GMP Certification Programme

Certified Microbiological Laboratory Manager

Speakers
Contamination Control Strategies
Requirements, Measures and Strategies
05 - 07 November 2024, Berlin, Germany
Walid El Azab
QP Pro Services, Belgium
with an optional Post-Conference Workshop „Risk Assessment in
Contamination Control“ on 08 November 2024, Berlin, Germany

Dr Marcel Goverde
MGP Consulting, Switzerland

Werner Hofstetter
Octapharma, Austria

Arjan Langen

Image: HEIPHA Dr. Müller

GE Healthcare, The Netherlands

This course will provide practice-oriented

guidance and includes practical workshops
and case studies
Carsten Moschner
CMC3, Germany
Highlights
ƒ Regulatory Requirements, incl. Annex 1
ƒ Principles of Hygiene and Microbiology
ƒ Disinfectants: Characteristics, Selection and Qualification
Axel Schroeder ƒ Sources of Contamination and Preventive Measures
Concept Heidelberg, Germany ƒ Microbiological Monitoring and Trending
ƒ Risk Management
ƒ Handling of OOS Results
ƒ Cleanroom Garment and Single-Use Consumables
ƒ Hygiene of Personnel and Training of Operators
ƒ Contamination Control Strategy – a Dynamic System
Robert G. Schwarz
GxP TrainCon, Austria
Highlights Post-Conference Workshop
ƒ ICH Q8, Q9 and Q10 Principles
ƒ How to apply Risk Assessment in Contamination Control
ƒ Example of a Contamination Control Strategy
Wolf-Dieter Wanner ƒ Short Interactive Session (Participants do an FMEA on a Certain Topic)
Germany
Programme

Objective
Between 1995 and 2005, the potential risk of microbiologi-
In most cases the implementation of appropriate hygiene pro- cal contamination was the No 2 critical GMP deficiency and
grammes and measures have been implemented as an essential the No 1 major GMP deficiency observed during inspec-
part for the manufacturing of pharmaceutical products. A series tions requested by the CHMP/CVMP of EMEA.
of regulations address the subject of microbiological facility con-
trol but GMP requirements are mostly described in more general MHRA’s review of the deficiencies 2011/2012 issued 57 de-
terms. But how can they be introduced in pharmaceutical com- ficiencies related to personnel as well as 75 contamina-
panies in a practice-oriented way? What is state-of–the-art? tions by chemical/physical and microbial causes.
How should detergents and disinfectants be used?
In 2018 and 2019, Annex 1 was the second most frequently
The overall goal of such a system is to prevent microbiological mentioned annex of the GMP Guide when it came to devia-
contamination of the pharmaceutical product. But even if such a tions in MHRA inspections.
system has been established, it is of utmost importance that
these programmes and measures are understood and followed A permanent high number of FDA warning letters with
by all operators who carry out quality-relevant work. Therefore, microbiological deviations or issues in cleaning and con-
regulations demand intensive training in hygiene issues. tamination control:

And in the new Annex 1, the overarching interlinking of the indi- Fiscal Year 2016 - 23 WL
vidual measures is now also clearly required with the Contami- Fiscal Year 2017 - 24 WL
nation Control Strategy. Fiscal Year 2018 - 16 WL
Fiscal Year 2019 - 32 WL
Against the background of these requirements, this ECA educa- Fiscal Year 2020 - 25 WL
tion course is designed to cover all important aspects of control- Fiscal Year 2021 - 36 WL
ling microbiological contamination. It ranges from sources of
contamination to validation of cleaning and disinfection pro-
cesses and training of operators. A focus will be on those prob-
lems that occur frequently in pharmaceutical production; possi- This current situation clearly shows how important it is to deal
ble solutions to these challenges will be discussed. with this issue in depth and also why an overall strategy for link-
ing the various measures plays such an important role.
The course ranges from regulatory requirements and microbio-
logical basics, sources of contamination, hygiene measures and
monitoring to life cycle management of the overall strategy.
Target Audience
Background People who are involved in
ƒ Microbial Monitoring
In pharmaceutical manufacture, cleaning and disinfection and ƒ Implementation of Hygiene Programmes
other hygienic measures are important and decisive process ƒ Selection and Qualification of Disinfectants
steps for fulfilling the quality requirements on the medicinal ƒ Handling of microbial Deviations
product. To carry them out properly, personnel needs to be both ƒ Training of Operators for Monitoring
qualified and motivated.

