Product Transfer - Organisation of a GMP-compliant Site Change

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 and monitoring 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.
Transfer of technology is a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacturing sites.

At least the expertise from development, manufacturing, analytics, regulatory affairs, supply chain and engineering is necessary. 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 7.4. Since 2010 Chapter 4 of the EU GMP guide has continuously been supplemented with new requirements on the documentation of a transfer and the requirements on written procedures for the execution of a transfer. 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:

• 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?

Participant comment:

"It was a very helpful training overall. Brought great discussion. This was a helpful exercise."
Sonya Meheux, Cytonet LLC