API Manufacturing: The acceptance limits of 10 ppm or 0.1% of daily dose (final API, dryers, etc.), and of 1000 ppm (intermediates), for cleaning are ubiquituous.
Considering that - to my knowledge - FDA explicitly refrains from setting limits in their guidance, does anybody know the origin of these numbers? Have other Health Authorities than FDA published limits?
Thank you!
Hi MCre,
this previous posting might be of some help:
http://www.askaboutvalidation.com/forum/showthread.php?900-Recovery-Factor-in-cleaning-validation
Mark