Werner Hofstetter
Octapharma
Referent:innen
Robert G. Schwarz
GXP-TrainCon
Dr Inga-Marie Schlägl
GP Grenzach Produktions GmbH
Carsten Moschner
CMC3
Arjan Langen
GE Healthcare
Wolf-Dieter Wanner
Consultant
Walid El Azab
QP Pro Services
Axel Schroeder
Concept Heidelberg
Zielsetzung
In most cases, the implementation and execution of appropriate hygiene programmes and measures is an essential part of the manufacture of pharmaceutical products. A number of regulations deal with the subject of microbiological operational control, but often the GMP requirements are rather general. But how can they be implemented in pharmaceutical companies in a practical way? What is the state of the art? How should cleaning agents and disinfectants be used? What does a contamination control strategy look like?
The overriding aim of such a system is to prevent microbiological and particulate contamination of the pharmaceutical product. But even if such a system is established, it is of the utmost importance that these programmes and measures are understood and followed by all employees who carry out quality-relevant work. This is why the regulations require intensive training in hygiene issues.
And in the new Annex 1 of the EU GMP guidelines, the overarching integration of the individual measures with the contamination control strategy is now also clearly required.
Against the background of these requirements, this ECA training course is designed to cover all important aspects of microbiological and, to a lesser extent, particulate contamination control. It ranges from the sources of contamination to the validation of cleaning and disinfection processes and the training of operating personnel. Emphasis is placed on the problems frequently encountered in pharmaceutical production and possible solutions to these challenges are discussed.
The course ranges from legal requirements and microbiological principles, sources of contamination, hygiene measures and monitoring to life cycle management of the overall strategy.
The overriding aim of such a system is to prevent microbiological and particulate contamination of the pharmaceutical product. But even if such a system is established, it is of the utmost importance that these programmes and measures are understood and followed by all employees who carry out quality-relevant work. This is why the regulations require intensive training in hygiene issues.
And in the new Annex 1 of the EU GMP guidelines, the overarching integration of the individual measures with the contamination control strategy is now also clearly required.
Against the background of these requirements, this ECA training course is designed to cover all important aspects of microbiological and, to a lesser extent, particulate contamination control. It ranges from the sources of contamination to the validation of cleaning and disinfection processes and the training of operating personnel. Emphasis is placed on the problems frequently encountered in pharmaceutical production and possible solutions to these challenges are discussed.
The course ranges from legal requirements and microbiological principles, sources of contamination, hygiene measures and monitoring to life cycle management of the overall strategy.
Hintergrund
In pharmaceutical production, cleaning and disinfection as well as other hygiene measures are important and decisive process steps to fulfil the quality requirements for the medicinal product. In order to carry them out properly, personnel must be both qualified and motivated.
All national and international pharmaceutical GMP regulations - especially those for sterile manufacturing - require cleaning and hygiene programmes in pharmaceutical companies. The lack of control of microbiological (and other) contamination is a prominent feature of inspection findings. Not all authorities regularly publish overviews or inspection results, but looking at the available data from various inspection authorities over the last 20 years, the following picture emerges:
All national and international pharmaceutical GMP regulations - especially those for sterile manufacturing - require cleaning and hygiene programmes in pharmaceutical companies. The lack of control of microbiological (and other) contamination is a prominent feature of inspection findings. Not all authorities regularly publish overviews or inspection results, but looking at the available data from various inspection authorities over the last 20 years, the following picture emerges:
Between 1995 and 2005, the potential risk of microbiological contamination was the No 2 critical GMP deficiency and the No 1 major GMP deficiency observed during inspections requested by the CHMP/CVMP of EMEA.
MHRA’s review of the deficiencies 2011/2012 issued 57 deficiencies related to personnel as well as 75 contaminations by chemical/physical and microbial causes.
In 2018 and 2019, Annex 1 was the second most frequently mentioned annex of the GMP Guide when it came to deviations in MHRA inspections. Additionally, a suitable Contamination Control Strategy is now mandatory in the revised Version of Annex 1.
A permanent high number of FDA warning letters with microbiological deviations or issues in cleaning and contamination control:
MHRA’s review of the deficiencies 2011/2012 issued 57 deficiencies related to personnel as well as 75 contaminations by chemical/physical and microbial causes.
In 2018 and 2019, Annex 1 was the second most frequently mentioned annex of the GMP Guide when it came to deviations in MHRA inspections. Additionally, a suitable Contamination Control Strategy is now mandatory in the revised Version of Annex 1.
A permanent high number of FDA warning letters with microbiological deviations or issues in cleaning and contamination control:
Fiscal Year 2016 – 23 WL
Fiscal Year 2017 – 24 WL
Fiscal Year 2018 – 16 WL
Fiscal Year 2019 – 32 WL
Fiscal Year 2020 – 25 WL
Fiscal Year 2021 – 36 WL
Fiscal Year 2023 – 28WL
Fiscal Year 2024 – 40 WL
Fiscal Year 2017 – 24 WL
Fiscal Year 2018 – 16 WL
Fiscal Year 2019 – 32 WL
Fiscal Year 2020 – 25 WL
Fiscal Year 2021 – 36 WL
Fiscal Year 2023 – 28WL
Fiscal Year 2024 – 40 WL
This current situation clearly shows how important it is to deal with this issue in depth and also why an overall strategy for linking the various measures plays such an important role.
