ISPE NORDIC
CONFERENCE
STOCKHOLM, SWEDEN
26 th MAY 2016
ÅF BUILDING, FRÖSUNDALEDEN 2, 169 99 SOLNA.
EU GMP Annex 15
Qualification & Validation and Continuous Process Verification
Prepare yourself for tomorrow’s
pharmaceutical production
In October 2015 the revised EU GMP Annex 15 regarding Qualification and Validation was released.
This ISPE Nordic seminar will highlight the changes from a regulatory perspective.
The seminar will also present Continuous Process Verification (CPV) and how this is approached by
our industry. During the conference, you will be given the opportunity to see and learn from others
who have implemented the new requirements in a production environment.
The seminar will be held in Stockholm May 26, and is one of few opportunities in the area to
objectively learn more about a new mandatory regulation we all must adapt to.
The ISPE PQLI® Guide: Part 4
The ISPE PQLI® Guide: Part 4 – Process Performance and Product Quality
Monitoring System serves as practical how-to guidance with examples of
technical and scientific methodology for adopting a process performance and
product quality monitoring system (PP&PQMS) in line with the expectations
of ICH Q10, Pharmaceutical Quality System.
By establishing a PP&PQMS, your company can improve opportunities to:
•
Maintain compliance with global regulations
•
Improve confidence that a process runs as intended
The Guide introduces the role of Quality Steward as an owner of product
quality. Responsibilities of the role are discussed for this new concept
emerging from industry
This PQLI Guide is relevant for:
•
New and existing products
•
Small and large molecule
•
All phases of product lifecycle, from development through product discontinuation
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Conference program 26 May 2016
08:00-08:30
Registration and Coffee
08:30-08:45
Welcome and introduction
08:45-09:45
General update and requirements of Annex 15 and CPV
Inger Jönebring, Senior GMP Consultant, MedIQ Consulting AB
09:45-10:45
Seamless integration of ASTM E2500, Annex 15, FDA Process Validation Guid
line and Chinese GMP in large CapEx project in China
Daniel Nilsson, Senior Management Consultant, Aregab AB
10:45-11:00
Network break
11:00-12:00
The Real Challenge of Annex 15 – Continuous Process Verification: Case Study
Dr. Lorenz Liesum, Lead Process Analytical Technology (PAT), Novartis Pharma AG
12:00-12:30
Lunch
12:30-13:30
The bridge between the traditional and a new live cycle validation approach
and the way to the continuous process verification
Timur Güvercinci, Head of Validation, Qualification & Engineering, Merck KGaA
13:30-14:30
Designing a Risk Based, Efficient Approach to Ongoing/Continued Process Verification
Tara Scherder, Managing Director, Arlenda Inc.
14:30-14:45
Network break
14:45-15:45
Implementing CVP in smaller organisations
Monica Hueg/ Vibeke Brun Jensen, NNE Pharmaplan
15:45-16:00
Short Wrap Up
16:00-17:00
Networking – refreshments and snacks
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About the presentations
General update and requirements of Annex 15 and CPV
Inger Jönebring, Senior GMP Consultant, MedIQ Consulting AB
EurdraLex Volume 4, Annex 15 “Qualification and Validation” has been updated and was effected 1
October 2015. The previous version of Annex 15 of the EU Guide to GMP was published in September
2001, and since then there have been significant changes in the GMP environment and there have
been advancements in manufacturing technology and continuous manufacture processes. Guidelines
from the International Conference on Harmonisation (ICH), US FDA Guide on Process Validation, as
well as the approaches in ASTM E2500-07 “Standard Guide for Specification, Design, and Verification
of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment” have also justified
the change.
This presentation will give you the major changes and additional section in the updated version of
Annex 15.
Seamless integration of ASTM E2500, Annex 15, FDA Process Validation Guideline
and Chinese GMP in large CapEx project in China
Daniel Nilsson, Senior Management Consultant, Aregab AB
Previously very few pharmaceutical manufacturers in China have aimed to launch their products
in EU or the US. This situation is changing rapidly. This case study presents a case where a new
facility for a biosimilar product has been designed, built, qualified and validated with state-of-theart risk management methods to US and EU standards, probably for the first time in China. In order
to achieve this, a seamless project execution model was developed to span the entire process life
cycle, from process design through validation and continued (and continuous) process verification.
Throughout this project it became evident that there are challenges in deploying quality risk
management in an emerging market. It also became evident that modern approaches to validation
are effective leadership tools and can help establish a corporate quality culture.
