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생명과학 eQMS 14개 항목

Visual Inspection of Parenterals Checklist (USP <790>)

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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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