GMP Certification Programme

Certified Technical Operations Manager

Speakers

Product Transfer
Organisation of a GMP-compliant Site Change
Dr Reinhard Adam
BIPSO

10-12 October 2023 | Munich, Germany

Stefanie Hermanns
Merck

Dr Eva Keller
Ferring

Christof Langer
OSConsulting

Dr Jean-Denis Mallet
Former Head of the Pharmaceutical In- Highlights
spection Dpt. AFSSAPS ƒ Development of a regulatory transfer strategy
ƒ Handling of process changes during the transfer
ƒ Handling of GMP and Regulatory gaps at the donor site
ƒ Critical Quality Attributes to consider in transfers of sterile and solid
dosage forms
ƒ Organisation of the Analytic Transfer
Dr Lisa Matzen ƒ Project Management
Boehringer Ingelheim - Timelines, key milestones and structure of different transfer projects
- Monitoring of the transfer activities
ƒ GMP-compliant documentation of the transfer
- Transfer SOP, Transfer Master Plan, Proof of Equivalence
ƒ Finalisation of the transfer

Dr Harald Stahl
GEA
Workshop: Development of a Transfer Plan

Receive electronic copies of a Transfer SOP

and a Transfer Master Plan as Download
Programme

Objective Target Audience

Learn how a successful and GMP-compliant process transfer should be This course addresses staff from Production, Engineering, Quality As-
conducted. The key issues are the main topics of this course: develop- surance, Regulatory Affairs and Project Management in charge of Trans-
ment of a regulatory strategy, project management as well as docu- fer Projects. This involves Project Leaders and project team members,
mentation of the transfer activities. from receiving sites as well as from donor sites.

Background Moderator
The changing nature of the business strategies of pharmaceutical com- Christof Langer, OSConsulting
panies necessitates intra- and intercompany transfers of technology to
create additional capacity for a new product, relocations of operations,
site closures, and consolidations and mergers. Transfer of processes to Programme
an alternative site can occur at any stage in the product life-cycle, from
development, scale-up, manufacturing, production and launch, to the Fundamentals of Technology Transfer
post-approval phase.
ƒ Various types of transfer
The expertise from development, manufacturing, analytics, regulatory ƒ Regulation and GMP challenges for Technology Transfer
affairs, supply chain and engineering is necessary at least. This means ƒ Identifying key elements of Technology Transfer
that a transfer cannot be handled by a single person. Therefore it is es- ƒ What to consider when planning a Technology Transfer
sential to build cross-functional transfer teams as a first step in the ƒ How to set acceptance criteria for a successful transfer
transfer project. As interests and expertise are quite different within
the team it is further essential to understand the project in its entirety Product Transfer from a CMO Management Perspective
and the tasks and deliveries of the single sub-teams. This is especially
true for the transfer project leader. ƒ Why to conduct tech transfers to a CMO?
ƒ Facts and Figures
The team is confronted with manifold issues. The process being trans- ƒ Dos and Don’ts - What to consider when working with a CMO?
ferred must be understood and sufficiently described – which can be a ƒ How to apply the “One Face to the Customer”-Concept in
problem, especially for products from development or older products. complex tech transfer situations?
But without this understanding the proof of equivalence after the trans-
fer will never be successful. Regulatory Affairs for Production Transfers
In most of the cases the project is determined by the regulatory strate-
gy. But Regulatory Affairs often finds that the filed process descriptions ƒ Regulatory planning and strategy for production site transfers
and the actual process in the donor site differ from each other. So trans- (development projects and approved products)
fer projects are very often also product maintenance projects. This costs ƒ Complex global regulatory environment (country specific
time and money which both commonly were not budgeted. requirements, approval timelines, change categories and
transition rules ) in the context of production site transfers
The planned approach, the documentation of the transfer activities as ƒ Particulars for NCEs and NBEs in the context of production site
well as written procedures are part of the EU GMP rules, as you can see, transfers
e. g., in chapter 4 of the EU GMP Guide. But also without these demands ƒ Success factors for efficient regulatory management and
from authorities: planning and documentation are the key factors for a execution of production site transfers
successful transfer.
Technological Aspects: Transfer of Oral Solid Dosage
We want to give answers to questions like this: Forms
ƒ What do agencies expect?
ƒ How is the regulatory strategy developed? ƒ Identifying materials involved
ƒ What are the milestones? How can the project be ƒ Defining the process, equipment and facility requirements
structured? ƒ Defining validation requirements
ƒ What are the critical quality attributes in transfers of sterile or ƒ Product hand over and completion of oral dose transfer
oral solid dosage forms?
ƒ How are process changes handled that are occurring during the Sterile Manufacturing Site Change -
transfer? Process Characteristics
ƒ What can a GMP-compliant documentation look like?
ƒ Comparison of equipment and clean rooms / barrier systems of
sending and receiving unit
GMP Transfer Templates ƒ Critical quality parameters of product and process
ƒ How to establish comparability criteria
All participants will receive helpful documents and templates
ƒ What is fixed and what can be changed: packaging material,
via download, e.g. Transfer SOP, Transfer Checklist and Transfer
process parameters, equipment, ... (?)
Master Plan.
ƒ Frequent failures & trouble shooting

