MAC is 0.1%, on what basis

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

For MAC calcutaions, two types are there. One is based on dosage and other is 0.1%. The 0.1% is recomanded by which guidline or regulatory?

2

Hi dear,

some guideline references are,

  1. Health canada, cleaning validation guidelines, point no. 10.4, page 9.
    [attach]162[/attach]
  2. HSA Singapore, Cleaning validation guidance note, point no. 11.3, page 9.
    [attach]163[/attach].
  3. FDA GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSES, page 7

Rationale is being given as 0.1% of maximum unknown impurity is accepted in the finished product as per regulatory.
Also the biological activity of drug was nil below 1/1000 (0.1%) of normal therapeutic dose of drug…

Regards
Satish Dange

Cleaning validation health canada 2008.pdf (92.3 KB)

GUIDE-MQA-008 Cleaning Validation.pdf (80.4 KB)