cleaning validation Contribution from Ilyas Patel written on 11/27/2006 at 12:42
This is regarding cleaning validation.
We are manufacturing different API products on campaign basis. All products have different batch sizes. For MACO calculation and to establish limit for each piece of equipment should we require
1. To consider the smallest batch size and max. daily dose amongst all the products or
2. should it be calculated product wise i.e. smallest batch size and max. daily dose for each product separately.
In case no. 1 the limits of all the products are changed everytime when any new product is inserted or any of the batch size is changed.
regards and thanks in advance for the advice Answers to this contribution:
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