We are having a multi product facility and one of the product TDD not known, So we are calculated the MACO value as per LD50, But carry over of the product attained below LOD value as per cleaning method validation. So the cleaning method is not capable to detect the carryover limit. So how we calculate the carryover, we shall go with general limit calculation?
In the APIC guideline general limit chapter explains as follows:
“If the calculation methods based on therapeutic doses or toxicological data result in unacceptably high or irrelevant carryover figures, or toxicological data for intermediates are not known, the approach of a general limit may be suitable”.
As per general limit calculation we got the carry over value above detection limit, Shall we consider the clause and calculate as per general limit? Or any alternatives availble to conclude the problem. pls suggest.