Combination product essential performance requirements (EPR's) interpretation and control strategy development - A MediPhorum appraisal
The MediPhorum EPRs for Device Specification Setting workstream has been discussing the current interpretation of Essential Performance Requirements (EPRs). What is evident to the team is that each company has varying sources of reference in how to interpret/determine EPRs leading to non-homogenous approach to EPR identification. Each company looks to industry guidance to determine EPRs with varying sources of reference leading to non-homogenous approach to EPR identification.
The team findings were that not all EPRs are assessed at finished product batch release testing, but clear rationales are provided at upstream controls during material incoming control, semi-finished product testing, or process validation for finished product assembly.
This presentation given by two MediPhorum subject matter experts at the Pre-filled Syringes east coast conference in April outlines the team's findings. Following the presentation, the two MediPhorum workstream members were involved in the FDA Panel discussion: Evaluating the pre-filled syringes and injectables drug devices regulatory landscape
|MediPhorum EPR presentation SAE Boston April 2023.pdf|
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