IQ OQ PQ PROTOCOLS.
Introduction the requirement..
This combined IQ OQ PQ
protocol was specifically designed to be used for stand-alone equipment. This combination protocol comprises of
three protocols which collectively have approximately thirty inspections or
tests that must be executed to verify that the equipment under qualification is
used, operates and performs in a manner that satisfies all the appropriate
requirements as detailed in the relevant User Requirements Specification (URS),
cGMP’s and your company practices and procedure rulings.
All companies carryout routine calendar
based qualification and requalification functional testing of stand-alone
laboratory type equipment.
Unfortunately most of this testing is documented in a manner that is not
compatible with basic FDA validation protocol standards. If a little time was spent on revamping
these test documents standards, (changing the template would only have to be
done once) a format could be used that would enable all such testing to be
included in any validation requirement.
Since regulators already accept the
concept that unnecessary retesting should be avoided whenever possible. It
follows that since all other tests in our protocols are fully written up, if the
routine functional testing was of the right format then a recently executed
routine or commissioning test could be reviewed and commented on in any
validation protocols, as an
alternative to repeating all the associated testing. This would result in the
time line and cost of validation for this equipment being greatly
Click here to view the FDA requirements for protocol
testing formats and wording.
Welcome to the home of IQ OQ PQ validation protocols.
on the appropriate link below for details of the iq oq pq protocol template you
Combined IQ-OQ-PQ Qualification.
for Writing SOP
do not want a template. If you
require a protocol bespoke to your requirement and ready to use, please click
Bespoke Ready to Use
document you want is not listed here please look in our document
The Bio-Med industries have documented regulations which are often
subjected to numerous interpretations.
Some of theses interpretations prove to be erroneous, some however, go on
to become acceptable practice and can eventually lead to the actual rules being
re-written or even abolished.
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its reader to share or seek advice about these interpretations and of course
problems in general. We will give
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IQ OQ PQ