Quality by Design (QbD) - An Introduction

Single web-based interactive training course for self-paced learning.

The learning objective of the course is to gain understanding for the underlying causes of applying the QbD approach in pharmaceutical industry, to become familiar with the basic QbD Elements (Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs)) and learn about their interrelationship.

English

Dr. Barbara Jentges, Phact GmbH

Quality by Design, QbD, is a quality management concept that was developed by the industrial engineer Dr. Joseph M. Juran1. According to Juran quality cannot be tested into a product has to be designed into a product from the very beginning of development.

The application of the QbD concept in pharmaceutical industry was initiated by the U.S. Food and Drug Administration ‘US FDA 21st Century Initiative’ and adopted by the expert working group of the International Council of Harmonization (ICH) in the ICH Guideline Q8 (Pharmaceutical Development).

The concept of Quality by Design (QbD) is defined as a “systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process controls, based on sound scientific and quality risk management” (ICH Q8 (R2)).
Quality of a pharmaceutical product should no longer be based upon extensive testing, tight specifications and a fixed manufacturing process (the ‘traditional’ approach), but should be proactively ‘built into the product’.

The learning contents are structured into four units, whereas each unit can be trained independent of each other:

• Pharma Quality Paradigm Shift
• Traditional Empirical Approach
• Quality by Design Approach
• Product and Process Understanding

At the end of the course the knowledge can be tested in an interactive quiz. During the usage period, the lecture can be interrupted, continued and repeated at will.