Responsibilities in Annex 1 Implementation and Contamination Control Strategy
Objectives
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.
Background
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:
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:
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
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.
Programme
Module 1: Regulatory Requirements and Background
Basic Principles of Microbiology, Hygiene and Contamination Control
Microorganisms
Microbial growth
Characteristics
Sources
Basic hygienic cctions
Cleaning/disinfecting/sterilization
Way of contamination
Regulatory Requirements for Hygiene and Sanitizing
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: Environment and Personell - 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
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?
Cleanroom Garment, Issues in Selection, Laundering and Logistics
General considertaions
Textile characteristics
New Annex 1/CCS
Suitable undergarement
Disposable vs. reusable
Case Study: Managing Disinfection Programmes
Hygiene Programme
Cleanroom Concept
Demands on environment, equipment and personnel
Cleaning and disinfection concept
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.
Hygiene (and Behavior) of Personnel
Contamination from personnel
Classic employee deviance
Gowning procedure
Hand disinfection
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
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
Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the conference. Reservation should be made directly with the hotel. Early reservation is recommended.
Fees (per delegate, plus VAT) Contamination Control Strategies ECA Members € 2,290 APIC Members € 2,390 Non-ECA Members € 2,490 EU GMP Inspectorates € 1,245 The fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on both days, and all refreshments. VAT is reclaimable.
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.
Conference language The official conference language will be English.
Social Event On the evening of the first course day, the participants are cordially invited to a dinner. This event is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Testimonials
