Integrating QSIT into Quality Plans
Abstract: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?
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