Wednesday, March 19, 2014

FDA Reduces GMP Inspections by 40 Percent, Focuses on Imports - PharmaManufacturing

FDA Reduces GMP Inspections by 40 Percent, Focuses on Imports - PharmaManufacturing:

"The FDA plans to conduct 591 domestic good manufacturing practice (GMP) inspections in fiscal 2014 and 2015, down from the 967 performed last year. The agency in turn hopes to perform 30 percent more foreign GMP inspections, conducting 843 inspections each year, up from last year’s 604. Companies will be chosen for inspection based on the agency’s risk-based inspection model that grants leeway to high-quality companies. The FDA takes into account risk factors including Class I recalls and adverse events, as well as compliance history, in applying the risk-based inspections model to its decision making."

'via Blog this'

You might also be interested in:
GMP Trainer Certification Workshop - May 5-9, 2014 Public Seminar - Fort Lauderdale, FL
Surviving An FDA Inspection - a GMP Training Course

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around
SkillsPlus Intl Inc. - Sign-up for our announcements via Constant Contact


No comments:

Post a Comment