Quality by Design (QbD)

Good data are a characteristic of good science. Quality data are arguably more important today than ever before and are considered by many to be a corporate asset because they are used to develop products and processes, control our manufacturing processes, and improve products and processes when needed.1

• 1Snee, R. D. “Crucial Considerations in Monitoring Process Performance and...

As the global population demands faster and more affordable drugs, biopharmaceutical companies are continually trying to find ways to produce their drug products more economically and efficiently. Today, the competition and need for drugs are greater than ever before. Companies have been considering operational alternatives to reduce production costs and increase manufacturing rates.1

• 1

In recent years, the concept of quality in the pharmaceutical industry has evolved from the idea of testing the quality to designing the quality. The fundamental idea is very simple; it is necessary to understand the material and process variables that determine the final product’s quality from the beginning of product development. Such an approach permits an in-depth understanding of the...

Although it includes some background material, this article is based predominantly on a series of interviews with SMEs at Eli Lilly, Janssen, Hovione, C-SOPS, and Patheon from October to December 2017. The comments and observations that follow are theirs.