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
Zielsetzung
In most cases the implementation of appropriate hygiene programmes and measures have been implemented as an essential part for the manufacturing of pharmaceutical products. A series of regulations address the subject of microbiological facility control but GMP requirements are mostly described in more general terms. But how can they be introduced in pharmaceutical companies in a practice-oriented way? What is state-of–the-art? How should detergents and disinfectants be used?
The overall goal of such a system is to prevent microbiological contamination of the pharmaceutical product. But even if such a system has been established, it is of utmost importance that these programmes and measures are understood and followed by all operators who carry out quality-relevant work. Therefore, regulations demand intensive training in hygiene issues.
Against the background of these requirements, this Live Online Training is designed to cover all important aspects of controlling microbiological contamination. It ranges from sources of contamination to validation of cleaning and disinfection processes and training of operators. A focus will be on those problems that occur frequently in pharmaceutical production; possible solutions to these challenges will be discussed.
The course ranges from regulatory requirements and microbiological basics, sources of contamination, hygiene measures and monitoring to life cycle management of the overall strategy.
The overall goal of such a system is to prevent microbiological contamination of the pharmaceutical product. But even if such a system has been established, it is of utmost importance that these programmes and measures are understood and followed by all operators who carry out quality-relevant work. Therefore, regulations demand intensive training in hygiene issues.
Against the background of these requirements, this Live Online Training is designed to cover all important aspects of controlling microbiological contamination. It ranges from sources of contamination to validation of cleaning and disinfection processes and training of operators. A focus will be on those problems that occur frequently in pharmaceutical production; possible solutions to these challenges will be discussed.
The course ranges from regulatory requirements and microbiological basics, sources of contamination, hygiene measures and monitoring to life cycle management of the overall strategy.
Hintergrund
The lack of control of microbiological contamination is an outstanding integral part of inspection findings. Not all authorities regularly publish overviews or inspection results, but if one looks at the available data of the last 20 years from various inspection authorities, the following picture emerges:
Between 1995 – 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.
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
Between 1995 – 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.
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
This actual state clearly demonstrates the importance to concern oneself with this topic in Detail.
In pharmaceutical manufacture, cleaning and disinfection measures are important and decisive process steps for fulfilling the quality requirements on the medicinal product. To carry them out properly, personnel needs to be both qualified and motivated.
All national and international pharmaceutical GMP regulations - especially those on sterile manufacturing - call for cleaning and hygiene programmes in the pharmaceutical companies.
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
Technical Details:
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Programm
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 actions
- Cleaning/disinfecting/sterilization
- Way of contamination
Regulatory Requirements
- General regulatory requirements and Guidelines
- 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
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?
Module 3: Cleaning/Disinfection – Measures, Pit Falls , Deviation Handling
Cleaning and Disinfection of Surfaces
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
- Different gassing Systems
- 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
Case Studies: Disinfections Issues
- Practical examples of microbial deviations after cleaning and disinfection activities
- Root causes and pitfalls
- Measures for troubleshooting in practice
- Preventive measures to avoid errors
Handling of Microbiological OOS/OOL Results
- Failure investigation
- Following corrective actions and preventive actions
Module 4: Further Challenges – Garment, Single Use Consumables and More
Cleanroom Garment, Requirements, Selection and Laundering
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
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
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?
Module 5: Overarching Considerations of Importance
Quality Risk Management
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
Recording from 9/11 November 2022
Duration of Recording: 16 h 30 min
| ECA-Member*: | € 1890,- |
| Regular Fee*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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This course is part of the GMP Certification Programme "ECA Certified Microbiological Laboratory Manager"
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