How do I Maximize My Manufacturing Efficiency?

“Scientific understanding, technical knowledge and quality are all ‘perishable’. We must continue to invest in people and in new technologies to ensure we are always up to date”

Innovation
The traditional method for regulatory approval of a manufacturing process of producing three batches that in laboratory testing demonstrate consistent product quality characteristics is being challenged. Since September 2004, the FDA has started to actively encourage the industry to adopt new technologies that secure product quality by design rather than by inspection. Such innovations bring the potential to improve manufacturing efficiency. We support this effort and aim to work in partnership with the regulatory agencies to bring benefits to patients in terms of heightened product quality. The benefits also extend beyond product quality – they improve equipment utilization, supply performance and waste reduction.

A twofold approach
For new products under development, we are building a fundamental scientific understanding of each of the processes used to manufacture the product. With this knowledge, we can establish operating parameters within which we know we will always produce quality product. Having gained this control over our processes we can introduce real-time data gathering and analysis systems and install feedback loops to maintain the process within the set parameters automatically. Alongside this activity we can deploy in-process quality assurance so that parametric release is possible.

For existing products we are carrying out extensive work on process understanding, control and capability. Detailed scientific analysis of both the production process and the subsequent laboratory testing is highlighting areas where we can improve our levels of control and make gains in product quality and productivity. We also have two projects where we are collaborating with the FDA as part of their CMC Pilot Program.

Automation and information technology
Through automation and IT we can generate and analyze significant quantities of data about the manufacturing process – often in real-time. This means that not only can we demonstrate to regulators that our processes are under control at a specific point in time, but we can also provide trend data that shows how the process has been performing over a period of minutes, hours, days or even months.

The same data that is generated to demonstrate product quality can also be used to improve manufacturing efficiency. So the business objectives of pharmaceutical manufacturing are also met in terms of improvements in equipment utilization, supply performance and reduced waste which in turn leads to a reduction in cost of goods.

Lean manufacturing and Six Sigma
We have been using the concepts of lean manufacturing and Six Sigma for more than five years. Amongst other benefits, our use of lean manufacturing techniques has led us to carry out end-to-end reviews of the supply chain for several products. These reviews have led to the elimination of some unnecessary activities and increased efficiencies in others. The overall gain has been a reduction in customer lead time, increased flexibility and responsiveness to meet sales forecasts and a reduction in cost of goods.

The implementation of Six Sigma in the 1990s led us to study the effectiveness of our production processes and to generate savings by eliminating waste. This work has also provided an excellent springboard into the current activity to drive up the capability of our processes and introduce innovative technology to assess and control manufacturing activity.

Addressing challenges
Scientific understanding, technical knowledge and quality are all ‘perishable’. We must continue to invest in people and in new technologies to ensure we are always up to date. One such example is in solid oral dose products. The manufacturing processes are complex and we are developing strong capabilities in solid-to-solid particle physics and in multivariate statistical analysis to manage and control these challenging processes.

Many other processes also require the analysis of multiple variables to identify the critical to product quality parameters that we need to manage to gain control over the process. Such analysis requires complex statistics and accordingly top class statisticians. The same is true for many other scientific disciplines.

Three key routes to increase efficiency in the future
We will influence the development part of the R&D process to ensure that as new products are developed they are designed for manufacture – meaning that the process handed over during scale up of production is fully robust with in-depth scientific understanding of each process step.

By leveraging technological innovation we intend to secure real-time process control over our operations and achieve parametric release. This will also enable us to transition from batch manufacturing processes to continuous processes where this is feasible.

Also aimed at maximizing efficiency is our operational excellence program that educates, engages and provides a toolkit for employees to drive continuous improvement in a rigorous, controlled and structured way.

With 80 sites, which employ around 35,000 people in 37 countries, Pulman has a large manufacturing network to look after. He holds responsibility for the manufacture and supply of all GSK pharmaceutical and consumer healthcare products with the exception of vaccines.