Product Transfer - Organisation of a GMP-compliant Site Change
Berlin, Germany
Course No 17180
Costs
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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org
Speakers
Dr Reinhard Adam, BIPSO
Stefanie Hermans, Merck
Dr Afshin Hosseiny, ECA & Former Director QA at GSK
Dr Hiltrud Horn, Horn Pharmaceutical Consulting
Dr Eva Keller, Ferring
Dr Jean-Denis Mallet, Former Head of the Pharmaceutical Inspection Dpt. AFSSAPS
Stefanie Hermans, Merck
Dr Afshin Hosseiny, ECA & Former Director QA at GSK
Dr Hiltrud Horn, Horn Pharmaceutical Consulting
Dr Eva Keller, Ferring
Dr Jean-Denis Mallet, Former Head of the Pharmaceutical Inspection Dpt. AFSSAPS
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.
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 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:
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 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.
Programme
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
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?
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
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
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 ?
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
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?
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 can choose between a sterile or a non-sterile product and develop a Transfer Plan according to the information and requirements you will get. This will include sourcing of the materials, the validation plan, training at the new site, and risk assessment and action planning.
GMP Conferences by Topics
- Quality Assurance
- GMP in Biotechnology
- Microbiology
- Regulatory Affairs
- GMP in Pharmaceutical Development
- Quality Control
- GDP
- Sterile / Aseptic Manufacturing
- Computer Validation
- Validation
- Technical Operations
- GMP for APIs and Excipients
- Medical Devices
- GMP Basic Training Courses
- Packaging
- Data Integrity