US FDA launches overarching Office of Pharmaceutical Quality - iPT:
"Within the OPQ, the agency will create an Office of Surveillance, which will be tasked with creating new quality metrics, and will let OPQ inspectors know if they need to inspect manufacturing facilities during an NDA (new drug application) review.
After a new industry range of metrics is published, she added that FDA will take “the first two years to make sure we’re measuring apples and apples” and allow facilities to see where they stack up against competitors.
The agency will undergo the “same type of work but new inspection protocols will be” standardized and help industry understand how pre-approval and surveillance inspections can be done, Woodcock said."
'via Blog this'
Return to SkillsPlus International Info Blog - Home
SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around
New! cGMP Mini-Series - Multimedia clips to use in your GMP training
The cGMP Trainer Professionals Resources Blog
Sign-up for SkillsPlus Intl Inc Announcements via Constant Contact