生命科学 eQMS 14 项
Visual Inspection of Parenterals Checklist (USP <790>)
此检查清单为英文版。
Confirms that injectable products are 100% inspected for visible particulates and defects and that the inspection program is validated with qualified inspectors and defect libraries. Use to establish or audit visual inspection.
USP <790>USP <1790>EU GMP Annex 1
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Inspection Program Requirements
- Is every unit of injectable product subject to 100% inspection for visible particulates? *
- Are inspection conditions (light intensity, background, viewing time) defined and controlled? *
- Is the light intensity at the inspection point verified to meet 2000-3750 lux (or higher for difficult products)? *
- Record the measured light intensity at the inspection zone (lux).
Defect Library and Classification
- Is a defect classification scheme in place (critical, major, minor)? *
- Is a physical or image-based defect library maintained with representative defect standards? *
- Are defect standards periodically verified and controlled?
Inspector Qualification
- Are manual inspectors qualified using a test set with known accept/reject units? *
- Is inspector performance requalified at a defined frequency? *
- Are vision, including near-vision and color, requirements defined and periodically checked? *
- Are rest breaks and maximum inspection durations managed to control fatigue?
Automated Inspection and AQL
- Are automated or semi-automated inspection systems validated against manual inspection? *
- Is a statistically based acceptance quality limit (AQL) inspection performed on accepted lots? *
- Are rejects reconciled, quantified, and trended for defect types? *
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