Re: Dose Consistency of Insulin Formulations ...
If you are not looking for specific methods & numbers ... let try to put my understanding forward......(typically what we do in validation procotols in similar context)
Protocol/study plan :-
a) identify the range of device characteristics (basically batch to batch variation of its accuracy, precision etc.,)
b) identify the range of product characteristics which device has to handle... ( different levels of pH, viscisity, assay, CU or any other relevant/specific parameter )
c) arrive at an test-method(sequence viz., device operating conditions, settings, ) and acceptance criteria (of accuracy and precision.... )
b) & c) are usually an extension(matrix) of product requirements and device performance capabilities.(as selected by you or as stated by vendor)
while execution/implementing the protocol ...
* first characterize the batch at the required levels as identified above
* execute the experiment.
* analyze the data.
*conclude (addressing the recommendations, / deviations etc)
hope this helps.
further,
We have already established consistency between different batches of the formulation. So I assume we have validated our process. Please correct me if I am wrong
yes, your formulation is consistent not the product/process!!!
for us product is formulation+device; hence consistency of formulation alone wouldn't really be complete w/o addressing rest of the part as well.!!!