Former Head of the Pharmaceutical Inspection Dpt. AFSSAPS
Dr Eva Keller
Ferring
Christof Langer
OSConsulting
Dr. Lisa Matzen
Boehringer Ingelheim
Dr Harald Stahl
Romaco
Objectives
Learn how a successful and GMP-compliant process transfer should be conducted. The key issues are the main topics of this course: development of a regulatory strategy, project management as well as documentation of the transfer activities.
Background
The changing nature of the business strategies of pharmaceutical companies 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 an alternative site can occur at any stage in the product life-cycle, from development, scale-up, manufacturing, production and launch, to the post-approval phase.
The expertise from development, manufacturing, analytics, regulatory affairs, supply chain and engineering is necessary at least. This means that a transfer cannot be handled by a single person. Therefore it is essential to build cross-functional transfer teams as a first step in the transfer project. As interests and expertise are quite different within the team it is further essential to understand the project in its entirety and the tasks and deliveries of the single sub-teams. This is especially true for the transfer project leader.
The team is confronted with manifold issues. The process being transferred must be understood and sufficiently described – which can be a problem, especially for products from development or older products. But without this understanding the proof of equivalence after the transfer will never be successful.
In most of the cases the project is determined by the regulatory strategy. But Regulatory Affairs often finds that the filed process descriptions and the actual process in the donor site differ from each other. So transfer projects are very often also product maintenance projects. This costs time and money which both commonly were not budgeted.
The planned approach, the documentation of the transfer activities as well as written procedures are part of the EU GMP rules, as you can see, e. g., in chapter 4 of the EU GMP Guide. But also without these demands from authorities: planning and documentation are the key factors for a successful transfer.
We want to give answers to questions like this:
What do agencies expect?
How is the regulatory strategy developed?
What are the milestones? How can the project be structured?
What are the critical quality attributes in transfers of sterile or oral solid dosage forms?
How are process changes handled that are occurring during the transfer?
What can a GMP-compliant documentation look like?
Target Group
This course addresses staff from Production, Engineering, Quality Assurance, Regulatory Affairs and Project Management in charge of Transfer Projects. This involves Project Leaders and project team members, from receiving sites as well as from donor sites.
Date & Venue
Date
Tuesday, 16 September 2025, 09.00 to approx. 17.30 h (Registration and coffee 08.30 – 09.00 h Wednesday, 17 September 2025, 09.00 to approx. 17.00 h Thursday, 18 September 2025, 08.30 to approx. 15.30 h
Venue
Barceló Sants Hotel Plaça dels Països Catalans, s/n 08014 Barcelona
Regulation and GMP challenges for Technology Transfer
Identifying key elements of Technology Transfer
What to consider when planning a Technology Transfer
How to set acceptance criteria for a successful Transfer
Regulatory Affairs for Production Transfers
Regulatory planning and strategy for production site Transfers (development projects and approved products)
Complex global regulatory environment (country specific requirements, approval timelines, change categories and transition rules ) in the context of production site Transfers
Particulars for NCEs and NBEs in the context of production site Transfers
Success factors for efficient regulatory management and execution of production site transfers
Technological Aspects: Transfer of Oral Solid Dosage Forms
Identifying materials involved
Defining the process, equipment and facility requirements
Defining validation requirements
Product hand over and completion of oral dose transfer
Sterile Manufacturing Site Change - Process Characteristics
Comparison of equipment and clean rooms / barrier systems of sending and receiving unit
Critical quality parameters of product and process
How to establish comparability criteria
What is fixed and what can be changed: packaging material, process parameters, equipment, ... (?)
Frequent failures & trouble shooting
Case Study Ferring: Transfer of an (aseptic lyophilized) US product between European sites
Scope of the Site Change
Project Plan, Project Phases and Timelines
Documentation of the Transfer
Regulatory Strategy (US)
Unforeseen gaps
Project Reporting
Production Transfers – Case studies including do’s and don’t from a regulatory perspective
Case study: production transfer during development (from development to commercial launch sites)
Case study : production transfer for an approved product
Typical health authority questions including do’s & don’t from a regulatory perspective
Analytic Transfer – Organisation & Scheduling
Pre-requisites when considering an analytical method Transfer
Dealing with non-validated Methods
Why analytical methods should be transferred first?
Is training of “receiving” analysts to be performed at “sending” site?
Using ICH Q2 as a support for the transfer of an analytical method
Comparison of results: what are acceptable criteria ?
Project Management
Setting up the project and the Transfer Team
Project Plan and Transfer Mater Plan: how to document the transfer activities
Monitoring of the transfer activities
Definition of milestones and time Management
Pre-evaluation and feasibility phase, preparatory phase, Project completion phase
GMP-compliant Documentation & Finalisation
Defining documentation required pre & post Transfer
Roles and responsibilities of parties in preparation, review and approval of documentation
Reporting of transfer findings and change Control
How to manage the transition period (e. g. first few batches!)
Document check list
Workshop Development of a Transfer Plan
In the workshop you will apply what you have learned. You will develop a plan for a transfer project. This will include sourcing of the materials, the validation plan, training at the new site, and risk assessment and action planning.
This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager" Learn more
Testimonials
Seminar Programme as PDF