In 2017, the board of the ECA's Analytical Quality Control Group (AQCG) decided to support the lifecycle approach for analytical procedures by drafting a new Guideline on 'Analytical Procedure Lifecyle Management' (APLM).
Topics to be presented and discussed in this comprehensive guideline are:
Rationale for this Guideline: - Limitations of the current ICH Q2(R1) - Limitations of USP General Chapters <1224>, <1225> and <1226> - Importance of adopting an APLM approach in the context of Data Governance
Principles of Analytical Procedure Lifecycle Management (APLM): - Defining the requirement; The Analytical Target Profile - Establishing Target Measurement Uncertainty - Specifications and Decision Rules
Prerequisites for the APLM
Training of analytical staff
Guidance recommendations for the 3 stages analytical procedure of the APLM
Stage 1: Procedure Design and Development - Application of AQbD Principles in Analytical Procedures Lifecycle - Application of Quality Risk Management principles over the Analytical Procedures Lifecycle - Process for Procedure Design and Development - Robustness - Establishing an Analytical Control Strategy and Documenting the Analytical Procedure
Stage2: Procedure Performance Qualification
Confirming Critical Analytical Performance Parameters - Selectivity (Specificity) - Analyte Response Function over an operational range (Calibration model) - Accuracy and Recovery over an operational Range - Precision - Critical Analytical Performance Parameters by Product Type - System Suitability Tests - Verification and Transfer requirements for qualified analytical procedures
Stage 3: Procedure Performance Verification - Analytical Procedures as processes - Process stability and capability; analytical procedure Quality Metrics - Requirements for routine monitoring of analytical procedures - Trend analysis using statistical process control tools - Deviation Management and Change Control
Conference presentations, case studies and workshop discussions will help participants learn more about the current thinking with regard to lifecycle management of analytical procedures and provide a forum for discussing how to move forward with the transition to and implementation of the lifecycle approach.