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Available - COMBINED IQ/OQ/PQ - Protocols.
Available - AUTOCLAVE VALIDATION - protocols.
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IQ/OQ/PQ Protocols Introduction.
three part combined IQ/OQ/PQ protocols are written to a common standard with the
layout, introduction and table of contents being very similar. While all the test and inspection stages
are purposely targeted at the validation requirements of the specific item under
qualification. The IQ
section contains all the standard inspections and tests that you would include
in a stand-alone IQ for the same equipment. The OQ section in a similar manner
contains all the standard tests and inspections that are usually included in a
stand-alone OQ protocol and the PQ follows the same pattern. All three sections contain spare test
script pages; that can easily be edited to suit any specific additional tests
that may be required.
do I save in using these three part protocols?
You have the flexibility to edit
each section as you deem necessary. I.E. even although the IQ has
many tests and inspections in it; you may decide that the item under
qualification only requires minimal IQ attention; perhaps just registration and
document verification. Once you have decided;
then you simply edit it down to your
requirements. The main thing from the regulatory point of view
is; there is an IQ in place and you have a justification for its contents.
This justification can be and normally is; contained in the
VP. However it can be written into the introduction section
of the combined IQ/OQ/PQ protocol.
One document instead of three -
just has to be an interesting offer. There is always instances where one
of the three documents (IQ or OQ or PQ) has little or no content. I.E what
is the IQ content for a critical portable test instrument? What is
the OQ content for a critical feed shut? Finally what is the PQ content for a
critical holding tank? Even ignoring these questions; one of the most time
consuming; but nearly always overlooked tasks, is the reviewing and approving of protocols. If you can cut that task by 66% then it must be a big plus.
Combined IQ/OQ/PQ Protocols.