Analytical Procedure Lifecycle Management
Featuring Speakers from ECA Analytical QC Group and
USP Validation and Verification Expert Panel
November 23rd - 24th 2017, Vienna, Austria
- Scope and Application of the new Analytical Procedure Lifecycle Management (APLM) Guideline
- Quality by Design - Application to Analytical Procedures
- Development of an ATP
- The importance of Target Measurement Uncertainty in an ATP
- Defining an Analytical Control Strategy
- Aims and Objectives of the ICH Q2A Revision Process
- Designing Procedure Performance Qualification (PPQ) - Stage 2
- On Going Performance Verification; Stage 3
- Procedure Verification Strategy to Confirm a State of Control
Objectives & Background
The assurance of ‘fitness for purpose’ of analytical procedures is a critical part of any process for ensuring drug quality. Since 2014, USP’s Validation and Verification Expert Panel has been considering how the modern concept of lifecycle model process validation can be applied to analytical procedures and has published articles and a proposal for a new General Chapter <1220> aligned with the principles of US FDA and EU Annex 15 guidance on process validation.
In November 2016, ECA held a joint workshop with USP in Prague to discuss developments. In addition, ICH have instigated a revision workplan for Q2(R1) on Analytical Method Validation scheduled for completion by 2019/2020. Also the new ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Step 1 Core guideline, June 2017, provides further support for the analytical procedure lifecycle and preparing the way for performance based procedures.
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).
This workshop conference will launch this draft guideline and actively discuss and review it as well as provide inputs for the finalized version 1. In addition, there will be an opportunity to discuss and generate input for the ICH Q2(R1) revision process. The speakers will be from both the ECA board and members of the USP’s Validation and Verification of Analytical Procedures Expert Panel.
Conference presentations, case studies and workshop discussions will help participants learn more about the current thinking on 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.
This meeting features 4 specifically designed interactive workshops on:
- Analytical Target Profiles (ATPs)
- Using Analytical Quality by Design methodology (AQbD) to deliver an ATP
- Designing a Procedure Performance Qualification (PPQ) protocol to confirm the ATP
- Designing a Procedure Verification strategy to confirm a state of control
The ECA Academy wish to actively involve analytical chemists, QC analysts, quality assurance associates & managers, R&D scientists, statisticians & managers as well as manufacturing scientists and managers, regulatory affairs specialists and contract laboratories in this critical area for analytical science.