Joachim Ermer is head of Analytical Lifecycle Management Chemistry Frankfurt at Sanofi.
Ongoing Analytical Procedure Performance Verification—Stage 3 of USP<1220>
Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.
Analytical Procedure Lifecycle Management: Current Status and Opportunities
Drawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
Three Examples of Hypothetical ATPs
Three hypothetical analytical target profiles (ATPs) are provided, reflecting the current thinking of the the European Federation of Pharmaceutical Industries and Associations Analytical Lifecycle Management Team.