GMP Certification Programme
Certified Technical Operations Manager
Speakers
Product Transfer
Organisation of a GMP-compliant Site Change
Dr Reinhard Adam
BIPSO
20-22 October 2020 | Berlin, Germany
Stefanie Hermans
Merck
Dr Afshin Hosseiny
ECA & Former Director QA at GSK
Dr Hiltrud Horn
Horn Pharmaceutical Consulting
Dr Eva Keller
Ferring Highlights
Development of a regulatory transfer strategy
andling of process changes during the transfer
H
Handling of GMP and Regulatory gaps at the donor site
Critical Quality Attributes to consider in transfers of sterile and solid
dosage forms
Dr Jean-Denis Mallet Organisation of the Analytic Transfer
Former Head of the Pharmaceutical Project Management
Inspection Dpt. AFSSAPS -- Timelines, key milestones and structure of different transfer projects
-- Monitoring of the transfer activities
GMP-compliant documentation of the transfer
-- Transfer SOP, Transfer Master Plan, Proof of Equivalence
Finalisation of the transfer
Including:
- Workshop: Development of a Transfer Plan
- Electronic copies of a Transfer SOP and a
Transfer Master Plan on USB-Stick
Programme
Objective Target Audience
Learn how a successful and GMP-compliant process transfer This course addresses to staff from Production, Engineering,
should be conducted. Quality Assurance, Regulatory Affairs and Project Management
The key issues are the main topics of this course: development of in charge of Transfer Projects. This involves Project Leaders and
a regulatory strategy, project management as well as documen- project team members, from receiving sites as well as from do-
tation of the transfer activities. nor sites.
Background Programme
The changing nature of the business strategies of pharmaceuti- Fundamentals of Technology Transfer
cal companies necessitates intra- and intercompany transfers of
technology to create additional capacity for a new product, relo- Various types of transfer
cations of operations, site closures, and consolidations and egulation and GMP challenges for Technology Transfer
R
mergers. Transfer of processes to an alternative site can occur at Identifying key elements of Technology Transfer
any stage in the product life-cycle, from development, scale-up, What to consider when planning a Technology Transfer
manufacturing, production and launch, to the post-approval How to set acceptance criteria for a successful transfer
phase.
Transfer to a CMO
The expertise from development, manufacturing, analytics, reg-
ulatory affairs, supply chain and engineering is necessary at W hy to conduct tech transfers to a CMO?
least. This means that a transfer cannot be handled by a single- Facts and Figures
person. Therefore it is essential to build cross-functional trans- Dos and Don’ts - What to consider when working with a
fer teams as a first steps in the transfer project. As interests and CMO?
expertise are quite different within the team it is further essen- How to apply the “One Face to the Customer”-Concept in
tial to understand the project in its entirety and the tasks and complex tech transfer situations?
deliveries of the single sub-teams. This is especially true for the
transfer project leader. Technological Aspects: Non-Sterile Transfers
The team is confronted with manifold issues. The process being Identifying materials involved
transferred must be understood and sufficiently described – efining the process, equipment and facility requirements
D
which can be a problem, especially for products from develop- Defining validation requirements
ment or older products. But without this understanding the Product hand over and completion of oral dose transfer
proof of equivalence after the transfer will never be successful.
In most of the cases the project is determined by the regulatory Sterile Manufacturing Site Change -
strategy. But Regulatory Affairs often finds that the filed process Process Characteristics
descriptions and the actual process in the donor site differ from
each other. So transfer projects are very often also product C omparison of equipment and clean rooms / barrier
maintenance projects. This costs time and money which both systems of sending and receiving unit
commonly were not budgeted. Critical quality parameters of product and process
How to establish comparability criteria
The planned approach, the documentation of the transfer activi- What is fixed and what can be changed: packaging
ties as well as written procedures are part of the EU GMP rules, material, process parameters, equipment, ... (?)
as you can see, e.g., in chapter 4 of the EU GMP guide. But also Frequent failures & trouble shooting
without these demands from authorities: planning and docu-
mentation are the key factors for a successful transfer. Case Study Ferring: Transfer of an (aseptic
lyophilized) US product between European sites
We want to give answers to questions like this:
What do agencies expect? Scope of the Site Change
How is the regulatory strategy developed? roject Plan, Project Phases and Timelines
P
What are the milestones? How can the project be Documentation of the transfer
structured? Regulatory Strategy (US)
What are the critical quality attributes in transfers of Unforeseen gaps
sterile or oral solid dosage form? Project Reporting
How are process changes handled that are occurring
during the transfer?
