European Microbiology Conference 2020

Workshop “Validation of Alternative/Rapid Methods”

on 5 May 2020

Objectives

In this year’s workshop, different approaches for the validation of alternative microbiological methods will be presented on the basis of case studies by microbiologists and statisticians. In particular, the statistical approach will be considered and subsequently the advantages and disadvantages will be discussed. What were the experiences of the scientists, what solutions were pursued and how was the validation carried out?

Background

In a lecture on the European Pharmacopoeia Chapter 5.1.6, the EDQM defined Alternative Methods for Control of Microbiological Quality:
“The aim is to facilitate the implementation and use of alternative microbiological methods (AMM) where this can lead to cost-effective microbiological control and improved assurance for the quality of pharmaceutical products.

Even if the validation of alternative microbiological methods does not always prove to be easy, especially when it comes to demonstrating comparability with existing compendial methods, implementation in QC laboratories is making progress. It has been found that the collection, analysis and evaluation of the data obtained is of great importance for the validation of alternative and rapid methods. Especially if the
results of the alternative methods cannot be presented in the classical cfu, the authority expects “use of statistics to demonstrate equivalency between an alternative and a growth-based compendial method.”

However, there may be different statistical approaches that can be used in the validation process, depending on the method or which microbiological test is affected.

Target Audience

  • Microbiologists from pharmaceutical and biopharmaceutical Industry
  • Manufacturer of medical devices
  • Responsible QC/QA staff
  • Experts from contract laboratories
  • Manufacturer and suppliers of BI
  • Responsible Authorities

Programme

Dr Emmanuell Charton

Alternative methods in the European Pharmacopoeia

Dr Emmanuell Charton, EDQM

  • Relevant texts
  • Current expectations
 

Dr Viviane Grunert da Fonseca

Non-inferiority testing for RMM validation: Two use cases

Dr Viviane Grunert da Fonseca, Roche Diagnostics

  • Qualitative sterility test: Validation with respect to equivalence
  • Quantitative automated colony counter: Validation with respect to accuracy & precision

 

Dr Michael Miller

Validating a Rapid Sterility Test: Practical Strategies to Ensure Regulatory Compliance

Dr Michael Miller, Microbiology Consultants LLC

  • Review recent regulatory policies and compendial guidance for rapid sterility testing
  • Understand the required validation parameters including limit of detection, specificity, method suitability and equivalence
  • Consider sampling strategies when compendial requirements cannot be met
  • Discuss the impact of short-life products on detection time
  • Debate the need for using stressed microorganisms
  • Provide examples of real-life rapid sterility validation data

 

Dr Marja ClaassenDr Pieta IJzerman-Boon

Validation Approach for an Alternative Method in Pharmaceutical QC

Dr Marja Claassen & Dr Pieta IJzerman-Boon, MSD

 

Maria Eugenia Giribets Parra

From visual counting to automation of water monitoring with the Growth DirectTM

Maria Eugenia Giribets Parra, Boehringer Ingelheim

  • Build your business case to show the impact of automation in your lab
  • Define your validation strategy: dos and don’ts
  • The Growth DirectTM in routine: benefits and opportunities