MACO Caluclation

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Hi,

I have product A, with maximum dose of 100mg and maximum batch size of 100kg. my next product “B” maximum dose is 30mg and batch size is 50kg. The general limit of the company is 10 ppm[Worst case]. calculate MACO value for B on A.

Please elaborate how to calculate.

If possible please give us methods to calculate MACO

Thanks in advance.

2

As the Company general Limit is 10 PPM then

0.001 percent of of Minimum batch size of next product

0.001 x 50, 000, 000 / 100 = 500 mg

MACO = 500 mg