Hello all,
Is there any requirement of Placebo batch process in Operational Qualification of Equipments? is there any Regulatory Requirements for the above?
Please clarify.
Usually placebo run use in OQ and PQ for actual product and money saving, Regulators don’t specify the placebo batches in qualification studies it depends on you.
There is no need for placebo runs during OQ. OQ only test functionality of your system.
It is good practice to perform a placebo run during PQ. This gives information on how all functionality integrates in a “known” proces. Difficulty is to put acceptance criteria on a placebo run. All requirements that are product dependent belong in product validation not in performance testing.
Rob
Dear Rob,
As per definition of OQ: Documented verification of the system or subsystem perform as intended over all anticipated operating range
In OQ , Tests should be designed to demonstrate satisfactory operation over the normal operation range as well as at the limits of its operation condition including worst case. (Refer :WHO-TRS-937-Annexure 4 section 11.9)
For instance, When the blender full capacity is challaenged during OQ, u can use placebo for blending at max load mass test. as well as some other tests, so functionalty test also perfom at process simulation. And second thing is that , in product validation there is no such items exist like IQ, OQ and PQ, in simple words, qualification for equipment and process validated.
.
In placebo run, the acceptance criteria is selected for basis of minimum %RSD, so there is no difficulty to put criteria, b/c it reveals more toward precision result instead of accurate.
please comments
yes dear ,
we need to do it .