Former Head of the Pharmaceutical Inspection Dpt. AFSSAPS
Dr Afshin Hosseiny
ECA
Dr Eva Keller
Ferring
Dr Reinahard Adam
BIPSO
Stefanie Hermanns
Merck
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 singleperson. Therefore it is essential to build cross-functional Transfer teams as a first steps 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 form?
How are process changes handled that are occurring during the transfer?
What can a GMP-compliant documentation look like?
Target Group
This course addresses to 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.
Technical Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and e-mail address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
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
Developing a regulatory strategy for a site change
Regulatory Guidance documents
Differences EU, US, RoW
Classification of transfers from a regulatory point of view
Data & documents needed
Timelines & costs
Transfer to a CMO
Why to conduct tech transfers to a CMO?
Facts and Figures
Dos and Don’ts - What to consider when working with a CMO?
How to apply the “One Face to the Customer”-Concept in complex tech transfer situations?
Handling changes during a process transfer After having set up a regulatory strategy for a site change, most often further process and technology changes occur and become necessary for continuing with the transfer project.
How to deal with this unplanned changes?
Classification of changes
How do this changes alter the overall strategy?
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
Technological Aspects: Non-Sterile Transfers
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
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
This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager" Learn more
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Seminar Programme as PDF