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Introduction

Validation of analytical procedures is an important topic in pharmaceutical Quality Control: “(e) The accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented.” [CFR§211.165] Therefore, this topic was among the first tackled by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), with publication of the Q2 guideline in 1994. However, during the following years, we faced tremendous developments towards adoption of Quality-by-Design principles and holistic lifecycle management, such as the ICH Guidelines Q8-12, the FDA and EU process validation guidelines, or the USP General Information Chapter <1220> “The Analytical Procedure Lifecycle”. 

In face of these developments, some gaps, and uncertainties of the Q2 guideline and became more and more obvious, such as the major focus of Q2 on chromatographic methods, the lack of clarity what suitability means, or the confusion between the response function of the analyte in solution (calibration model) and linearity of the analyte in the sample (accuracy). Consequently, ICH decided in 2018 to revise the validation guideline, and to create a new guideline Q14 “Analytical Procedure Development”. After some delays, the draft guidelines have been published for public consultation, end of March 2022. Eventually, now the final guidelines have been released by ICH and adopted by the regulatory bodies of the ICH regions (which have been enlarged to include now 15 regulatory members, among them Brazil, Mexico, China, Korea, or Turkey.

Who Should Attend

Key Takeaways

  • Validation protocol and acceptance criteria (Lack of the) Analytical Target Profile
  • Validation of platform analytical procedures
  • Multivariate analytical procedures
  • Use of data from development
  • Validation during the lifecycle, links toICHQ14
  • Specificity / selectivity
    • Technology inherent justification
  • From Linearity to Response (calibration model)
    • Linear, non-linear, multivariate
  • Validation of lower range limits (detection and quantitation limit, reporting threshold)
  • Accuracy
    • Comparison, spiking studies (recovery)
    • Consideration of parameter uncertainty: Use of confidence intervals
  • Precision
    • Repeatability, intermediate precision
    • Missed precision levels: system/measurement precision, precision of the reportable result
    • Consideration of parameter run certainty: Use of confidence intervals
  • Combined evaluation of precision and accuracy
    • Use of prediction, tolerance, confidence intervals
  • Quantitative separation techniques (assay and relative area quantitation)
  • Elemental impurities by ICP-OES/MS
  • Dissolution for immediate release (quantitation with HPLC)
  • Biological assays
  • Particle size measurement

Meet The Trainer

Following study of biochemistry and PhD thesis in enzyme kinetics, Dr. Ermer started his career in pharmaceutical analytics and industrial Quality Control in 1991. He held various positions, including 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 included consultation, harmonization, troubleshooting and training of all industrial sites of Aventis with respect to Quality Control topics. From 2005 to 2010, he served as head of Quality Control Frankfurt Chemistry, Sanofi, Germany. Between 2010 and 2018, Dr. Ermer was head of QC Services which included a reference standard group with the mission to provide company-wide management and distribution of analytical reference standards. From 2018 to 2020, he held the responsibility as head  of QC Lifecycle Management Frankfurt Chemistry, and evaluated compendial and regulatory changes, supported and coordinated analytical transfers, validation and implementation projects, in particular the establishment of a quality system and routine monitoring program for continuous performance verification of all API-methods.

Dr. Ermer is member of the USP Expert Committee “Measurement and Data Quality“, and of the .Eur. Working Group “Chromatographic Separation Techniques”. He authored more than 60 publications on analytical topics and is editor and author of the two editions of the book “Method Validation in Pharmaceutical Analysis. A Guide to Best Practice” (Wiley-VCH, 2005 and 2015). The third edition is in preparation and scheduled for publication mid-2024.

Dr. Joachim Ermer

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