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.
Background
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.
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:
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.
Target Group
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
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.
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
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
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:
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
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.
This course is part of the GMP Certification Programme "ECA Certified Microbiological Laboratory Manager" Learn more
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