ECA-Pre-Conference Workshop Validation of Alternative/Rapid Microbiological Methods
5 May 2020, Barcelona, Spain
Course No. 17842
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 Group
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
Alternative methods in the European Pharmacopoeia Dr Emmanuell Charton, EDQM
Relevant texts
Current expectations
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
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
Validation Approach for an Alternative Method in Pharmaceutical QC Dr Marja Claassen & Dr Pieta IJzerman-Boon, MSD
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
This course is part of the GMP Certification Programme "ECA Certified Microbiological Laboratory Manager" Learn more
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