances, ther-
mometers, refrigerator/freezers, and vacuum ovens.
Group C instruments are defined as highly method-specific, complex instru-
ments with conformance determined by their application. Full qualification is
tAble 2.7
usp Qualification criteria and Approaches
category
usp classification criteria
usp Qualification Approach
examples
A
Standard equipment
No measurement capability
No calibration requirement
Specifications set at
manufacturer
Conformance with specifications
verified and documented by
observation during operation
Centrifuges
Sonicators
Magnetic stirrers
B
Standard instruments with
measurable output or that
control physical parameters
User-specified requirements
Calibration required
Conformance to specifications/
requirements specified in SOPs
and IQ/OQ
pH meters
Thermometers
Pumps
Ovens
Balances
Water baths
C
Complex instruments and
computerized systems
Full qualification required
specific performance and
functions tests
HPLC
GC
Spectrometers
(UV, AA)
Dissolution baths
