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Combination product essential performance requirements (EPR’s) interpretation and control strategy development – A MediPhorum appraisal

14 April 2024
MediPhorum Drug Delivery
Combination product essential performance requirements (EPR’s) interpretation and control strategy development – A MediPhorum appraisal
2.46 MB
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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​.

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Implementation of Article 117 of European Union Medical Devices Regulation (EU MDR) General Safety and Performance Requirements: a position paper