"Analytical Procedure Lifecycle Management" Guidance for all participants of the APLM Conference

Recommendation

7/8 May 2024

EU GMP-/FDA-compliant Sampling - Live Online Training

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:

• Regulatory References
• Quality involvement/Responsibilities
• 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
• Technical Glossary

The APLM Conference on 23-24 November 2017 in Vienna, Austria, will launch this draft guideline and actively discuss and review it as well as provide input for the finalized version 1.

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.