Structure of Q8 Part 1 Core document Baseline expectations Optional information Regulatory Flexibility Q8 was envisaged as a 2 part guideline Step 2: Nov 2004 Part 2 Annexes relating to specific dosage forms Appropriate examples of risk management Using Q9 toolbox ICH partners discussing revision of Q6a vs. Part II of Q8

Implementation of ICH Q8 and QbD – An FDA Perspective Chi-wan Chen, Ph.D. Office of New Drug Quality Assessment Center for Drug Evaluation and Research Food and Drug Administration ISPE, Yokohama, Japan June 9, 2006 2 Outline ICH Q8 FDA’s implementation of Q8 FDA’s view on quality by design (QbD) QbD system for pharmaceutical development

Jul. 2003 ICH GMP Workshop Sep. 2003 ICH Q8 ‘Pharmaceutical Development’ EWG established Nov. 2003 ICH Q9 ‘Risk Management’ EWG established Jun. 2004 ICH Q10 ‘Quality Management’ agreed “in principle” Sep. 2004 FDA announcements on implementation Nov. 2004 ICH EWG meetings

ICH Q8(R2) is encouraged (Ref. Q8(R2) Appendix 1). 2 Oct. 2009 What is an appropriate approach for process validation using ICH Q8, Q9 and Q10? The objectives of process validation are unchanged when using ICH Q8, Q9 and Q10. The main objective of process validation remains that a process design yields a product meeting its pre-

ICH Q8 recognises that “Strategies for product development vary from company to company and from product to product. The approach to, and extent of, development can also vary and should be outlined in the submission.” These concepts apply equally to the development of the drug substance manufacturing process. An applicant can choose

methodology presented in ICH Q8, Q9, Q10 and Q11. It is supposed to be into CTD Module 2.3 (Quality Overall Summary). In addition, in order to help readers’ better understanding, some additional contents corresponding to 2.3.P.3”Manufacture” and 2.3.P.5”Control of Drug Product” are also included in this mock.

本研究は、ich ガイドラインのq8「製剤開発に関するガイドライン」（薬食審査発第 0901001 号、平成18 年9 月1 日）の施行に伴い、q8 に対応した医薬品の承認申請のあり方 について検討することを目的とする。q8 ガイドラインは、製剤設計の取り組み方を2 種類

the ICH Steering Committee to further the concept of Quality by Design (Q8, Q9, Q10) for all products (Biotech & NCE) • Yokohama 2007 – ICH SC approves development of a concept paper on Drug Substance along the general themes of ICH Q8, to capture best practices for CTD/S2

ICH Quality IWG: Points to Consider for ICH Q8/Q9/Q10 Implementation Dated: 6 December 2011 As part of risk assessment, risk analysis, as defined by ICH Q9 is: ‘

This mock is prepared to show one approach based on the principles of ICH Q8, Q9 and Q10 guidelines. In order for readers to realize the principles into practices, thought processes of the development are described in detail. Because this mock is to present a scientifically sound case study of enhanced approach