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. 


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