GMP Certification Programme
Certified Validation Manager
Speakers
Process Validation
in the light of the revised Annex 15 and FDA Requirements
Dr Christopher Burgess
Chair of ECA´s Analytical Quality
Control Group, UK 04/05 October 2022 | Heidelberg, Germany
Klaus Eichmüller
EU Inspector, Germany
Dr Line Lundsberg-Nielsen
NNE, UK
Dr Thomas Schneppe
Bayer Bitterfeld, Germany
FDA and EU:
Assessment - Practical Aspects - Statistical Background
Highlights
EU and FDA View
ractical aspects on DoE
P
Process validation life cycle – how to implement
Statistical background
- Free Download: ECA‘s Good Practice Guide
„Integrated Qualification and Validation“
- Get a free of charge Inspectors Aide memoire on
Process Validation
Programme
Objective Target Audience
With publication of the Guidance for Industry “Process Valida- The addressees of the event are qualified staff charged with or
tion: General Principles and Practices” 2011, the FDA requires a responsible for validation activities, such as commissioners for
new direction. Validation is now a „Life Cycle Process” with 3 validation, heads of quality assurance, department heads, etc. It
stages: also addresses members of validation teams (e.g. engineers,
chemists, pharmacists, microbiologists) as well as representa-
Process Design tives of the plant engineering industry and consultants.
Process Qualification
Continued Process Verification Note: The number of participants is limited to 36 persons.
The focus is on process knowledge and process understanding.
Both should be a result of development and verified in routine Programme
production. The “magic” 3 batches are not mentioned any more.
What is very important nowadays is the term „scientific sound“, FDA Thinking
and explicit statistics are mentioned. Six Sigma elements (e.g.
Design of Experiments, DoE) are also mentioned directly or indi- How the concept of Process Validation is about to change
rectly. There is a new stage in routine production called „contin- Ongoing changes in the Quality Management philosophy
ued process verification“. Real-life examples
With the revision of Annex 15 EU GMP Guide in 2015 the EU is The Current EU Approach on Process Validation
going in the same direction: Validation is a lifecycle with phar-
maceutical development as basis and also a stage 3 is men- Process validation in EU guidelines
tioned, called Ongoing Process Verification. In Europe 3 valida- What has changed?
tion approaches are now possible – traditional, continuous and - Revision of Chapter 1 EU GMP Guide
hybrid. - EMA´s Guidance Process Validation
- Annex 15 revision
How can the new requirements be achieved? Excursion QbD
How fit the FDA requirements into European guidelines Excursion Legacy Products
and vice versa? The future of process validation
How can process knowledge and process understanding
be demonstrated on the basis of development studies? Background and Environment of Process Validation:
When is a process valid now? Industry View
Which parameters can be used for knowledge and
understanding studies? Process Validation in guidelines – history
How can „continued/ongoing process verification” The FDA Process Validation Guidance –an overview
be realised? European perspective
How can statistics help? - Annex 15 revision
These questions are discussed, and the possibilities for imple- Case Study Process Validation
mentation are covered.
Role of SOP in the company QM System
How to deal with the established 3 batch approach?
Background Key aspects (Preconditions, Stages 1-3, Review)
Further deliverables from the data and link to other
Since 1987 the FDA Guideline on Process Validation has been the company SOPs
basis for qualification and validation. Within the FDA programme
“Pharmaceutical cGMPs for the 21st Century” there was an an- Basics on Statistics
nouncement for a revision of the guideline. A FDA Policy Guide of
2004 gives some hints to the new validation approach. In No- An overview about statistical aspects
vember 2008 the “Guidance for Industry Process Validation: What statistics do you need for modern Process
General Principles and Practices” was published as a draft and Validation?
came into operation in January 2011. That is now FDA’s „current
thinking“. The chapter 1 of the EU GMP Guide gives hints for Process Design
more emphasises on process capabilities and varieties within
process validation also in Europe.EMA´s Process Validation Quality by Design and how it is an enabler for Process
Guidance and also the revised Annex 15 which came into force on Design
1 October 2015 takes a life cycle approach to process validation.
Process Validation in the light of the revised Annex 15 and FDA Requirements
Speakers
Systems and Tools for Gaining Process Understanding Speakers
and Establishing the Appropriate Control Strategy
Dr Christopher Burgess, Burgess Analytical
Quality Risk Management Consultancy, Barnard Castle, UK
Process Analytical Technology Chris Burgess is an elected member of the USP Council of Ex-
Design of Experiments (including a practical factorial perts on General Chapters, 2010-2015 and member of the Quali-
design for establishing the design space or the operating fied Person Association Advisory Board. During his time in indus-
ranges for the process) try he worked mainly for Glaxo (now GSK) in Quality Control,
How the process design is reflected in the control strategy Quality Assurance and Analytical R&D positions.He has recently
Applying control strategy for stage 2, process qualification been appointed as Visiting Professor at the Strathclyde Institute
and process validation of Pharmacy and Biomedical Sciences (SIPBS) within the Univer-
sity of Strathclyde’s Faculty of Science.
Klaus Eichmüller, Wolnzach c/o Regional Council
Darmstadt, GMP Inspectorate, Germany
Workshop DoE After working in the pharmaceutical Industry Klaus Eichmüller
joined the District Government of Upper Bavaria in Munich.
The delegates examine a process flow diagram and gene- Since 1996 he is working in the field of GMP Inspections of man-
rate an Ishikawa diagram to identify critical elements. ufacturer of medicinal products and importers. He was Deputy
Head of the Central Authority for Supervision of Medicinal Prod-
ucts in Bavaria“ as long as it existed and is now Head of the In-
spectorate for Drug Products, APIs, Blood Products and Tissues
Performance Qualification Approach in Hesse since March 2014.
Design & qualification of facility, utilities & equipment Dr Line Lundsberg-Nielsen, NNE, U.K.
Performance qualification approach Dr Line Lundsberg-Nielsen is a Global Technology Partner at
Performance qualification protocol NNE. She has many years of experience within the pharmaceuti-
Documenting the quality baseline cal Industry and has a theoretical as well as practical approach
to QbD, PAT and RTRT from working at Novo Nordisk and Lund-
beck before being a consultant. Dr Lundsberg is an active ISPE
member and has had different chairing roles supporting QbD,
PAT and PV implementation. She has practical experiences from
PPQ Workshop interaction with the FDA and EMA on QbD, PAT and RTRT as-
pects.
The delegates make a statistical evaluation of validation
data (e.g. trend analysis, Cpk). Dr Thomas Schneppe, Bayer Bitterfeld GmbH ,
Germany
Thomas has more than 30 years GMP experience in Pharmaceu-
Continued/Ongoing Process Verification tical Industry: Qualified Person, Mgmt. Training, GMP Projects,
Operational Excellence in different functions at Klöckner Penta-
Process mapping & critical process variables pack, Schering AG, Asche AG, Bayer AG and actually Bayer Bitter-
Process data collection and collation feld GmbH.
Trend analysis & Statistical Process Control
Deviation management & CAPA
Change management Social Event
Management’s role in Process Validation
In the evening of 04 October, you are cordially invited to a social
event. This is an excellent opportunity to share your experiences
with colleagues from other companies in a relaxed atmosphere.
Continued/Ongoing Process Verification
Workshop
The delegates make a High Level Risk Assessment to ana-
lyze where they are going to focus in process verification.
Process Validation in the light of the revised Annex 15 and FDA Requirements
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Process Validation in the light of the revised Annex 15 and FDA Requirements
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(Registration and coffee 09.00 - 09.30 h)
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Tuesday, 04 October 2022, 09.30 - 18.00 h
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