I would like to ask everyone their opinion about critical quality attribute for granulation stage of a tablet and capsule product.
In particularly, I would like to know if you would consider uniformity of active or active content as a CQA at granulation stage. Based on that, do you believe uniformity of active or active content should be checked as part of process validation of a tablet or capsule product?
Also at the tableting stage, how do you decide on the frequency and number of tablets to be collected? Based on API % and the duration of tabletting? Can you please recommend any guidelines for this?
Thank you very much in advance