Process validation

Dear All,

If we have 2 granulation suits and both the granulation equipment’s are similar in shape, identical, same make and same capacity…

But having different model Number,
(Means: Not exactly same technical specification, but somehow comparable specs.)

As, of now granulation-1 is under major maintenance and production need to take batch one granulation-2, which is not validated before for the particular products.

So, what can be a good strategy of process validation…!

Shall i proceed with:
1.Risk assessment and a process verification batch in granulation-2.
2.Comparative study of blend in both granulation.
3. Comparative Disso. profiling
4. Sample shall be taken for Ongoing stability study, for monitor the impact ifany?

will suffice the regulatory requirement?

Or need to take 3 batches !!

If have not same make and model we take 3 batches for validation.

1 Like

In my opinion, option 1&4 are sufficient. As per current guidelines on process validation, if we can justify with sound scientific reason, even one batch is sufficient to give evidence for proving the process equivalency


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