1. We did such cGMP transfers to our QC and to contract manufacturers' QC several times a year.
2. Unfortunately, I cannot remember what our agreement values were for agreement to R&D values, or where the values came from.
Obviously, results had to meet cGMP system suitability criteria. This held for EACH OPERATOR at these locations. We supplied three samples previously assayed at R&D; each sample would be prepared from scratch three times, and each prepared sample was injected at least twice.
I think we used 98 – 102% agreement and standard deviation of 2 for each of the nine samples.