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...
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...
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.
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...
Through group exercises, this classroom course on Quality by Design will delve into implementation and operation of an effective and efficient control....
Published: November 2011 Pages: 188 Table of Contents Special Pricing for Emerging Economies Product Realization using QbD: Concepts and Principles (PQLI® Guide Part 1) includes the topics of Criticality, Design Space, and Control Strategy and
Published: November 2011 Pages: 232 Table of Contents Special Pricing for Emerging Economies Product Realization using QbD: Illustrative Example (PQLI® Guide Part 2) presents the small molecule case study developed by the ISPE PQLI® teams. This case
