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Analytical Procedure Lifecycle Management

20 November 2018

A holistic Approach to Design, Development, Qualification and Control of Analytical Procedures and launch of the new ECA Guideline.

Background & Objectives

The assurance of ‘fitness for purpose’ of analytical procedures is a critical part of any process for ensuring drug quality. Since 2011, 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. Thus the panel has published articles and a proposal for a new General Chapter in 2017. This is under revision based upon comments received, and it is expected that a new version will be issued in 2018.

In addition, the long anticipated revision of the ICH Q2(R1) “Guideline on Validation of Analytical Procedures: Text and Methodology” has been sanctioned and the work plan is scheduled to commence in Q3 2018. It is also proposed to develop a new quality guideline on Analytical Procedure Development. It is intended that the new guidelines will be consistent with ICH Q8(R2), Q9, Q10, Q11 and Q12.

In the light of these developments ECA’s Analytical QC Group has developed a new Guideline on Analytical Procedure Lifecycle Management. It is consistent with the ICH and USP principles and provides detailed assistance in their practical implementation. This Guideline will be formally launched at this pre-conference workshop. And as a participant you will exclusively receive a copy. The ECA AQCG has also conducted a survey to find out more about the current status and issues regarding implementation of APLM in industry. The results and conclusions will be shared at this workshop.

Every participant will receive the current version of the ECA Laboratory Management Guidance Analytical Procedure Lifecycle Management

This comprehensive (around 80 page) Guidance Document Analytical Procedure Lifecycle Management covers the following topics

  • Key References
  • Quality involvement/Responsibilities
  • Rationale for this Guideline
  • Principles of Analytical Procedure Lifecycle Management (APLM)
  • Prerequisites for the APLM
  • Guidance recommendations for the 3 stages analytical procedure of the APLM
  • Stage 1: Procedure Design and Development
  • Procedure development and gaining understanding
  • Stage 2: Procedure Performance Qualification
  • Stage 3: Procedure Performance Verification
  • Technical Glossary

Target Audience

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.

Congress Keynote

Congress Keynote 20.11.2018: Alternative Microbiological Methods: AstraZeneca's, GSK's, Johnson&Johnson's, MSD's and Roche's Global Implementation Roadmap

Alternative Microbiological Methods: AstraZeneca's, GSK's, Johnson&Johnson's, MSD's and Roche's Global Implementation Roadmap
Miriam Guest, Astra Zeneca / Philip Breugelmann, JnJ / Dr Sven M. Deutschmann, Roche

  • Introduction & Overview
  • Alternative Microbial Enumeration Method(s)
  • Alternative Sterility Test(s)
  • Alternative ID-Test(s)

Programme

Overview of the new APLM Guideline and the Workshop
Dr Christopher Burgess, Chairman of the ECA AQCG Board

  • Principles of Analytical Procedure Lifecycle Management (APLM)
  • Importance of adopting an APLM approach in the context of data integrity governance
  • Limitations of the current ICH Q2(R1) & USP General Chapters
  • ECA Guidelines; intent and application for laboratory data integrity
  • Content of new APLM guideline
  • Workshop intent and processes

Stage 1: Procedure Design and Development
Margarita Sabater, ECA AQCG Board

  • Defining the Analytical Target Profile (ATP)
  • Defining the Target Measurement Uncertainty (TMU)
  • Quality by Design; Application to Analytical Procedures
  • Risk Management for Analytical Procedures
  • Defining an Analytical Control Strategy

Stage 2: Procedure Performance Qualification (PPQ)
Dr Gerd Jilge, ECA AQCG Board

  • Alignments, differences and advantages to traditional ICH validation
  • General and procedure-specific performance attributes
  • Experimental confirmation in stage 2 or reference to stage 1?
  • Precision of the reportable value and replication strategy

Stage 3: Procedure Performance Verification
Silviya Dimitrova, ECA AQCG Board

  • Analytical Procedures as processes
  • Process stability and capability
  • Requirements for routine process monitoring of analytical procedures
  • Quality Metrics
  • What to trend and what not to trend
  • Trending as part of the analytical control strategy and confirmation of the ATP
  • Are we trying to control means or individuals?
  • Overview of trending tools for discrete and variable data

APLM Questionnaire
Dr Christopher Burgess, Chairman of the ECA AQCG Board

  • Structure and intent
  • Analysis of the Responses
  • Conclusions

Workshop Critique of a SWOT Analysis of the APLM
All members of the ECA AQCG Board

  • What is a SWOT Analysis?
  • Review of a SWOT Analysis for an APLM
  • Interactive discussion
  • Conclusions and the way forward

ICH Concept Paper for Revision of Q2(R2) & Q14
Dr Christopher Burgess, Chairman of the ECA AQCG Board

Interactive discussion of the ICH implications and Questions
All members of the ECA AQCG Board

Speakers

Dr Christopher Burgess, Burgess Analytical Consultancy Limited, UK
Chairman of the ECA Analytical Quality Control Working Group. Qualified Person” in the EU. Member of the USP Expert Panel on Validation and Verification entrusted to revise General Chapters.

Silviya Dimitrova, TEVA Bulgaria
Member of the ECA QC Group Board and QP. Overall responsibility for quality oversight of European TEVA suppliers as well as QC and QP Release.

Dr Gerd Jilge, Boehringer Ingelheim Pharma, Germany
Quality Control. Member of the EDQM expert group 11 and Board Member of the ECA QC Group.

Margarita Sabater, Dako Denmark, an Agilent Technologies Company
Manager Compliance Support at Dako. Board Member of the ECA QC Group.