The Pharma industry is facing extreme change. Gone are the days when pharmaceutical manufacturers made million in profits no matter the times. Today’s challenges are transmuting the field’s reality for the future: expiration of blockbuster drug patents, a decreasing pipeline of blockbuster drugs, pressure from generics, doubt about the future of healthcare compensation, mergers and acquisitions.
This somber panorama is moving Pharmas to evaluate the best ways to combine and manage themselves while urging external organizations to do the same in order to continue being competitive.
To maximize their profits, Pharmas are scanning their activities to achieve optimization, efficiency, and quality amid the crisis. Manufacturing is in this scope, as companies try to lower costs throughout every area, prompting bold manufacturers to expand their Lean Six Sigma enterprises with predictive modeling techniques, to earn new perception, and encourage change within the organization.
For many years, the Pharma industry has been characterized for being delayed in manufacturing efficiency and productivity, specially because it is very expensive and involves a great deal of work to comply with regulatory principles, which call for revalidation of processes after a change. This has established a road of inefficiency, waste, and lack of quality control.
Until now, pharmaceutical manufacturers had not had any economic motivators to support change, and now they face the consequences. Luckily, in recent years, they have received some support from the FDA and other regulatory bodies, which recognize the lack of efficiency and quality control and have backed up a “quality by design” model to substitute the previous one of “quality by test results”.
The FDA has established the Process Analytical Technology (PAT) initiative, which aims at guiding pharmaceutical manufacturers towards consistent, predictable, and higher quality levels. By accepting PAT, Pharmas are changing their focus to two management approaches: Lean manufacturing and Six Sigma, with the intention of reducing waste to meet customer demand and market changes, and to lessen the variation in products and processes, to avoid product defects.
Lean and Six Sigma are powerful tools to improve quality, compliance, productivity, costs, and speed, allowing for the Pharma to provide better products in a cheaper and faster way.
But it doesn’t stop there. To effectively leverage PAT and Six Sigma, pharmaceutical manufacturers must use modeling tools that improve quality even before a product is manufactured. They require predictive analysis that gives them information about the impact of numerous changes, in ingredients or processes, on the quality of the end product. The Monte Carlo simulations is such a tool. It uses probability distributions as process inputs, instead of one value.
In this way, pharmaceutical manufacturers can predict the quality of a product more accurately, thus, balancing the quality demands of Six Sigma against Lean principles, that aims to manufacture products faster and cheaper. It may also help in predicting manufacturing demand and cycle periods, as well as the critical steps to achieve the best quality.
Imagine the improvement over current practices of testing quality once the manufacturing process is over! To get started, research thoroughly the Monte Carlo model and even ask pharmaceutical consulting firms for detailed information on its implementation.
Embracing change today is the way to flourish. New methods like Lean Six Sigma, supported by prediction tools, clear the path towards a better future and a better company, all for the common good.
