OUR APPROACH

Doing contract manufacturing requires careful planning and allocation of resources in order to safeguard excellent performance at all stages of the partnership. At the same time, it requires flexibility throughout the organization so that services can be customized to the needs of each partner. Key features of our approach are our "Best Fit" evaluation, and our project management and risk management programs. We value open and direct communication between your and our staff at every stage of the partnership.This key skills qualify us to be the right partner for producing your sterile pharmaceuticals.

"Best Fit" Evaluation

One of the first steps we apply in designing an offer to our partners is a "Best Fit" evaluation. In this model, client requirements, product characteristics, and manufacturing site competencies are evaluated in combination in order to arrive at a development and/or manufacturing strategy that provides the highest added value for our partner in the short term and long term. This means that we offer concepts that we can commit ourselves to supporting during all stages of the cooperation.

Project Management

For each new project, we appoint a project team, lead by a responsible project leader, who has the job of securing the progress of the project. This project leader is responsible for the internal coordination of the project and for the communication to you as our partner. Furthermore, the contract manufacturing organization of Fresenius Kabi Product Partnering manages the contractual framework for your project and supervises the whole project. The team includes people from all the disciplines relevant to implementing the new processes and products at the manufacturing site. They are able to draw up a fully integrated development and qualification program that includes validations, stability studies, regulatory support and all other elements relevant to a specific product. Of course you, our partner, are closely involved in the creation of this project plan. Again, open and direct communication is of the essence in minimizing time to market.

Risk Management

A vital element of our approach is an assessment of risks and advance planning and evaluation of possible actions to take in contingency situations. We screen the characteristics of the new product and its production processes for their ability to trigger undesired events. As a part of the exercise, special attention is given to environmental issues. The results of our risk assessment are used in designing customized procedures for routine production and for handling deviations. Also, the results of our risk assessment may lead to recommendations about keeping safety stock and/or qualifying multiple production lines or sites.