Module 9 2024

03/09/2024

Introduction to Quality by Design

What is Quality by Design (QbD)? • A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management (ICH Q8) The main concepts are: • Begins with the end goal in mind • Builds quality into the system • Uses risk assessments to allow risk based approaches • Takes a systematic approach to development • Implements ongoing monitoring and continuous improvement

Source:April 3, 2020 02:17 PM How to AchieveQuality by Design (QbD) in a new Pharmaceutical Fill Line: Intro and Regulatory (Series Part 1 of 6) Written by PMS

The Organisation for Professionals in Regulatory Affairs

7

Introduction to Quality by Design

Differing Approaches to Pharmaceutical Development Development can be based on minimal approaches or be enhanced by QbD approaches

Knowledge space

Process characterisation / Design space

Proven acceptable range (PAR)

Normal operating range (NOR)

Set point

Source: ICH Q8(R2) Pharmaceutical Development Appendix 1

The Organisation for Professionals in Regulatory Affairs

8

4