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...
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.
Through group exercises, this course on Quality by Design will delve into implementation and operation of an effective and efficient control strategy....
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
