Integrating QSIT into Quality Plans

• Date: November 04, 2008

Quality System Inspection Technique – FDA’s new approach to enforce regulation and compliance aims to improve speed, efficiency and consistency of both routine and pre-approval inspections. CDER has defined and grouped QSIT into six major systems as:

• Quality
• Facilities and equipment
• Materials
• Production
• Packaging and labeling
• Laboratory control

What do these broad headlines mean and how to implement QSIT?