If maco value is less than the LOQ,then can we kepp the LOQ value as maco.or not.if not then why…?
MACO is maximum allowable in next batch which is calculated minimum value by toxicity or tdd or 10ppm criteria. And LOD or LOQ are represents capability of your analytical method. If MACO is lower than LOQ; then your cleaning analytical method will not give correct result due to its un-capability. You are allowing contamination more than MACO requirement which is not acceptable.
You may use the ADE (acceptable daily exposure, a measure of toxicity) to calculate your ‘cleaning validation acceptance criteria’. Perform a ‘risk analysis’ to target the lowest. Then determine which cleaning procedure is effective using the target as the ‘yardstick’.
Cite chapter 3 and 5 of the Eudralex.
1-what is the basic difference between dose criteria & PPM criteria ?
2-what is the difference between maco & ADE (acceptable daily exposure, a measure of toxicity).
As per APIC cleaning validation guide, If the limit which is calculated for Swab and Rinse are below LOD or LOQ, then LOD or LOQ has to be considered as limits for Rinse/Swab and the obtained result of cleaned sample should be Not detected for the Limit LOD and for the limit LOQ result should be BLQ. It means cleaning shall be continued up to not detected level.