GMP Certification Programme

Certified Sterile Production Manager

Environmental Monitoring
Speakers

Compliant and Reasonable

Arjan Langen
GE Healthcare, The Netherlands

Live Online Training on 26/27 May 2021

Chris Randell
CooperVision, UK

Dr Björn Wiese
Zimmer Biomet GmbH, Switzerland

Highlights
ƒ Environmental Monitoring. Why Do We Do It – What Does it Tell Us?
ƒ Relevant Guidelines Including EU GMP Annex 1 Revision
ƒ Non-viable (particulate) Air Monitoring
ƒ Environmental Monitoring for Non-Steriles
ƒ Clean Rooms - RABS - Isolator: Points to Consider
ƒ Surface | Personnel | Air Monitoring
ƒ Deviation Management for Environmental Monitoring
ƒ Microbiological Methods
ƒ Investigations | Documentation | Trending

Workshops / Case Studies:

- How to Establish an Environmental
Monitoring Programme
- Interpretation of OOS Results
- Trending of Environmental
Monitoring Results
Programme

Objectives Programme
Environmental monitoring is one of the systems that decide Environmental Monitoring
about the product quality in the manufacture of sterile medicinal
products. Both European and American GMP regulations place ƒ Why do we do it – what does it tell us?
special focus on this topic.
Relevant Guidelines
The USP 1116, the EU GMP Annex 1 (under revision) and especial-
ly the FDA’s “Guidance for Industry: Sterile Drug Products Pro- ƒ EU-GMP Guide Annex 1 (Revision)
duced by Aseptic Processing - Current Good Manufacturing Prac- ƒ SP <1116>
U
tice“ deal in detail with environmental monitoring. ƒ FDA Aseptic Processing Guide
ƒ ISO 14644 and ISO13824
However, many of the requirements laid down in these docu- ƒ An overview about the most important guidances
ments seem to be excessive for everyday practice on the one
hand and leave great scope for interpretation on the other hand. Surface / Personnel Monitoring

ƒ Surface:
- ­ How?
- ­ Surface sampling techniques
- ­ Limitations
- ­ Validation?
ƒ Personnel:
- ­ When and how?
- ­ Results and specifications
- ­ How to deal with shedders/pathogen carriers.

Viable Air Monitoring

ƒ R egulatory Standards
Picture: Heipha
ƒ Settle Plates
- Validation
In practice, environmental monitoring programmes sometimes - Drying Issues
develop into time-consuming, cost- and personnel-intensive - Where to place them?
measures. Therefore, it is the aim of this Live Online Training to ƒ Active Air Sampling
provide the participants with pragmatic recommendations for - Equipment options / comparison
the creation and implementation of environmental monitoring - Validation
programmes. - Where to place them?

Within the framework of this Live Online Training, the partici- Clean Rooms – RABS – Isolator: Points to consider in
pants are confronted with current hot topics, like: Environmental Monitoring

ƒ Alert / action levels ƒ Comparison of the technical concepts

ƒ Relationship to batch release ƒ alidation of microbiological media for the isolator
V
ƒ Locations and frequency ƒ Selection of sampling points
ƒ Identification of isolates ƒ Transfer of microbiological media
ƒ Sampling procedures ƒ Interpretation of the results and handling of excursions
and get to know solutions for their own company practice.
Non-viable (particulate) Air Monitoring

Target Audience ƒ Th
e grading of areas for manufacture of sterile medicinal
products in the EU
This Live Online Training is directed at staff from Production, ƒ How to claim classification of areas to current standards
Quality Assurance and Quality Control who is responsible for the ƒ How to ensure continuing compliance with the
planning and implementation of environmental monitoring pro- classification
grammes. It is also valuable for decision makers who have to deal ƒ Selection of sampling locations for qualification and
with environmental monitoring data within the framework of routine
product release. ƒ Particle monitoring, how and how often
ƒ Handling the data

Environmental Monitoring | Live Online Training on 26/27 May 2021

 Speakers

Workshop / Case Study Workshop / Case Study

How to Establish an Environmental Monitoring Interpretation of OOS Results

Programme / Use of FMEA to Determine Sample Points in ƒ What is an OOS in environmental monitoring?
Routine Monitoring ƒ OOS in relation to trends
ƒ Identifying weaknesses in contamination control ƒ How to investigate
systems ƒ Follow-up and corrective actions
ƒ Identifying locations which will provide “early ƒ Consequences for batch release
warning” signals of loss of control
ƒ Preparing useful environmental monitoring SOPs
ƒ Keeping manageable records
Investigations / Documentation

ƒ Th
e information content of “variable” data versus
quantitative limits
Case Study ƒ Published and practical limits
ƒ The information content of qualitative data
Trending of Environmental Monitoring Data
ƒ Communicating with technical management and higher
ƒ What is a trend?
management
ƒ How can I use electronic systems to track and trend
EM data?
ƒ How to get meaningful information from trending
ƒ Alert and action level setting
ƒ Using trending as tool for pro-active environmental
Speakers
control measures
Arjan Langen
GE Healthcare, The Netherlands
Microbiological Methods
Arjan Langen has over 20 years of experience within the field of
ƒ icrobiological media, growth requirements
M pharmaceutical microbiology. Currently he is a Director Sterility
ƒ Identification of isolates Assurance at GE Healthcare, responsible for the global Sterility
ƒ Validating your methods Assurance program. Besides he is a member of the ECA Annex 1
ƒ Using rapid identification techniques task force that works on the detailed review of the draft revision
ƒ Recovery problems text of Annex 1. He is microbiologist by training, qualified IRCA/
ƒ Identification to the level of DNA, what value does it bring QCI auditor and Green Belt certified.

Environmental Monitoring for Medical Devices

ƒ E nvironmental Monitoring requirements considering Chris Randell

ISO and AAMI CooperVision, Eastleigh, UK
- Classified Cleanrooms
- Controlled Environment Chris has been working in the pharmaceutical and medical device
ƒ Real life example industry for over 27 years. He has vast experience in both sterile
ƒ What to do when excursions occur? and non-sterile pharmaceutical manufacturing environments as a
microbiologist and as a quality assurance manager at Wyeth/Pfi-
Environmental Monitoring for Non-Steriles zer. Currently he is Senior QA Manager for CooperVision.

ƒ Why monitor non-sterile areas

ƒ isk vs impact
R Dr Björn Wiese
ƒ Overview of regulatory position Zimmer Biomet GmbH, Winterthur,
ƒ Case study Switzerland

Deviation Management for Environmental From 1996 to 2010 Björn Wiese worked in microbiology depart-
Monitoring ments i.a. at Hameln Pharmaceuticals, Hameln, Germany and Ci-
lag in Schaffhausen, Switzerland. 2011 he joined Zimmer GmbH
ƒ Steps to be taken in case of excursions now as Director Sterilization Technology and Analytical Testing.
ƒ hen is an excursion a deviation?
W
ƒ Comprehensive root cause analysis
ƒ The nasty “re-occurrence”
ƒ Finding of appropriate actions

Environmental Monitoring | Live Online Training on 26/27 May 2021

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