Microbiological Best Laboratory Practices

Programme

Module 1: Validation According to the Pharmacopoeias

Validation Requirements
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
Media
Validation tests
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
Testing Methods
Efficacy testing against Isolates
Validation Approach
Guidelines

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

Interactive Sessions
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.
Marcel Goverde

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

Endotoxin Testing
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.
Colin Booth

Environmental Monitoring
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.
Arjan Langen

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?