Zielgruppe
People who are involved in
- Microbial Monitoring
- Implementation of Hygiene Programmes
- Selection and Qualification of Disinfectants
- Handling of microbial Deviations
- Training of Operators for Monitoring
- Responsibilities in Annex 1 Implementation and Contamination Control Strategy
Date / Venue / Presentations / Certificate
Date
Contamination Control:
Tuesday, 04 November 2025, 09.00 – 18.00 h
(Registration and coffee 08.30 – 09.00 h )
Wednesday, 05 November 2025, 08.30 – 18.00 h
Thursday, 06 November 2025, 08.30- 13.30 h
Post-Conference Workshop:
Friday, 07 November 2025, 09.00 – 15.00 h,
(Registration and Coffee 08.30 -09.00 h)
Venue
Barceló Sants Hotel
Plaça dels Països Catalans, s/n
08014 Barcelona, Spain
Phone +34 (93) 503 53 00
Email sants@barcelo.com
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.
Programm
Gesamtes Programm als PDF herunterladen
Module 1: Regulatory Requirements and Background
Basic Principles of Microbiology, Hygiene and Contamination Control
Basic Principles of Microbiology, Hygiene and Contamination Control
- Microorganisms
- Microbial growth
- Characteristics
- Sources
- Basic hygienic cctions
- Cleaning/disinfecting/sterilization
- Way of contamination
Regulatory Requirements
- General regulatory requirements and uidelines
- Prevention of contamination and cross contamination
- Requirements for validation
- ISO standards
- Quality Risk Management
Sources of Contamination and Preventive Measures
- Sources of contamination throughout the facility
- HVAC
- Water
- Raw materials and packaging components
- Personnel and clothing
Effective Training of Operators
- Regulatory requirements (EU-GMP, FDA Guidelines, experiences from inspections)
- Methods and tools
- Measurement and documentation of training success
- Practical approaches
Module 2: Monitoring and Control Strategies
Microbiological Monitoring
Microbiological Monitoring
- 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
Cleanroom Garment - Requirements, Selection and Laundering
- Different fabrics and their characteristics like filtration capacity and wearing comfort
- Garment systems oriented by the cleanroom class
- Requirements on decontamination and laundering
- Outsourcing
- Single-Use consumables
Microbiological Control of Water Systems
- Water as raw material
- Contamination sources within the water system
- Technical aspects
- Control methods
- Microbiological testing of water
Trending of Environmental Monitoring Data
- How do you do it?
- What do the results really tell you?
- How should you react on the results?
- Criteria of selection of disinfectants
- Rotation of antimicrobial substances considering their chemical interaction
- Cleaning potential of disinfectants
- Users' acceptance
Module 3: Cleaning/Disinfection – Measures, Pit Falls, Deviation Handling
Cleaning and Disinfection of Surfaces
- Criteria of selection of disinfectants
- Rotation of antimicrobial substances considering their chemical interaction
- Cleaning potential of disinfectants
- Users acceptance
Qualification of Disinfectants
- Guidance documents, standards and regulatory requirements
- Basis for qualification
- Case study for qualification of disinfectants
- Efficacy – how to control?
Hygiene of Personnel – Cleanroom Behaviour
- Contamination from personnel
- Classic employee deviance
- Gowning procedure
- Hand disinfection
Case Study: Managing Disinfection Programmes
- Hygiene Programme
- Cleanroom Concept
- Demands on environment, equipment and personnel
- Cleaning and disinfection concept
Validation of a Decontamination System for Production Equipment, Process Devices and Cleanrooms
- Technical requirements & background
- Qualification of a fogging system
- Validation of a fogging process
Parallel Workshops
During the second day, parallel workshops will be conducted in order to reinforce the content of the lectures and to discuss practical aspects in detail.
Workshops will be offered on the following topics:
Workshops will be offered on the following topics:
- Case Studies: Disinfections Issues
Practical examples of microbial deviations after cleaning and disinfection activities. Causes, faults and correcting actions. - Handling of OOS Results
Failure investigation, following corrective actions and preventive Actions.
Module 4: Additional Challenges and Annex 1-compliant Overarching Strategies
Cleanroom Consumables - a so called „Cent-Product“, but with Consequences
Cleanroom Consumables - a so called „Cent-Product“, but with Consequences
- Definition of cleanroom consumable products
- The impact during the daily application
- How is that reflected in guidelines?
Quality Risk Management
- Risk assessment:
- Risk identification
- Risk analysis
- Risk evaluation
- Risk management
Contamination Control Strategy - An Interdisciplinary and Dynamic System
- Formulate a CCS
- Implement a CCS and develop a strategic plan to make the strategy work as intended by mapping/designing the organizational structure, procedures, control processes, distributing resources, developing the decision-making processes, etc.
- Evaluate the CCS efficiency to ensure process performance and product quality while improving the CCS level over time.
| ECA-Member*: | € 2290,- |
| Non ECA Member*: | € 2490,- |
| EU/GMP Inspectorates*: | € 1245,- |
| APIC Member Discount*: | € 2390,- |
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
This course is part of the GMP Certification Programme "ECA Certified Microbiological Laboratory Manager"
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E-Mail: info@concept-heidelberg.de
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