IQ-OQ-PQ Protocols Introduction.

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 of all the templates contain spare test script pages; these templates can easily be edited to suit any specific additional tests that may be required.  So what do I save in using these three part protocol templates?

You have the flexibility to edit each template section as you deem necessary.  I.E. even although the IQ has many tests and inspections in it; once the execution of the Validation Risk Assessment (VRA) has set the scope for the protocols, you will be able to edit your protocols accordingly. The main thing from the regulatory point of view is; there is an IQ in place and you have a documented 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 protocols.