ISPE NORDIC CONFERENCE

STOCKHOLM, SWEDEN

26 th MAY 2016ÅF BUILDING, FRÖSUNDALEDEN 2, 169 99 SOLNA.

EU GMP Annex 15

Qualification & Validation and Continuous Process Verification

Prepare yourself for tomorrow’s pharmaceutical production

The ISPE PQLI® Guide: Part 4

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 otherswho 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 toobjectively learn more about a new mandatory regulation we all must adapt to.

This PQLI Guide is relevant for:• New and existing products• Small and large molecule• All phases of product lifecycle, from development through product discontinuation

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

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08:45-09:45

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10:45-11:00

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Conference program 26 May 2016

Registration and Coffee

Welcome and introduction

General update and requirements of Annex 15 and CPVInger Jönebring, Senior GMP Consultant, MedIQ Consulting AB

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

Network break

The Real Challenge of Annex 15 – Continuous Process Verification: Case StudyDr. Lorenz Liesum, Lead Process Analytical Technology (PAT), Novartis Pharma AG

Lunch

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

Designing a Risk Based, Efficient Approach to Ongoing/Continued Process Verification Tara Scherder, Managing Director, Arlenda Inc.

Network break

Implementing CVP in smaller organisations Monica Hueg/ Vibeke Brun Jensen, NNE Pharmaplan

Short Wrap Up

Networking – refreshments and snacks

About the presentations

General update and requirements of Annex 15 and CPVInger 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-the-art 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 verificationTimur 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 VerificationTara 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

Dr. Lorenz LiesumLead 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

Inger JönebringSenior 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.

Timur GüvercinciHead of Validation, Qualification & Engineering, Merck KGaA

Timur Güvercinci is a pharmaceutical engineering with extensive experience in validation in the pharmaceu-tical 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.

Daniel NilssonSenior 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.

Tara ScherderManaging 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 consul-tant 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 HuegNNE 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 JensenNNE 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 • Subject matter expect on validation • responsible for aseptic production • in charge of implementing new equipment

Registration

Tabletop Exhibition

Registation is done here: Please register before 23.05.2016 on: https://ispenordic.nemtilmeld.dk/18/

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 possi-bilities for only € 400 (excl. conference fee). Contact us for further information.

Conference Fee

Category ISPE Member Non Member

Industry € 175 € 415*

Academia, Regulatory & YP € 110 € 210*

Students € 75 € 110*

Questions regarding the event:

Anna Kälvemark, ComplyiT, (ISPE Nordic Affiliate), E-mail: anna.kalvemark@complyit.se Phone: +46 733 580 199

Location

ÅF building, Frösundaleden 2, 169 99 Solna.Approximately 10 minutes’ walk from the commuter train station “Solna Station”.

*) Includes one year ISPE membership