Module 16 2022

Risk Control

B Reduce Hazard from fault conditions: (particulates): Improve the manufacturing process, include Visual Inspection on each vial Hazard (Particulates) – Hazardous situation (Injection of particulates) – Harm (Severe allergic reaction)

A

Reduce Hazardous situation (injection of particulates): Increase clarity of the vial, train the users

C

D Reduce all : Implement all the abovementioned Risk Control measures together (process improvement, IFU instructions, use of only non allergenic materials)

Reduce Harm (Severe allergic reaction): Reduce the number of allergenic materials used in the manufacturing of the product

These all depend on Intended Use and Patient Population!!

15

Business Use Only