All national and international pharmaceutical GMP regulations

— especially those on sterile manufacturing — call for cleaning Moderator
and hygiene programmes in the pharmaceutical companies.
Axel H. Schroeder, Concept Heidelberg
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 re- Social Event
sults, but if one looks at the available data of the last 20 years
from various inspection authorities, the following picture emerg- In the evening of the first course day, you
es: are cordially invited to a social event.
This is an excellent opportunity to share
your experiences with colleagues from
other companies in a relaxed atmos-
phere.

Contamination Control Strategies & Post-Conference Workshop | 05 - 08 November 2024, Berlin, Germany
Programme Microbiological Control of Water Systems

Module 1: Regulatory Requirements and Background ƒ Water as raw material

ƒ Contamination sources within the water system
Basic Principles of Microbiology, Hygiene and ƒ Technical aspects
Contamination Control ƒ Control methods
ƒ Microbiological testing of water
ƒ Microorganisms
- Microbial growth Trending of Environmental Monitoring Data
- Characteristics
- Sources ƒ How do you do it?
ƒ Basic hygienic actions ƒ What do the results really tell you?
ƒ Cleaning/disinfecting/sterilization ƒ How should you react on the results?
ƒ Way of contamination ƒ Criteria of selection of disinfectants
ƒ Rotation of antimicrobial substances considering their
Regulatory Requirements chemical interaction
ƒ Cleaning potential of disinfectants
ƒ General regulatory requirements and guidelines ƒ Users acceptance
ƒ Prevention of contamination and cross contamination
ƒ Requirements for validation
ƒ ISO standards Module 3: Cleaning/Disinfection – Measures,
ƒ Quality Risk Management Pit Falls, Deviation Handling

Sources of Contamination and Preventive Measures Cleaning and Disinfection of Surfaces

ƒ Sources of contamination throughout the facility ƒ Criteria of selection of disinfectants

ƒ HVAC ƒ Rotation of antimicrobial substances considering
ƒ Water their chemical interaction
ƒ Raw materials and packaging components ƒ Cleaning potential of disinfectants
ƒ Personnel and clothing ƒ Users acceptance

Effective Training of Operators Qualification of Disinfectants

ƒ Regulatory requirements (EU-GMP, FDA Guidelines, ƒ Guidance documents, standards and regulatory
experiences from inspections) requirements
ƒ Methods and tools ƒ Basis for qualification
ƒ Measurement and documentation of training success ƒ Case study for qualification of disinfectants
ƒ Practical approaches ƒ Efficacy – how to control?

Hygiene of Personnel – Cleanroom Behaviour

Module 2: Monitoring and Control Strategies
ƒ Contamination from personnel
Microbiological Monitoring ƒ Classic employee deviance
ƒ Gowning procedure
ƒ Monitoring of non-sterile processes ƒ Hand disinfection
ƒ Aseptic manufacture:
- developing a programme Case Study: Managing Disinfection Programmes
- interpreting data
- regulatory requirements ƒ Hygiene programme
ƒ Monitoring methods, air, surface, people ƒ Cleanroom concept
ƒ A complete programme for a sterile product ƒ Demands on environment, equipment and personnel
ƒ Cleaning and disinfection concept
Cleanroom Garment - Requirements, Selection and
Laundering Validation of a Decontamination System for
Production Equipment, Process Devices and
ƒ Different fabrics and their characteristics like filtration Cleanrooms
capacity and wearing comfort
ƒ Garment systems oriented by the cleanroom class ƒ Technical requirements & background
ƒ Requirements on decontamination and laundering ƒ Qualification of a fogging system
ƒ Outsourcing ƒ Validation of a fogging process

Contamination Control Strategies & Post-Conference Workshop | 05 - 08 November 2024, Berlin, Germany
 Post-Conference Workshop

Risk Assessment in
Parallel Workshops Contamination Control
During the second day, parallel workshops will be con- From ICH to Annex 1 –
ducted in order to reinforce the content of the lectures and Risk Evaluation as a Part of Contamination Control Strategies
to discuss practical aspects in detail.

