Contamination Control - Requirements, Measures and Strategy - Online Training Recording
Course No. 20287A
Speakers
Werner Hofstetter
Octapharma
Robert G. Schwarz
GXP-TrainCon
Dr Inga-Marie Schlägl
GP Grenzach Produktions GmbH
Carsten Moschner
CMC3
Arjan Langen
MSD
Wolf-Dieter Wanner
Consultant
Walid El Azab
QP Pro Services
Objectives
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.
Background
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
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.
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
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.
Programme
Module 1: Regulatory Requirements and Background
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)
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
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
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
This course is part of the GMP Certification Programme "ECA Certified Microbiological Laboratory Manager" Learn more
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