May i know if i have a production of batch sizes ranged over 50L - 500L. Everything similar for min and max batches (eg. equipments, manufacturing process and etc.). How many batches that i need to validate for the minimum and maximum batches? Can i just validate
a) 1 batch of 50L, 1 batch of 500L and 1 batch of intermediate batch size for example 250L or
b) 3 x min (50 L) and 3 x max batch size (500L) or
c) 2 x min (50L) and 2 x max batch size (500L) ?
Any guideline supports the feedback/reply?
[quote=ajlc]May i know if i have a production of batch sizes ranged over 50L - 500L. Everything similar for min and max batches (eg. equipments, manufacturing process and etc.). How many batches that i need to validate for the minimum and maximum batches? Can i just validate
a) 1 batch of 50L, 1 batch of 500L and 1 batch of intermediate batch size for example 250L or
b) 3 x min (50 L) and 3 x max batch size (500L) or
c) 2 x min (50L) and 2 x max batch size (500L) ?
Any guideline supports the feedback/reply?
Thanks.[/quote]
assuming equipment gets dirtier with larger batch? in that case, why not just sample following 3 large batches. this would be ‘worst case’ and smaller batches automatically covered
FDA’s “Guidance for process validation; General principles & practices” provides guidance for process validation, no longer consider the traditional three batches validation appropriate but also does not prescribe no. of batches to validate or suggest any method to determine it.
Generally it is considered if we get desired quality in first batch, it is accidental, second batch quality is regulator, and quality in third batch is validation.
If two batches are taken as validation the data will not be sufficient for evaluation and prove reproducibility because statistical evaluation can not be done on two points, it need minimum three points because two points always a straight line. Therefore , minimum three batches are evaluated for validation of manufacturing process and cleaning procedure. three batches may be taken in validation but it involves cost and time and the companies does not want to do so.
Dr. Pradeep Nagalkar