Repackaging really should be done under proper environmental circumstances to stay away from contamination and cross-contamination.___________________________________________________________________________________________________________________________________________________________________________________________________________________________

You will also desire to reference all info collected over the PQ, prepare a summary of conclusions drawn, condition if the predicted effects were realized, and specify any comply with-up activities you plan to correct deviations.It doesn't include the specific requirements of 21 CFR Aspect eleven, except for the prerequisite that devices be validat