Batch size increase without perfoming a process validation

Details:

HAVE A 100 KG BATCH SIZE OF ONE PRODUCT WITH PROCESS VALIDATION IN ONE PLANT.HOW MUCH BATCH SIZE I CAN INCREASE OR SCALE UP WITHOUT PROCESS VALIDATION IN SAME PLANT ( I HAVE A CAPACITY OF ALL EQUIPMENT IN SAME PLANT FOR INCREASE THE BATCH SIZE . ) CAN U GIVE ANY GUIDLINES FOR THAT. THANKS

	For your question there is no guidlines , But if your equipment have a capacity to increase the batch size then you can increase up to 150 kg but for regulatory purpose you have to do process validation

As per u r question with out process validation on temperory basis u can changate the batch size. but it is permenent basis u must be conduct the process validation.


rambabu
As per u r question with out process validation on temperory basis u can changate the batch size up to 20%. but it is permenent basis u must be conduct the process validation.

	Answered By: Rizwan Kazmi PhD |
	There is a SUPAC guide line for any change which is not similar to the validated batch with regards to material in the formula, equipment and process