Problem: APS is a hot topic & area of focus of USFDA & EU regulatory inspections. It costs a lot when not in compliance (warning letters, patient safety) and also when overdesigned without applying risk based approach. Target: After Annex 1 updates with more details, introduction of CCS concept and more focus on quality risk management, To design APS that is satisfying all regulatory requirements in a cost effective risk based way. Proposal: 1- Rapid review of APS & its importance. 2- Where in Annex 1 APS was mentioned? 3- Relationship between APS, CCS & QRM. AS0 is a part of CCS (validation & monitoring). QRM is essential for developing CCS & APS design; however priority should be given to design controls, followed by procedural controls and finally to monitoring systems. 4- How to use QRM in APS to focus resources on real risks. 5- Practical examples of cost effective risk approach to APS. 5 1. How to simulate different dosage forms on same line with minimum no. of runs. 5.2 How to use risk assessment to define a risk based frequency for intervention simulation. 5.3. How to use QRM to simulate all container sizes with minimum no. of runs.
Senior Quality Manager Biologics F&F and New Projects,
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