Dr Reinhard Adam, BIPSO
Stefanie Hermanns, Merck
Dr Eva Keller, Ferring
Christof Langer, OSConsulting
Dr Jean-Denis Mallet, Former Head of the Pharmaceutical Inspection Dpt. AFSSAPS
Dr Lisa Matzen, Boehringer Ingelheim
Dr Harald Stahl, GEA
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.
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?
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.
Fundamentals of Technology Transfer
- Various types of Transfer
- 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
Product Transfer from a CMO Management Perspective
- 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?
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 ?
- 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.