Overview on the analytical procedure lifecycle – USP (1220), ICH Q14, ICH Q2(R2)
Joachim Ermer Overview:
Lifecycle and Quality-by-Design approaches have been in the focus of the International Council of Harmonisation (ICH) since the mid 2000 years (ICH Q8-12, EU and FDA Process validation guidelines) focusing on the manufacturing process. Now, such an approach is increasingly adopted with respect analytical procedures, as emphasized in the USP General Information Chapter <1220> (May 2022), and in the just published new ICH guidelines Q14 “Analytical procedure development” as well as the revision of the ICH guideline Q2(R2) “Analytical procedure validation”.
The core is a comprehensive and enhanced understanding of the analytical procedure performance across the whole lifecycle, i.e. the assurance that a method is suitable for its intended purpose whenever applied.
Why you should Attend:
A holistic understanding of the analytical procedure lifecycle will support realistic assessment of analytical performance, as well as the identification of the need for continuous improvements, resulting in more robust and reliable analytical procedures. Stage 3 (continuous monitoring) provides opportunities to gain comprehensive understanding and improvements for legacy methods not developed by QbD principles.
Areas Covered in the Session:
- Historical development, alignment with manufacturing process
- EFPIA/PhRMA Paper and the USP Expert Panel publications
- USP General Information Chapter <1220>, 3 Stages of the lifecycle
- Procedure design and understanding
- Procedure Performance Qualification
- Ongoing Procedure Performance Verification
- ICH Q14 "Analytical procedure development"
- Analytical Target Profile (ATP), ICH Q12 and regulatory flexibility
- ICH guideline Q2(R2) "Analytical procedure validation"
Who Will Benefit:
- Analysts, lab supervisors and Managers in Analytical Development and Quality Control responsible for method development, optimization, validation, and application.
- Quality Assurance and regulatory affairs representatives responsible to approve or evaluate analytical procedures
Speaker Profile
Dr. Joachim Ermer is a biochemist with 30 years of experience in pharmaceutical analytics, including development products at Hoechst AG, global responsibilities as Director of Analytical Processes and Technology at Aventis, and head of Quality Control and head of QC Lifecycle Management Frankfurt Chemistry at Sanofi. From 2010 till 2020, he was also responsible for the central reference standard group and Global Reference Standard Coordinator of Sanofi. Since December 2020, he serves as consultant for topics of pharmaceutical analytics and Quality Control. Joachim Ermer is member of the USP Expert Committee “Measurement and Data Quality“, of the Ph.Eur. Working Group “Chromatographic Separation Techniques”, and Advisory Board member of the ECA Analytical Quality Control Group.
He authored more than 60 publications on analytical topics and contributed to the USP General Information Chapter <1220> as well as other Stimuli Articles. He is editor and author of the book “Method Validation in Pharmaceutical Analysis. A Guide to Best Practice” (Wiley-VCH, 2005, 2015, 2024).