Getting to Know Flow Charting in Lean Biomanufacturing

Lean Biomanufacturing, Dr. Nigel J. Smart

When it comes to lean biomanufacturing, flow charting is deemed as one of the most basic techniques for defining what is required to operate a particular process. It is no question that the biopharmaceutical industry has evolved quite tremendously in recent years, and as we adapt to these changes, it’s vital to understand the progression in which the industry is transforming. The pharma industry is developing in a very systematic manner, involving products and processes that were initially defined by R&D-based bench scientists.

The cost constraints involved when developing pharmaceutical and biopharmaceutical products are significant, which is why final methods, ideals for development and production are not established until there is some sort of understanding, or rather proof, that the material in question will be an effective medical product.

Here is a list of the basic operating principles defined in developing the flow of process:

  • Process starting point
  • Tasks/Actions
  • Decision points (Yes or No)
  • Tasks/Actions after the established decision has been made
  • Process End Point

A concise way of developing and analyzing potential medical products, the flow charting method is an effective way to ensure that the active materials in question are in line with the medical guidelines set forth by the industry. It is no question that flow charting can alleviate much of the time and cost that is potentially at stake when developing pharmaceutical/biopharmaceutical products.

For further information on flow charting and the overall pharmaceutical development process, please refer to the publication, Lean Biomanufacturing, by Nigel J. Smart.