Inspection Preparation

/Inspection Preparation
Inspection Preparation2018-02-14T11:42:35+00:00

  • A New FDA Model

The New FDA GMP Inspection Model

August 13th, 2018|3 Comments

While the drug GMPs haven’t changed much, if at all, in recent years, the FDA is planning for significant changes in how drug GMP inspections are scheduled and conducted. Last year, the FDA made available a description of their new operating model that will ensure integration of review and inspection activities for human drugs. This post dives deep into this model – including new timelines for those of us in the drug industry.