i have a doubt on calculation of MACo.
one of the guideline says that 10ppm criteria can be used. As the rule is that not more than 10ppm of the previous product should be present in the largest daily dose of the next product i use this instead of cumbersome formulas.
i have different batch sizes and i will be taking the least bacth size and the formula of MACO = 10 x least batch size in kg. = y mg
Now my MACO is this. Can i use this formula for calcualting? instead of cumbersome formulas? and obviously i am meeting the criteria. can i have a feedback. or else do we need anyother calculation. i wanna know a sound formula which has no loopholes so that tomorrow no one can question. though its a debatable point some say that their formula is correct and it goes on. So ultimately the MACO obtained by one company for the same set of products will not match the others and thus lot of variance.
so i request you all to give me feedback on this and how does the regulatory authorities view it. suggest me such that there will be no more drawbacks in that formula.
so what is correct please guide me.
and moreover the general practice of collecting swab is from an area of 4x4 etc. if the critical area included in sampling is the shaft of chopper in RMG or the inner wall of multimill blade etc then on what basis is the formula claculate?