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?
some guideline references are,
- Health canada, cleaning validation guidelines, point no. 10.4, page 9.
- HSA Singapore, Cleaning validation guidance note, point no. 11.3, page 9.
- 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…
GUIDE-MQA-008 Cleaning Validation.pdf (80.4 KB)