IQ OQ PQ PROTOCOLS.
Introduction to 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 any individual IQ, OQ OR PQ protocol template you require.
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
Benifits of Using Tripartite Format.
All our 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.
So what do I save in using these three part
One introduction to be edited. One rationale to be edited. Test scripts all written up for
you. One document to be circulated
for review. One document to be
edited - post review -.
Only one document to be managed and
maintained through from conception to execution and through change control and
on to archived.
Consider 10 items requiring validation
that means it could be just 10 protocols as opposed to 30 to write, review, edit
and approve. Make no mistake; reviewing and approving documents is always the
task that is least planned for and subsequently often a serious bottle neck in
achieving time line requirements.
editing is interactive, i.e. entering the basic data once (Company
name/equipment details, etc.) immediately inserts the entered data throughout
the whole document.
IQ OQ PQ