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.

2006年1月5日 · This document describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format.

质量源于设计（Quality by Design ,QbD）： 是一套系统的、基于充分的科学知识和质量风险管理的研发方法，从预先确定的目标出发，强调对产品和工艺的理解以及工艺控制。

2020年4月14日 · This guidance is a revision of the ICH guidance Q8 Pharmaceutical Development (Q8 parent guidance) that published in May 2006. In June 2009, the Q8 parent guidance was revised to add an...

2019年8月7日 · 目前， QbD 理念已广泛应用于药品研发、生产、流通和临床应用。 ICH Q8 指南中明确指出 QbD 理念同样可用于分析方法开发、评估、转移以及验证等方面 [5]，因而，分析方法质量源于设计 （analytical quality by design ，AQbD）[5-22 ]应运而生。

The European Medicines Agency's scientific guidelines on Quality by Design help medicine developers prepare marketing authorisation applications for human medicines. For a complete list of scientific guidelines currently open for consultation, see Public consultations.

This document provides guidance on the implementation of ICH guidelines Q8, Q9 and Q10. It answers the questions about the current procedure of the ICH Quality Implementation Working Group on those guidelines.

对于QbD方法下的控制策略，可以允许通过实时放行检测方法保证终产品达到质量标准要求 [见ICH Q8（R2）附录1]。 一旦进行终产品检验，必须符合质量标准的要求。

2023年11月20日 · The ICH Q8 guideline holds significant importance in the pharmaceutical industry for several reasons: QbD Implementation: At the core of this guideline is the concept of QbD, which shifts the focus from traditional quality testing to a proactive approach that emphasizes designing quality into the product.

QbD Definition (ICH Q8(R)) 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