Product Transfer | 10-12 October 2023, Munich, Germany

 Speakers

Case Study Ferring: Transfer of an (aseptic Dr Reinhard Adam

lyophilized) US Product between European Sites BIPSO GmbH, Germany
Dr Adam is a pharmacist and has been working for almost
ƒ Scope of the Site Change 20 years for sanofi-aventis (Hoechst) and Berlin Chemie as
ƒ Project Plan, Project Phases and Timelines Head of Production. He has been responsible for the transfers of devel-
ƒ Documentation of the transfer opment products to routine production and for site changes of market-
ƒ Regulatory Strategy (US) ed products. Since 2017 he is general manager of the Bracco site of
ƒ Unforeseen gaps BIPSO in Singen.
ƒ Project Reporting
Stefanie Hermanns
Production Transfers – Case studies including Do’s Merck, Germany
and Don’ts from a Regulatory Perspective Stefanie Hermanns is a pharmacist and works as QA Man-
ager for Merck Healthcare KGaA. Her main focus is on pro-
ƒ Case study: production transfer during development (from cess and product monitoring. She has also been working for Boehringer
development to commercial launch sites) Ingelheim in the position of a Product Quality Manger being responsible
ƒ Case study : production transfer for an approved product for CMOs with regards to QA/QC/Regulatory Affairs, Project Manage-
ƒ Typical health authority questions including do’s & don’t from a ment and Product-Transfers.
regulatory perspective
Dr Eva Keller
Analytic Transfer – Organisation & Scheduling Ferring GmbH, Germany
Eva Keller is Senior Manager at Ferring GmbH in Kiel,
ƒ Pre-requisites when considering an analytical method transfer where she is responsible for validation and product trans-
ƒ Dealing with non-validated methods fer to and from the Kiel site.
ƒ Why analytical methods should be transferred first?
ƒ Is training of “receiving” analysts to be performed at “sending” Christof Langer
site? OSConsulting
ƒ Using ICH Q2 as a support for the transfer of an analytical Christof Langer studied Biotechnology and is certified Risk
method Manager as well as a Lean Six Sigma Black Belt. He has
ƒ Comparison of results: what are acceptable criteria ? been working as Managing Director at Baxter BioScience, responsible
for Operations. Since 2009 he runs his own consultancy business.
Project Management
Dr Jean-Denis Mallet
ƒ Setting up the project and the Transfer team ECA; former head of the French Inspection
ƒ Project Plan and Transfer Mater Plan: how to document the Department AFSSAPS; NNE Pharmaplan,
transfer activities France
ƒ Monitoring of the transfer activities Jean-Denis Mallet was the Head of the Pharmaceutical and Cosmetics
ƒ Definition of milestones and time management Inspection Department at the French Health Products Regulatory Agen-
ƒ Pre-evaluation and feasibility phase, preparatory phase, project cy (Afssaps). He also used to work in or with the pharmaceutical indus-
completion phase try during many years at various positions including Quality Assurance,
Production Management, Engineering and GMP Consulting. Now he is
GMP-compliant Documentation & Finalisation member of the ECA advisory board and works for NNE Pharmaplan.

ƒ Defining documentation required pre & post transfer Dr Lisa Matzen

ƒ Roles and responsibilities of parties in preparation, review and Boehringer Ingelheim, Germany
approval of documentation Lisa has held several positions within Boehringer including
ƒ Reporting of transfer findings and change control CMA RA Manager, Office Head CMC RA and Head of Cardio-
ƒ How to manage the transition period (e. g. first few batches!) vascular Office (Global Regulatory Affairs). Currently she is Head of the
ƒ Document check list Global CMC RA Group, (Global Regulatory Affairs) at Boehringer.

Dr Harald Stahl
GEA, Germany
Workshop Development of a Transfer Dr Harald Stahl worked in the Pharmaceutical Develop-
Plan ment of Schering AG in Germany. Since 1995 he served
within GEA Process Technology in various positions. Presently he owns
In the workshop you will apply what you have learned. You will de- the position of a Group Director Application & Strategy Management of
velop a plan for a transfer project. This will include sourcing of the GEA. He has published more than 20 papers on various aspects of phar-
materials, the validation plan, training at the new site, and risk as- maceutical production.
sessment and action planning.

Product Transfer | 10-12 October 2023, Munich, Germany

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