PDA Letter Article

Achieve True Manufacturing Reliability

by Hal Baseman, ValSource, and Brett Duersch, Merck and Co.

Industry 4.0

Pharmaceutical manufacturing is changing. Perhaps better stated, the manufacturing of regulated healthcare products must change. We can no longer focus only on manufacturing products that are effective, safe and compliant. Today, we must also manufacture products that are affordable, available and a sound business proposition. This requires more complete knowledge.

The accessibility of information is leading to more complete knowledge. A few key questions reflect on how we can best use this data:

  • 1. Not all data are created equal—some information is more important. What new approaches are required to help prioritize the most important information? How do we build in learning approaches that support priority of data over the lifecycle of a product/process?
  • 2. How can these modern data approaches drive manufacturing improvements that lead to higher product quality and more reliable production?
  • 3. How do we contextualize increasingly complex manufacturing datasets, and easily convert them to knowledge and action? Are there standard approaches that can lead to increased efficiencies within a firm and better sharing of information between companies?
  • 4. What regulatory/quality challenges need to be considered as the quantity and complexity of data explodes? How do we partner with regulators so that everyone can take advantage of the modern data rich environment?
  • 5. What are the barriers/risks of using new systems to gather this information? What are the benefits that make it worth confronting these challenges?

Next month, PDA will hold a groundbreaking workshop on manufacturing intelligence following the 2018 PDA Annual Meeting, bringing together experts and interested parties in an interactive forum to learn about big data and how it can be used to achieve effective manufacturing. This is a very important meeting for those using, or considering using, aspects of big data to operate manufacturing systems. In other words, it is an essential meeting for anyone involved with manufacturing regulated healthcare products.

Learn more about the 2018 PDA Manufacturing Intelligence Workshop.

2018 PDA Annual Meeting