I need articles related to Cleaning Validation.
- MACO calculation based on 10 ppm criteria.
- Worst case study for multiple products.
- MACO calculation based on dose criteria.
- Calculation for hold time study dirty and cleaned equipments.
Thanks & Regards,
For your request 1- 4, i would like to refer you to the following text book;
Validation of Active Pharmaceutical Ingredients, SECOND EDITION, edited by Ira R. Berry and Daniel Harpaz, CRC Press.website