What can a GMP-compliant documentation look like?
Product Transfer | 20-22 October 2020, Berlin, Germany
Analytic Transfer – Organisation & Scheduling Speakers
P re-requisites when considering an analytical method Dr Reinhard Adam, BIPSO GmbH, Germany
transfer Dr Adam is a pharmacist and has been working for almost 20
Dealing with non-validated methods years for sanofi-aventis (Hoechst) and Berlin Chemie as Head of
Why analytical methods should be transferred first ? Production. He has been responsible for the transfers of devel-
Is training of “receiving” analysts to be performed at opment products to routine production and for site changes of
“sending” site ? marketed products. Since 2017 he is general manager of the
Using ICH Q2 as a support for the transfer of an analytical Bracco site of BIPSO in Singen.
method
Comparison of results : what are acceptable criteria ? Stefanie Hermanns, Merck, Germany
Stefanie Hermanns is a pharmacist and works as QA Manager for
Developing a regulatory strategy for a site change Merck Healthcare KGaA. Her main focus is on process and prod-
uct monitoring. She has also been working for Boehringer Ingel-
Regulatory Guidance documents heim in the position of a Product Quality Manger being responsi-
ifferences EU, US, RoW
D ble for CMOs with regards to QA/QC/Regulatory Affairs, Project
Classification of transfers from a regulatory point of view Management and Product-Transfers.
Data & documents needed
Timelines & costs Dr Hiltrud Horn, Horn Pharmaceutical Consulting,
Germany
Handling changes during a process transfer Dr Hiltrud Horn is managing director of HORN PHARMACEUTI-
CAL CONSULTING with focus on CMC, GMP and Regulatory Af-
After having set up a regulatory strategy for a site change, most fairs. She started in pharma industry in 1990 and held several
often further process and technology changes occur and become managerial positions within Hoffmann-La Roche in Basel and
necessary for continuing with the transfer project. Knoll (Abbott) with global responsibility within QC / QA / Regu-
How to deal with this unplanned changes? latory Affairs / Project Management / Medical Writing.
Classification of changes
How do this changes alter the overall strategy? Dr Afshin Hosseiny, Tabriz Consulting Limited, UK
Dr Afshin Hosseiny is Managing Director of Tabriz Consulting
Project Management Ltd. Before working as a consultant, he was Director of Quality
Assurance for the Global Supply Network of GlaxoSmithKline.
S etting up the project and the Transfer team He was involved with transfer of 23000 products after the GSK
Project Plan and Transfer Mater Plan: how to document merger, and wrote the GSK guidance document on technology
the transfer activities transfer.
Monitoring of the transfer activities
Definition of milestones and time management Dr Eva Keller, Ferring GmbH, Germany
Pre-evaluation and feasibility phase, preparatory phase, Eva Keller is Senior Manager at Ferring GmbH in Kiel, where she
project completion phase is responsible for validation and product transfer to and from the
Kiel site.
GMP-compliant Documentation & Finalisation
Dr Jean-Denis Mallet, ECA; former head of the French
D efining documentation required pre & post transfer Inspection Department AFSSAPS; NNE Pharmaplan,
Roles and responsibilities of parties in preparation, review France
and approval of documentation Jean-Denis Mallet was the Head of the Pharmaceutical and Cos-
Reporting of transfer findings and change control metics Inspection Department at the French Health Products
How to manage the transition period (e.g. first few Regulatory Agency (Afssaps). He also used to work in or with the
batches!) pharmaceutical industry during many years at various positions
Document check list including Quality Assurance, Production Management, Engi-
neering and GMP Consulting. Now he is member of the ECA advi-
sory board and works for NNE Pharmaplan.
Workshop:
Development of a Transfer Plan
Participants’ comments:
In the workshop you will apply what you have learned. You “It was a very helpful training overall. Brought great
can choose between a sterile or a non-sterile product and discussion. This was a helpful exercise.”
develop a Transfer Plan according to the information and Sonya Meheux, Cytonet LLC
requirements you will get. This will include sourcing of the “Good Seminar with excellent organization and venue”
materials, the validation plan, training at the new site, and Konstantinos Skopelitis, Pharmathen SA, Greece
risk assessment and action planning.
Product Transfer | 20-22 October 2020, Berlin, Germany
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Product Transfer, 20-22 October 2020, Berlin, Germany
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Transfer of a sterile process
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Transfer of a non-sterile dosage form
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