Dr. Hans-Joachim Anders
Novartis Pharma Stein
Referent:innen
Arjan Langen
GE Healthcare
Dr. Stefanie Bayer
Labor LS
Zielsetzung
It is the aim of this course to familiarise responsible personnel from production, quality assurance and engineering with microbiological questions. The participants learn how to interpret microbiological data and which consequences these have for the production.
Hintergrund
The quality of drugs and the quality assurance during production are above all determined by their microbiological characteristics. The microbiological requirements on drugs are laid down in various regulations. When an authority inspects a company, it will focus its attention on these and on the requirements made on hygiene.
In their daily work, the responsible personnel in the production units has to understand microbiological results and evaluate their significance for further decisions. However, in practice many microbiological results are misinterpreted and thus often the wrong conclusions are drawn from them. When asked for the most frequent misinterpretations of microbiological results, pharmaceutical microbiologists gave the following answers.
In their daily work, the responsible personnel in the production units has to understand microbiological results and evaluate their significance for further decisions. However, in practice many microbiological results are misinterpreted and thus often the wrong conclusions are drawn from them. When asked for the most frequent misinterpretations of microbiological results, pharmaceutical microbiologists gave the following answers.
- The difference between bioburden and sterility testing (are they the same?)
- The use of disinfectants guarantees the sterility of the object, surface, culture treated.
- The distribution of microorganisms in a sample or on a surface is uniform.
- Motile microorganisms can swim hundreds of meters in an hour causing contamination problems in remote parts of the facility.
- How can different media formulations give different results?
- Microbial tests described in the Pharmacopoeias can always be validated, no matter what the matrix is, how aggressive it is, e.g. NaOH, how high the concentrations of antibiotics are etc.
- Identification results are absolute and unequivocal, especially when computer-generated.
- Underestimating the importance of cleaning prior to disinfection.
- Environmental monitoring results provide an accurate risk assessment during production.
- How can clean room surfaces not be heavily contaminated when the air counts are out of specification?
- How can endotoxins be present when the bioburden is nil?
- How can the titre of a virus reference standard change according to the detection cell line used?
- WFI is sterile.
- Filters are absolute.
- UV light disinfects and is capable of sterilising surfaces and water.
This listing appears to cover all aspects of microbiology from the interpretation of straightforward issues concerning environmental monitoring, bioburden results and identifications – through to the more complex issues surrounding virology results for the biologics/biotech people.
The misinterpretation of microbiological results often gives rise to the following misunderstandings:
The misinterpretation of microbiological results often gives rise to the following misunderstandings:
- Huge environmental monitoring programmes (more is better).
- Rejection of batches due to minor out-of-specification results.
- Delayed registration objectives and to attend appeal hearings.
- Numerous contamination incidents due to the application of inappropriate solutions to problems.
- Senseless promises made to regulatory authorities without scientific rationale based on the concept of Quality.
Zielgruppe
This course is designed for responsible personnel from production, quality assurance, regulatory affairs and engineering that has to make judgements, release products and take actions on the basis of the microbiological data supplied.
Presentations / Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
After the event, you will automatically receive your certificate of participation.
After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
The Characteristics of Microorganisms
- Fungi
- Bacteria
- Mycoplasma
- Viruses
- Cellular organisation, function
- Products, toxins, endotoxins, antibiotics, enzymes
Microbial Growth
- How it occurs
- What is required for growth?
- Growth kinetics – laboratory culture versus nature
- Effect of stress factors on growth
Microbial Identification Techniques
- What is the significance of a name?
- Distribution of microorganisms in nature, raw materials and water
- Distribution of microorganisms in pharmaceutical facilities
Detection Methods and their Limitations
- What can be detected by:
- The sterility test
- The bioburden test in its various forms:
- Membrane filtration, pour plate, spread plate, MPN
- The test for specified organisms
- The endotoxin test - Limits of detection and factors effecting limits of detection
Microbiological Methods: Suitability Test vs. Method Validation
The difference between a Method Suitability Test (MST) and a Method Validation will be explained using selected examples:
- The practical realization of a MST of a Microbial Enumeration Test (Ph.Eu. 2.6.12 / USP <61>) and a Sterility Test (Ph.Eu. 2.6.1/ USP <71>) is presented
- The Method Validation of a Rapid Sterility Test according to Ph.Eu. 5.1.6 / TR33 / USP <1223> is shown
Cleaning, Sanitation, Disinfection
- Why cleaning before disinfection?
- The difference between cleaning and disinfection
- Disinfectants and their efficacy
- Methods of disinfection
- Disinfection validation
Environmental Monitoring
- Sampling techniques
- Air sampling
- Surfaces
- Settle plates
- Technical limitations and interpretation of results
- Is there a relationship between high results and contaminated product?
Case Studies on Monitoring and Hygienic Deviations
Pharmaceutical Water - Microbiological Control and Deviation Management
- Regulatory requirements
- Warning and action Limits
- Measures to be taken when warning and action Limits are exceeded
- Repeated non-conforming results
- Examples of warning and action limit exceedance
- Source of microbial contamination, biofilms
Sterilisation Methods
- Principles and kinetics of sterilisation
- Selection of sterilisation method
- Types of sterilisation methods
- Validation of the sterilisation process
How to Handle Microbiological OOS Results
- Typical Out-Of-Specification results
- Sterility testing | Bioburden | Endotoxin testing
- Cleanroom monitoring - Investigation of causal Connection
- Laboratory failure investigations
- Sampling/process/production failure Investigation
- Type of microorganisms
- Deviations/incidents/assessment
- Deviation/investigation report - Retesting/Reanalysis/Resampling
- Definitions
- Calculation of mean values
- Rejection/Release
Trouble Shooting - Examples and Case Studies Sessions
The aim of these special sessions is to provide participants with practical experience of the basics of microbiological deviations and trouble shootings and the difficulties associated with evaluation. On the basis of real cases, sources of contamination, possibilities of root cause analysis and the determination of corrective and preventive measures are shown.
The aim of these special sessions is to provide participants with practical experience of the basics of microbiological deviations and trouble shootings and the difficulties associated with evaluation. On the basis of real cases, sources of contamination, possibilities of root cause analysis and the determination of corrective and preventive measures are shown.
| ECA-Member*: | € 1690,- |
| Non ECA Member*: | € 1890,- |
| EU/GMP Inspectorates*: | € 945,- |
| APIC Member Discount*: | € 1790,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Microbiological Laboratory Manager"
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