Consulting and Training
in pharmaceutical analysis and
Quality Control

Welcome to my website!

I would be pleased to support you, to provide consulting or training with respect to topics of pharmaceutical analysis and Quality Control. My name is Dr. Joachim Ermer and I rely on a long-year experience in pharmaceutical industry.

Following study of biochemistry and PhD thesis in enzyme kinetics at the Martin-Luther-University Halle-Wittenberg in 1988, and a post-doc scholarship in Cambridge, UK, I was employed in various positions in industrial Quality Control since 1991. My special interest has always been analytical validation and method performance as well as related topics such as out-of specification results (OOS), transfer, practical statistics, Quality-by-Design, or lifecycle management. My long-standing participation and discussions in national and international working groups provided me with possibilities to participate as well as to take influence in these developments.

My responsibilities in pharmaceutical analysis included the position of head of laboratory within the analytical drug development at Hoechst AG, Frankfurt, Germany, and from 2001 to 2005 a global function as Director of Analytical Processes and Technology. This comprised consultation, harmonisation, trouble-shooting and training of all industrial sites of Aventis with respect to Quality Control topics, including creation and development of company guidelines.

From 2005 to 2010, I served as head of Quality Control Frankfurt Chemistry, Sanofi, Germany. Between 2010 and 2018 my responsibilities as head of QC Services included a reference standard group with the mission to provide Sanofi-wide management and distribution of analytical reference standards. From 2018 to 2020, as head of QC Lifecycle Management Frankfurt Chemistry, I have evaluated compendial and regulatory changes, supported and coordinated analytical transfers, validation and implementation projects. In order to ensure the suitability and compliance of analytical procedures during the lifecycle, I have developed a quality system for continuous performance verification of all API-methods (monitoring) and accompanied its implementation.

News

Eventually, December 20, 2023, revision 2 of the ICH validation guideline and the new Q14 guideline “Analytical Procedure Development” were published at the ICH website (https://www.ich.org/page/quality-guidelines). Although the validation guideline cannot be considered as a “masterstroke”, some of the deficiencies have been tackled, for example response (calibration model) instead of “linearity”, as well as some new requirements, e.g. consideration of uncertainty in the evaluation of accuracy and precision (confidence intervals). The ICH decision to keep the two separate guidelines can only be regarded as “congenital defect”, as it contradicts a holistic understanding of the analytical lifecycle.