The Real Challenge of Annex 15 – Continuous Process Verification: Case Study
Dr. Lorenz Liesum, Lead Process Analytical Technology (PAT), Novartis Pharma AG
“Annex 15 offers continuous process verification as an alternative approach for process validation. As
prerequisites for this alternative the guideline mentions one of hand product development according
to QbD principle and on the other hand a science based control strategy with a recommendation to
make use of process analytical technology tools.
In this case study, the validation approach of the process and the related control strategy will be
presented. Furthermore life cycle management aspects as maintenance and change control will be
highlighted.
In the context of life cycle management, strategies for ongoing process verification will be elaborated.”
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About the presentations
The bridge between the traditional and a new live cycle validation approach and
the way to the continuous process verification
Timur Güvercinci, Head of Validation, Qualification & Engineering, Merck KGaA
In the last 10 years the work of the International Council for Harmonization (ICH) had a huge
influence to specific processes in the pharmaceutical industry, like the Quality Guidelines Q8
Pharmaceutical Development, Q9 Quality Risk Management and Q10 Pharmaceutical Quality for
the process validation. The US and the EU authorities reacted with the rework of their requirements
for process validation. The most of the pharmaceutical companies go true several lesson and learn
activities to reach the knowledge for the adjustment of their processes, systems and facilities to fulfill
these requirements.
Designing a Risk Based, Efficient Approach to Ongoing/Continued Process Verification
Tara Scherder, Managing Director, Arlenda Inc.
To improve the likelihood of a successful monitoring program, it is critical that manufacturers focus
on the real goals and understand how it is more than a textbook case of control charts. Otherwise,
the process can become unnecessarily complex, requiring an unwarranted and unsustainable
amount of resources. Ongoing monitoring is then seen as a business burden, instead of a process
with real potential for both patient and business benefit. In this session, critical characteristics of
pharmaceutical manufacturing data that must be understood to avoid wasteful over-complication
or overreaction are discussed. These are presented within a framework for a risk based and efficient
approach to the design and interpretation of control charts, parameter choice, and monitoring
frequency. The mindset of both manufacturers and health authorities necessary to achieve the real
goals of ongoing monitoring is explored.
Implementing CVP in smaller organisations
Monica Hueg/ Vibeke Brun Jensen, NNE Pharmaplan
FDA’s “Guidance for Industry Process Validation: General Principles and Practices” was drafted in
November 2008 and was in force in January 2011. The document conveys FDA’s current thinking on
validation. EMA’s “Guideline on process validation for finished product – information and data to
be provided in regulatory submissions” was drafted in February 2012 and was in force in February
2014. Keynotes for both guidance documents are: Process validation, continuous process verification
(CPV), on-going process verification (OPV), critical process parameter, critical quality attribute,
manufacturing process lifecycle and change control.
It is expected by both regulatory bodies that these concepts and principles are implemented by
the manufactures, but it seems, as there is some resistance in the industry for implementing these
concepts and principles. The regulatory bodies had tried to make the validation process operational
and data driven, but why has it then become so complex and difficult to implement CPV/OPV? – is
it because there are differences in expectations? Or is it just difficult to change the mindset and
behavior?
The question is therefore how can these requirements be achieved? The presentation gives an
example from a smaller non-US company how CPV/OPV can be realized – especially where to start
with CPV/OPV for legacy product.
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About the speakers
Inger Jönebring
Senior GMP Consultant, MedIQ Consulting AB
Inger Jönebring works as a Senior GMP Consultant at MedIQ Consulting AB. Inger has approximately 18
years of good manufacturing practice (GMP) and validation experience within the pharmaceutical and
biotech industry mostly in Sweden. For the last 10 years she has been working as a consultant as GMP &
Validation specialist, Project Manager and QA-approver at several customers of different size. Inger has
worked 14 years at quality control laboratories within the pharmaceutical-, biotech- and food industry
with e.g. qualification of analytical instruments, Process Analytical Technology. Inger has a Master of
Science with a major in Analytical Chemistry (Chemometrics) from the Stockholm University.
Daniel Nilsson
Senior Management Consultant, Aregab AB
Daniel has worked in the Pharmaceutical and Biotech industry for more than 15 years. Currently he is
working as a management consultant in Strategy and Business Transformation in Stockholm, Sweden.
