This is the query for the formula what we use to arrive the MAC value.
We use the formula based on Largest Daily Dose [ldd]. (ie).
MAC [in mg] = SF x J x SBS x1000000 x U
LDD x L
SF=safety factor, since oral solid dosage we use 1/1000 [0.001]
J= Smallest strength of Product A mfgd in the equipment train [in mg]
SBS = Smallest batch size of any other product , which is mfgd using the same equip train [in Kg][Product B1]
1000000 = for conversion of Kg to mg.
LDD= Largest Daily dose of any other product , which is mfgd using the same equip train [Avg wt x no of daily doses](ie Product B2]
U= Swabbed surface area in 4 sq.inch
L= Shared equipment contact surface area between A& B in sq. inch.
My query is to which approach [either 10ppm or Dose criteria] the above formula fits.???
If not so, pls describe any other parameters which I’m missing out in the above mentioned formula.