Is it allowed to compress one batch on 2 different machine and why it is not allowed?
It may be not complete the machine equivalency parameter
the main question is that why u want to compress on 2 different machines?
Even if you have proven that both machines are equivalent, for traceability purposes it is not advisable. In case of deviation or complaint/recall, you would have an issue determining what part of the batch was produced on what machine. Why not create two batch numbers for batches produced on two machines, even when using the same batch of granulate?
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It is one batch but he’s it compressed on the first machine it stopped suddenly which led us to complete compression on the 2nd one
It is acceptable?
if machine has sam make n model then can b compressed.
Validation of the product also we have to look on both machines. If one is validated or one not how we can compress in other machine
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if all specifications make n model of equipment is same then validation is not req for both,its performed on 1
I disagree, you still need to verify that the second machine creates tablets that comply to the same specs as the first machine. This is too critical to be treated as a like-for-like!
To come back to the original question, I think you should still create two different batch numbers.
Dear Mr. Sajjad,
Assessment should be done with respect to process all critical process parameters, equivalency certificate to attach as per Assessment No, of batches to be selected or at least one verification batch need to be taken to ensure there is no impact.
Thanks