Why Inspect? parenteral injecton visual inspection shandong hawkeye US FDA 483 Themes
Patient Risk – Physiological Implications • Particles – Chemical and Microbiological Implications • Particles, Container Integrity • Compendial Requirements – Pharmacopeias • Regulatory Requirements • Process Knowledge and Continuous Process Improvement • Must establish a maximum allowable reject rate. • Must control reinspection of product, including when appropriate, inspection conditions and number of reinspections permitted. • Inspectors must be trained, and training documented. • Inspectors must be periodically requalified. • Training and qualification conditions must align with routine 100% inspection conditions. • Address inspection fatigue during qualification. • Must use statistically sound sampling plan(s) for AQL inspection. -0086-13589838190
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