Module 1: Basic Requirements for Microbiological Laboratories
Training and Qualification of Analysts
- A structured training programme for microbiologists what they need to know and why
Method Suitability Test - Requirements and Materials
Designing a MST strategy
- Worked examples of MST, creams, liquids, tablets
- Sterility test validation: why do so many laboratories get it wrong?
- MST for difficult formulations
- Validation and robustness are they the same thing?
- Transferring methods to other laboratories, what do you need?
- Microbial cultures, selection and maintenance
- Microbiological media: how to make it, store it and test it
Method Validation According 5.1.6.
- Background and revision of chapter Ph. Eur. 5.1.6
- Validation process
- Accuracy, Precision, Specificity, LOD, LOQ, Linearity, Range, Robustness
- Case study for the Milliflex Quantum System
Module 2: Compliant Microbiological Test Methods
Microbial Enumeration Test for Non-Sterile Products
- The harmonised approach USP/Ph.Eur. /JP
- Relevant parameters in the test procedure
- Choosing the most suitable test method
- Microbial quality of excipients, API and final dosage forms
- Defining alert levels based on historical data
- The approach of risk assessment testing
Bacterial Endotoxins/Test Validation
- Principles of the techniques
- Gel-clot techniques
- Photometric techniques
- Preparatory testing / validation tests
The Test of Sterility
- Method suitability tests
- Test procedures
- Membrane filtration method
- Direct transfer or direct inoculation method
Tests for Specified Microorganisms
- Testing Methods
- Challenges concerning the suitability testing
- How to choose the right growth media supplier
- What are objectionable micro-organisms
Rapid Microbiological Methods
- Overview on the current RMMs
- Limitations and benefits of the different RMM?
- Monitoring of non-sterile processes
- Aseptic manufacture:
- developing a programme
- interpreting data
- regulatory requirements
- Monitoring methods; air, surface, people
- A complete programme for a sterile product
Module 3: The Real World - A Workshop Day
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 analysing 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.
Risk Assessment and Trending
This workshop will give you an insight in trending of microbiological data and principles of microbiological risk assessments. It will cover the regulatory background like ICH Q9 and make you familiar with risk identification tools like FMEA (Failure Mode and Effects Analysis) or FTA (Fault Tree Analysis)
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.
Module 4: Further Challenges in Modern Microbiological Labs
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?
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?
Disinfection – Efficacy Testing and Validation
- Antimicrobial Agents and their Efficacy
- Testing Methods
- Efficacy testing against Isolates
- Validation approach
Lab Layout and Equipment Qualification
- Clean and dirty concepts
- Avoiding cross contamination
- Layout requirements for a PCR Lab
- Equipment Qualification – Points to consider for a microbiological Lab
- Capturing changes in your process
- When is a change not a change?
- Change control after the event!
- Your change control process, making it robust