can anyone please undertsand me the rational behind 3 replicates in validationcycles. is it any mathematically proved or any othe phylosophy
This was an old “rule of thumb” for process validation. The number of lots needed was never specified. Three lots was generally used to demonstrate reproducibility. However, with the 2011 revisions to the process validation guidelines, the FDA is looking at a life-cycle approach.
I would suggest reading the article that this site just put out:
http://www.askaboutvalidation.com/54274-process-validation-1987-vs-2011-what-you-need-to-know