Process Validation using different lots of API

dear all,
good day. hope you all are well.

please help me on following issue.

is there any criteria or regulation regarding process validation that the validation batches (3 batch) to be manufactured using same lots of API. or different lots can be used as well.
please help me with reference.

thank you in advance.


There is no specific regulation for this. You may use different lots of APIs in the Process validation 3 batches. Please ensure that the API is having same QC specification for testing and all the lots must be manufactured by the same company (Same vendor source).

1 Like

thank you. yeah. right .
i think using different lots of same source will make the process validation more robust.

thank you again.

Yes, absolutely.

Thank you so much

You are always welcome.

Can we validate batch of two different vendor of same API in 3 validation batches ?

No, please.