Cleaning validation through ADE approach, next we have to calculate MACO with or without SAFETY FACTOR, please conclude
ADe/PDE approach calculation for MACO does not required safety factor. Safety factor will come when you calculate MACO based on the dosag value.
In cleaning validation next batch will be considered based on over all product matrix or actual batch to next batch
We have 23 products, For suppose 4th number is to considered for cleaning validation and the 22nd product is my next batch. But as per the product matrix minimum batch size is 3rd number and Largest dose is 7th product. Pls conclude Maco
MACO= ADE(Previous batch-Cleaning validation product) X Minimum Batch size of next product
Largest Daily Dose of next product
So plz conclude next batch is nothing but overall or actual next batch???
By preparing ovarall cleaning matrix considering all products and their minimum batch sizes. The least MACO value you obtained shall considered.
If you are calculating MACO for only one stage where multiple products are not being executing, there you can consider the actual batch size of next product in the calculation.
1.what is the 10ppm criteria and what is the formula for 10 ppm criteria
2.MACO value is NMT 10ppm or 10ppm is only for SWAB and RINSE results
Which is the Recent updated cleaning validation guidelines