Quality by Design (QbD)

Technical
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...
Technical
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...
Technical
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.
Training
If you are involved in a PAT project, or are simply interested in learning more about PAT, this two-part webinar series provides you with an understanding of the fundamental aspects. This first webinar summarizes reasons...
Training
Through group exercises, this classroom course on Quality by Design will delve into implementation and operation of an effective and efficient control....
Guidance Docs
Published: November 2011 Pages: 188 Table of Contents Special Pricing for Emerging Economies Part 1 includes the topics of Criticality, Design Space, and Control Strategy and addresses product and process development, transfer to, and establishment
Guidance Docs
Published: November 2011 Pages: 232 Table of Contents Special Pricing for Emerging Economies Part 2 presents the small molecule case study developed by the ISPE PQLI® teams. This case study provides details of the application of the approaches to