Daniel has recently relocated back to Sweden from Shanghai, China, after a long term assignment as
director of the business area GMP and Validation Services for Pharmadule Morimatsu in Shanghai, China,
where he and his team assisted domestic Chinese companies in reaching compliance with Chinese, WHO,
EU and US GMPs, as well as supporting international organizations in navigating the opportunities and
challenges of the Chinese Life Science market. Over the years Daniel has worked in projects in many parts
of Europe and the United States.
Dr. Lorenz Liesum
Lead Process Analytical Technology (PAT), Novartis Pharma AG
Leading a team within Global Pharma Engineering for :
- Implementation of PAT methods in production
- Supporting QbD submissions
- Usage of MVDA (Multivariate Data Analysis) for on-line monitoring as well as for root cause and trend analysis
- Providing technical engineering support
Timur Güvercinci
Head of Validation, Qualification & Engineering, Merck KGaA
Timur Güvercinci is a pharmaceutical engineering with extensive experience in validation in the pharmaceutical and medical device industry. Timur graduated from Albstadt-Sigmaringen University in Germany with
a graduate engineer of pharmaceutical engineering. As the Head of Validation, Qualification and Engineering
in the Quality Assurance at Merck Biopharma (Darmstadt, Germany) he is responsible for the local validation
requirements by the company. Timur has been working for several years in the pharmaceutical and medical
device industry in various quality positions in different companies, where he had the opportunity to learn the
implementation of validation requirements in different sectors of the industry.
Tara Scherder
Managing Director, Arlenda Inc.
Has over 25 years of experience in the chemical and pharmaceutical industries as a statistician, process
engineer, and master black belt. She has functioned as both an in-house and external statistical consultant to vaccine, API, and pharmaceutical manufacturing teams across the product lifecycle. Her current
focus is the implementation of statistical methods and associated business processes for lifecycle process
validation. She is passionate about teaching others the value and application of statistical methods.
Tara’s formal education includes a BS degree in Chemical Engineering from the University of Pittsburgh
and a MS degree in Statistics from Carnegie Mellon University. She is the Chief Scientific Officer of Supply
for Arlenda, Inc. Arlenda partners with clients in the pharmaceutical industry to leverage information to
accelerate development, improve processes, and assure quality.
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About the speakers
Monica Hueg
NNE Pharmaplan
Monica Hueg is a Global Technology Partner within GMP and compliance at NNE Pharmaplan. She has
more than 15 years of experience with production and construction of biotech, pharmaceutical and
medical device facilities. During her professional career, Monica has built a broad and solid palette of
theoretical expertise and practical experience within GMP and compliance. She has applied her ability
to analyse, plan, implement and complete tasks in a wide range of projects within the pharma industry
globally. For the past five years Monica’s focus has been on providing consultancy services to facilitate
strategic business decisions with special focus on quality and compliance. For instance, she has provided
consulting in high-end strategic planning for future improvements to ensure compliance going forward
often in connection with compliance gap analysis/assessments. Furthermore, Monica regularly teaches
courses within GMP and compliance and has also developed a number of educational courses.
Vibeke Brun Jensen
NNE Pharmaplan
Vibeke Brun Jensen is Director for the Compliance Consulting department at NNE Pharmaplan. She has
more than 19 years of experience in regulated companies and has extensive knowledge of GMP guidelines
and medical device and drug regulations issued by FDA and local European medicines agencies and ISO
standards. Vibeke’s focus is on implementation and assessment of quality management systems and
critical quality process.
Vibeke helps facilitate strategic business decisions with special focus on quality and compliance in both
the pharma and the medical device industry and has taken roles as:
•
project manager in GMP compliance projects
•
GMP consultant, developing and implementing global validation strategies
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Subject matter expect on validation
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responsible for aseptic production
•
in charge of implementing new equipment
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Registration
Registation is done here:
Please register before 23.05.2016 on: https://ispenordic.nemtilmeld.dk/18/
Conference Fee
Category
ISPE Member
Non Member
Industry
€ 175
€ 415*
Academia, Regulatory & YP
€ 110
€ 210*
Students
€ 75
€ 110*
*) Includes one year ISPE membership
Tabletop Exhibition
This conference is an excellent opportunity to meet people working with all kinds of aspects
within Pharmaceutical Production. We can offer a limited number of table top exhibition possibilities for only € 400 (excl. conference fee). Contact us for further information.
Location
ÅF building, Frösundaleden 2, 169 99 Solna.
Approximately 10 minutes’ walk from the commuter train station “Solna Station”.
Questions regarding the event:
Anna Kälvemark, ComplyiT, (ISPE Nordic Affiliate),
E-mail: anna.kalvemark@complyit.se
Phone: +46 733 580 199