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Colin Booth, Oxoid, UK
Dr Sven M. Deutschmann, Roche Diagnostics, Germany
Dr Marcel Goverde, MGP Consulting, Switzerland
Dr Holger Kavermann, Roche Diagnostics, Germany
Arjan Langen, MSD, The Netherlands
Most tests applied in microbiological QC are described in detail in the different Pharmacopoeias (e.g. EP, USP, JP). These methods are regarded as being validated –
but not for your products!
In the end, it is up to you to prove that the official
methods function in your environment. The validation of microbiological test methods for your needs consumes a lot of time, money and manpower. Things can get more complicated if your products interfere with the execution of the test.
The real challenge is to fulfil both, regulatory requirements and at the same time financial targets set by
During this 3-day workshop you develop strategies for a sustainable approach to the validation of microbiological test procedures. This course will give you clear guidance on how to cope with these tasks besides your routine laboratory work.
The key tool of this seminar will be team work. During interactive sessions you will create procedures for the most common microbial test methods. Our experienced ECA course leaders will moderate the discussions to lead you to practice-oriented solutions.
After completion of the course you will be able to cope with the validation of microbiological test procedures in a compliant and at the same time efficient manner.
To guarantee optimal conditions for the exchange of opinions and experiences, the number of participants
This course will provide practical guidance on implementing the harmonized test methods!
This GMP workshop is designed for
managers and supervisors of pharmaceutical
Furthermore, the course will be of interest to personnel from
regulatory affairs and
involved in the microbiological aspects of the
production and testing of medicinal products.
Module 1: Validation According to the Pharmacopoeias
Designing a validation strategy
Worked examples of validation, creams, liquids, tablets
Sterility test validation, why do so many laboratories get it wrong?
Validation of difficult formulations
Validation and robustness - are they the same thing?
Transferring methods to other laboratories, what validation do you need?
Materials Needed for the Validation
Microbial cultures, selection and maintenance
Microbiological media: how to make it, store it and test it
Routine validation of your QC laboratory instruments.
Managing your stock, laboratory inventory.
The Test of Sterility: Critical Parameters for a Validation of the Test Procedures
- Membrane filtration method
- Direct transfer or direct inoculation method
Bacterial Endotoxins/Test Validation
Principles of the techniques
- Gel-clot techniques
- Photometric techniques
Preparatory testing / validation tests
Tests for Specified Microorganisms
Implementation of the harmonised methods
Challenges concerning the suitability testing
How to choose the right growth media supplier
What are objectionable micro-organisms
Disinfection – Efficacy testing and Validation
Antimicrobial Agents and their Efficacy
Efficacy testing against Isolates
Microbial Limit Test for Non-sterile Products
The harmonised approach USP/Ph.Eur. /JP
Relevant parameters in the test procedure
Choosing the most suitable test method
Suitability test: what should we report?
Microbial quality of excipients, API and final dosage forms
The approach of risk assessment testing
Module 2: The Real World
You will participate in 3 workshops!
These interactive sessions are an excellent forum for fruitful discussions. You will develop testing and validation strategies that can be transferred directly to your lab. The ECA course leaders take care that you stay
focused on the pre-defined exercises.
The Harmonized Methods for Testing of Non-sterile Products
The goal of this workshop is encourage the participants to think globally when analyzing microbiology problems. Microbiology problems are subtle and often multifactorial in their origin. The workshop will show you tips and tricks in testing methods and a possibility to discuss the issues of the implementation of the harmonized methods like growth promotion testing, creating an implementation concept and necessary investments.
Rapid Microbiological Methods
This workshop offers you a unique possibility to evaluate the new developments in RMM systems to extend the experiences in validation and implementation of these systems in pharmaceutical industry. Furthermore you will learn more about the expectations of European and US authorities.
Sven M. Deutschmann, Holger Kavermann
Routine endotoxin testing should be straightforward, sometime there are problems in the assay, we will explore examples of faults that have occurred in routine testing, and how to fix them. However the major part of this workshop will be to work through problems of validating the assay both in Gel Clot and in the Kinetic Chromogenic assays. We will review data from real
examples and discuss the options for resolution of the issues.
The workshop gives you an understanding of how to set-up an environmental monitoring programme, and how to handle excursions. The discussions will focus on initial qualification vs. routine monitoring, how many samples are reasonable, reporting structure of environmental monitoring data, corrective actions and the impact of environmental data on product release.
Rapid Microbiological Methods
Overview on the current RMMs
Limitations and benefits of the different RMM?
Dealing with OOS-Results
How do we define alert and action limits?
How should we react on Out-Of-Specification results?
How can we perform a proper Failure Investigation?
Change Control and Training of New Personnel
Capturing changes in your process
When is a change not a change?
Change control after the event
Your change control process, making it robust
A structured training programme for microbiologists, what they need to know and why
Identification Techniques – Phenotypic / Genotypic
Phenotypic and genotypic identification techniques-advantages and limitations
A change from phenotypic to genotypic identification and the surprises
New Methods - what’s in sight?