Workshops will be offered on the following topics: Background and Objectives

1. Case Studies: Disinfections Issues Risk-based approaches have gained considerably in importance
Practical examples of microbial deviations after cleaning in all branches in recent years. Pharmaceutical production, qua-
and disinfection activities. Causes, faults and correcting lity assurance and quality control would be unthinkable wit-
actions. hout them. Starting with the FDA initiative “cGMPs for the 21st
Century” for the introduction of the risk-based approach,
2. Handling of OOS Results through the subsequent ICHQ9 guideline on risk management,
Failure investigation, following corrective actions and which can now be found as Part III of the EU GMP guidelines, to
preventive actions. the revised Annex 15 with a wealth of risk analyses, these prin-
ciples 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 pro-
Module 4: Additional Challenges and ducts.
Annex 1-compliant Overarching Strategies
In this workshop on the principles, regulations and application
Cleanroom Consumables - a so called „Cent of risk assessment in the context of contamination control, you
Product“, but with Consequences will gain insight into the relevant underlying guidelines and
guides as well as valuable pointers for practical implementa-
ƒ Definition of cleanroom consumable products tion using practical examples. The following areas are covered:
ƒ The impact during the daily application
ƒ How is that reflected in guidelines? ƒ General introduction on risk assessments
ƒ ICH Q8, Q9 and Q10 principles
Quality Risk Management ƒ How to apply risk assessments in contamination control
ƒ Example of a Contamination Control Strategy
ƒ Risk assessment: ƒ Interactive session: FMEA
- Risk identification
- Risk analysis
- Risk evaluation Target Group
ƒ Risk management
The workshop is designed for personnel of pharmaceutical
Contamination Control Strategy - companies, their suppliers and representatives of authorities
An interdisciplinary and Dynamic System with responsibilities in Contamination Control, Aseptic Manuf-
acturing, Quality Assurance, Quality Control, Internal Quality
ƒ Formulate a CCS Audits, External Inspections.
ƒ Implement a CCS and develop a strategic plan to make
the strategy work as intended by mapping/designing the
organizational structure, procedures, control processes, Programme
distributing resources, developing the decision-making
processes, etc. General Introduction on Risk Assessments
ƒ Evaluate the CCS efficiency to ensure process perfor-
mance and product quality while improving the CCS level ƒ Principles of ICH Q9
over time. ƒ Patient safety and product quality
ƒ Dos and don’ts
ƒ Tools and methods

ICH Q8, Q9 and Q10 Principles

ƒ Quality by Design (QbD)

ƒ Criticality of quality attributes and process parameters
ƒ Control strategy life cycle
ƒ Knowledge management

Contamination Control Strategies & Post-Conference Workshop | 05 - 08 November 2024, Berlin, Germany
Post-Conference Workshop

How to apply Risk Assessments in Contamination Arjan Langen

Control Director Sterility Assurance, GE Healthcare,
The Netherlands
ƒ Pro-active vs. reactive Arjan Langen has over 20 years of experience within
ƒ FMEA for equipment and processes the field of pharmaceutical microbiology. He worked
ƒ Risk assessments for impact assessments for several pharmaceutical and biotech companies (Nobilon,
ƒ HACCP for contamination control DSM, MSD) and had various local and global roles within QC, QA,
manufacturing and auditing. Currently he is a Director Sterility
Example of a Contamination Control Strategy Assurance at GE Healthcare, responsible for the global Sterility
Assurance program. Besides, he is a member of the ECA Annex 1
ƒ Contamination control master file Task Force and of the Dutch Society of Pharmaceutical Microbi-
ƒ Reference document ology. He is microbiologist by training, qualified IRCA/QCI audi-
ƒ Annual report tor and Green Belt certified.

