Robert G. Schwarz
GXP-TrainCon
Referent:innen
Arjan Langen
GE Healthcare
Carsten Moschner
CMC3
Walid El Azab
QP Pro Services
Werner Hofstetter
Octapharma
Wolf-Dieter Wanner
Consultant
Dr. Marcel Goverde
MGP Consulting
Zielsetzung
Contamination Control Strategies
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.
And in the new Annex 1, the overarching interlinking of the individual measures is now also clearly required with the Contamination Control Strategy.
Against the background of these requirements, this ECA education course 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.
And in the new Annex 1, the overarching interlinking of the individual measures is now also clearly required with the Contamination Control Strategy.
Against the background of these requirements, this ECA education course 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.
Post-Conference Workshop "Risk Assessment in Contamination Control"
From ICH to Annex 1 – Risk Evaluation as a Part of Contamination Control Strategies
From ICH to Annex 1 – Risk Evaluation as a Part of Contamination Control Strategies
Risk-based approaches have gained considerably in importance in all branches in recent years. Pharmaceutical production, quality assurance and quality control would be unthinkable without them. Starting with the FDA initiative “cGMPs for the 21st Century” for the introduction of the risk-based approach, through the subsequent ICHQ9 guideline on risk management, which can now be found as Part III of the EU GMP guidelines, to the revised Annex 15 with a wealth of risk analyses, these principles are anchored everywhere. With the revision of Annex 1, risk management is also increasingly becoming part of the main guideline for the manufacture of sterile pharmaceutical products.
In this workshop on the principles, regulations and application of risk assessment in the context of contamination control, you will gain insight into the relevant underlying guidelines and guides as well as valuable pointers for practical implementation using practical examples. The following areas are covered:
- General introduction on risk assessments
- ICH Q8, Q9 and Q10 principles
- How to apply risk assessments in contamination Control
- Example of a Contamination Control Strategy
- Interactive session: FMEA
Hintergrund
In pharmaceutical manufacture, cleaning and disinfection and other hygienic 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.
The lack of control of microbiological (and other) contamination is an outstanding integral part of inspection findings.
All national and international pharmaceutical GMP regulations — especially those on sterile manufacturing — call for cleaning and hygiene programmes in the pharmaceutical companies.
The lack of control of microbiological (and other) 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 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.
A permanent high number of FDA warning letters with microbiological deviations or issues in cleaning and contamination control:
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.
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 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.
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 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
Contamination Control Strategies
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
Post-Conference Workshop "Risk Assessment in Contamination Control"
The workshop is designed for personnel of pharmaceutical companies, their suppliers and representatives of authorities with responsibilities in Contamination Control, Aseptic Manufacturing, Quality Assurance, Quality Control, Internal Quality Audits, External Inspections.
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.
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 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
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
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
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.
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
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.
Post-Conference Workshop "Risk Assessment in Contamination Control"
From ICH to Annex 1 – Risk Evaluation as Part of Contamination Control Strategies
General Introduction on Risk Assessments
- Principles of ICH Q9
- Patient safety and product quality
- Dos and don’ts
- Tools and Methods
ICH Q8, Q9 and Q10 Principles
- Quality by Design (QbD)
- Criticality of quality attributes and process parameters
- Control strategy life cycle
- Knowledge management
How to apply Risk Assessments in Contamination Control
- Pro-active vs. reactive
- FMEA for equipment and processes
- Risk assessments for impact assessments
- HACCP for contamination control
Example of a Contamination Control Strategy
- Contamination control master file
- Reference document
- Annual report
Short Interactive Session (Participants do an FMEA on a Certain Topic)
- Executing an FMEA (on a sterilizer or isolator)
- Evaluation – what went well and what were the challenges?
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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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