Dear All,

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

Where,

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.

With Regards,