Short Interactive Session (Participants do an FMEA Carsten Moschner

on a Certain Topic) CMC3, Germany
Carsten Moschner studied engineering economics at
ƒ Executing an FMEA (on a sterilizer or isolator) the University for applied Sciences in Karlsruhe. Un-
ƒ Evaluation – what went well and what were the til 2023, he was owner and CEO of Dastex with a fo-
challenges? cus on research and development as well as optimising of textile
cleanroom garment. Carsten is a member of several expert com-
mittees, e.g. deeply involved in the new VDI 2083 chapter about
the suitability of cleanroom equipment. In 2024 he founds his
Speakers new consulting service CMC3.

Walid El Azab, Co-founder and Managing Axel H. Schroeder

Director, QP Pro Services, Belgium Concept Heidelberg, Germany
Walid, is a senior consultant, specializes in GMP and Axel Schroeder got his degree in Biology at
GDP activities, with a focus on contamination con- Ruprecht-Karls University Heidelberg. From 1994 to
trol, sterility assurance, and inspection readiness. 2000 he was Territory Manager for Hygiene and
Acting as a Qualified Person and Responsible Person, he pos- Medical Devices at Henkel Ecolab GmbH. From 2000 to 2005 he
sesses expertise in non-sterile and sterile processes, including was Key Account Manager for Industrial Hygiene and Contami-
drug substance and product manufacturing. Walid‘s auditing nation Control at Ecolab GmbH, Düsseldorf, and from 2003 to
proficiency covers CMOs, API manufacturers, and suppliers. En- 2005 Member of the International Cleanroom Team of Ecolab.
gaged in professional organizations, he contributes to confe- Between 2005 and 2008 he was engaged at Basan GmbH as Key
rences, and industry guidelines. Committed to education, He is a Account Manager for Pharmaceuticals and Biotechnology. Since
professor at Brussels and Liège University and co-founded the 2008 he is operations director at Concept Heidelberg for micro-
QP Academy. He provides consultancy support through QPM biology and biotechnology.
Consulting and QP Pro Services, acting as a strategic partner for
pharmaceutical industry business continuity. Robert G. Schwarz
GxP TrainCon, Austria
Dr Marcel Goverde Robert Schwarz has a degree in bioprocess engineer-
MGP Consulting, Switzerland ing and biotechnological quality management. From
Marcel Goverde has attended the University of Basel, 2001, he led the environmental monitoring team at Baxter, and
where he majored in biology. 2002 to 2010 he was from 2005 to 2018 he was a validation specialist for device qual-
leading the quality control lab for non-sterile pro- ification, sterilisation validation and cleaning validation. Since
ducts as well as the lab for research & development of microbio- 2010, he has also been passing on his experience as a university
logical methods at F. Hoffmann-La Roche Ltd in Basel. From lecturer. In 2019, he began working as a freelance trainer and
2010-2011he worked as microbiological expert at Novartis. In founded his consulting company GxP-TrainCon in 2022.
2011 he started his own company for consulting, training and
project management in microbiology. Wolf-Dieter Wanner
Germany
Werner Hofstetter Wolf-Dieter Wanner studied pharmacy at the Uni-
Octapharma GmbH, Austria versity of Munich. He started working in a free phar-
After his studies of food- and biotechnology, he was macy and later joined Henkel KGaA in Düsseldorf to establish a
engaged as head of laboratory of waste processing German decontamination business relating to the industry. At
and as department manager at the pharmaceutical Ecolab Deutschland GmbH as a sales manager he integrated the
industry. Since 2002 he is working at the pharmaceutical pro- German clean room business with Adams Healthcare and Shield
duction of Octapharma Pharmazeutika GmbH, Vienna and is, Medicare into an international contamination control team fo-
among other things, responsible for validation of disinfectants cused upon pharmaceutical aseptic manufacturing. Since 2011
and the cleanroom monitoring. Since 2006 he is head of aseptic he works as a freelance consultant.
production at Octapharma.
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Contamination Control Strategies, 05 - 07 November 2024, Berlin, Germany
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