Process Validation

Quality Assurance
1

we have 2 batch of 105 kg & one batch 50 kg.
Can we consider 50 kg as the third batch for validation if the manufacturing process, equipment, and filling machine are all the same for both 105 kg and 50 kg batches. Is separate validation required?
Note: We do not have any further orders for that product so how to close please guide us.

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2

To prove the consistency and repeatability of the manufacturing process, need to perform minimum 03 batches with same conditions without any changes towards R.M quantities/ batch size/ manufacturing process etc


General criteria for process revalidation shall be change in batch size, change in manufacturing process, change in equipment etc


In your case, If you want to change the batch size then it also needs to be validated.

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3

Thanks for your valuable response.
105 kg protocol is applicable for 50 kg batch size if all parameter same.
Or separate annex to this protocol is required.

4

We can’t conclude the consistency, repeatability of the manufacturing process and not possible to prove statistically by changing the batch size. So, you need to prepare separate protocol
by mentioning the reason in scope.

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5

thank you

6

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