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EU24CEMAR1/SES213 - ICHQ9(R1) Compliant Risk assessment for CCS

‐ Mar 13, 2024 3:00pm

A key requirement of the revised Annex 1 is following QRM principles and preparation of a Contamination Control Strategy: CCS. ICHQ9(R1) covering QRM has been revised alongside Annex 1 to improve risk assessments and reduce subjectivity. This presentations presents a new PHSS FMECA: Failure Modes Effects & Criticality Analysis where criticality has a focus on sterile product contamination in support to CCS preparation. This two phase FMECA follows the intent of Annex 1: 'Monitoring and Testing alone does not give assurance of sterility' hence a focus on design, product protection from contamination in stage 1 Classification of Risks before assessing detectability in stage 2 to define a risk ranking. The EXCEL model will be explained with a worked example: Fill & Finish project used to make clear how the FMECA process is executed. James Drinkwater has facilitated this FMECA model on a number of project so can share experience and learning.