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cGMP
Systems supplies standards in the form
of its Guidelines for over 50
types of equipment and system (see
list of types).
A
Guideline defines the standardized
testing methodology for the validation
of an equipment type. Each Guideline
contains both high-level and detailed
information:
A
high-level educational overview:
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A
description, in general terms,
of the equipment or system type,
how it works and what the scope
of the guideline will cover. The
guideline then identifies the
recommended IQ, OQ and PQ test
procedures (which together
represent the prescribed
qualification methodology).
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A
general discussion of each test
procedure, including why the
test is important and how the
test is applied, as well as any
unique features of the test as
they relate to the specific
system.
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References
to the appropriate
U.S.
and International regulatory
guidance documents, as well as
other industry-related materials
and articles that could be of
use to the reader.
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Detailed
test procedures:
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For
each test recommended in the
guideline, an associated
detailed test procedure,
containing the actual text that
is used in the protocol: it
describes the steps to follow to
perform the test, as well as an
area to define the acceptance
criteria. Each test
procedure also has one or more
data sheets for recording
expected and actual test
results. Guidelines contain an
average of 20 tests; the largest
contains almost 40. |
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These
detailed test procedures and
data sheets (which are specific
to a type of equipment or
system) can be assembled into a
draft protocol that needs only
editing to reflect the details
of the model to be validated. |
Guidelines
are provided in Microsoft Word form, and
the included test procedures can readily
be inserted into your company’s
standard protocol templates. You
can modify Guidelines (for example,
tests can be added, deleted or revised)
to suit your particular company
requirements and standards.
Click
here to view a summary of Guideline
benefits
Click
here to download the Guidelines Brochure |
