Dear Members
The question is about Cleaning Validation.
The scenario is as follows. In a multi product Tablet manufacturing facility, A product matrixing has been done and there are product grouped into worst case as per thier phys-chemical properties
1). In the worst case product matrix group, Product ‘X’ is the worst case as per the cleanability and solubility calculation.
2). Product ‘Y’ is in the same product worst case matrix.
3). Both the product use common equipment for dispensing or sieving.
4). Campaign length extension production for Cleaning Validation , of shared equipments has been executed for Product ‘X’, which contains only 10 kg of Active ingredient. (for 10 Batches).
This allows 100 Kg of Active ingredient Processing in dispensing equipment before cleaning is performed.
5) Product Y has 200 KGs of Active in a single batch. which doesnot allow the product Y to be processed beyond a single batch i.e Cleaning has to be performed after every batch.
6) So do we need to perform separate cleaning validation studies for product X and Y ?
7) Is there any other justification to have a single cleaning validation study which covers for both the product processing , for campaign length extension., as both the product are in same worst case grouping as per Matrix?