Hi,
Could someone list acceptance criteria for performance qualification of a labeling machine in pharmaceutical industry.And on what references or guidelines are acceptance criteria based?
No references or guidance docs that I know of. PQ is more or less “did it work for extended periods” rather than any particular acceptance criteria. Depending on your situation, this may involve a variety of label types / sizes, content, etc. The number and duration of runs is something you’ll have to justify as being sufficient. Things to consider when assessing if it worked was if printing maintained the same quality throughout, did any printing drift off of the label over the run, was correctness maintained across label stock / ink replenish, were labels properly applied throughout the runs, etc.