Dr Jean-Denis Mallet
Former Head of the Pharmaceutical Inspection Dpt. AFSSAPS
Referent:innen
Dr Reinahard Adam
ehemals BIPSO
Christof Langer
OSConsulting
Dr. Lisa Matzen
Boehringer Ingelheim
Dr Harald Stahl
GEA
Zielsetzung
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 key issues are the main topics of this course: development of a regulatory strategy, project management as well as documentation of the transfer activities.
Hintergrund
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:
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 form?
- How are process changes handled that are occurring during the transfer?
- What can a GMP-compliant documentation look like?
Zielgruppe
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
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
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
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
- Basic Requirements
- Identification of critical quality Attributes
- Risk assessment and risk Mitigation
- Scale up strategies for granulation and tableting
- How to deal with different types of equipment?
- Examples
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
Production Transfers - Case studies including do’s and don’ts 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
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
Project Management
- Setting up the project and the Transfer Team
- Project Plan and Transfer Master 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
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This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager"
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