So the company turned to NNE Pharmaplan to ensure PAT was implemented successfully, quickly and economically.

With PAT experience, NNE Pharmaplan was the perfect partner to help Novo Nordisk Diabetes Finished Products develop a PAT strategy and implementation plan. NNE Pharmaplan also has a cross-functional structure, ensuring that the project had sufficient expertise in every required area, from change management to strategy development.

A simple and comprehensive process
The project was split into a number of steps to allow systematic implementation. Initially, NNE Pharmaplan helped Novo Nordisk Diabetes Finished Products set up the right project team, including the technical and managerial elements that would ensure success.

The next step was to establish realistic and understandable goals around the PAT concept. An essential part of this was making sure the Diabetes Finished Products PAT strategy was in alignment with other strategies within the Novo Nordisk organisation, such as IT and quality strategies.

With the goals in place, NNE Pharmaplan analysed the current state of the business and manufacturing process, and then mapped out the desired state. This created the groundwork for strategic project planning – which defined the ideal pilot site and the criteria which would be used to judge success. With all this done, everything was in place to implement the plan.

Benefits for every level of Novo Nordisk Diabetes Finished Products
The key to the success of the strategy was ensuring it affected the entirety of Novo Nordisk Diabetes Finished Products. The PAT strategy was not simply for the upper echelons of management; instead it was designed to impact the day-to-day running of Novo Nordisk Diabetes Finished Products.

It took almost four months to develop the organisational PAT strategy – and during this time, the project team communicated the fundamental changes in thinking that PAT required, to the entire organisation within Novo Nordisk Diabetes Finished Products. Part of this involved choosing five real projects that would provide short-term and mid-term technical successes. These projects proved the benefits of PAT, and gave people in Novo Nordisk Diabetes Finished Products real examples to discuss and analyse.

The projects included:

• Increasing process and product understanding in order to improve facility utilisation, product quality and reduce cost of goods sold
• Improving quality through less waste and reduced process variability
• Increasing efficiency by improving processes and finished products, and by reducing scale up and technical transfer problems