デザインスペース：国内外の動向

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1 デザインスペース (design space, DS) とプロセス解析工学 (Process Analytical Technologies, PAT) 有限会社レギュラトリーサイエンス研究所秦武久平成 21 年 4 月

2 ICH Qトリオの目的 : 安全性と有効性が保障され一定の高い品質を有した医薬品製剤を安定的に提供することが医薬品企業の責務であるしかしながら残念なことに医薬品の開発過程から市販に至る製品のライフサイクルの中で医薬品の製造や品質に関わる問題が多く発生している日欧米の医薬品規制当局は大きな懸念を抱き GMPと調和させながらより高い品質を有した医薬品製剤を安定的に製造提供する新しい枠組み品質システムの構築を図りつつある近代的品質システムの構築 ICH Q8: 製剤開発 ICH Q9: 品質リスクマネジメント ICH Q10 : 品質システムこのICH Qトリオ (Q8, Q9 及びQ10) における重要なコンセプトとしてクオリティバイデザイン (Quality by Design) やデザインスペース (Design Space) がある GMP(CGMP) 承認された品質規格の製品を恒常的に製造管理することにより安全性と有効性を保証する That part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use GQP:Good Quality Practice 医薬品の品質保証における基準

3 ICHQ8, Q9 及び Q10 による品質システムの構築品質システム Q10 品質リスクマネジメント Q9 製剤開発 Q8 現行 GMP Ref. Dr. Evdokia Korakianity, Quality Sector, EMEA

4 クオリティバイデザイン (Quality by Design) 事前の目標設定に始まり製品及び工程の理解並びに工程管理に重点をおいた確立された科学及び品質リスクマネジメントに基づく体系的な開発アプローチ Eric P. Duffy, PhD Director, Division of Post-Market Evaluation, ONDQA, RSI CDER, Regulatory FDAScience Institute. Inc.

5 デザインスペース : 品質を確保することが立証されている入力変数 ( 原料の性質など ) と工程パラメータの多元的な組み合わせと相互作用デザインスペース内で運用することは変更とはみなされないデザインスペース外への移動は変更とみなされる通常は承認事項一部変更のための規制手続きが開始されることになるデザインスペースは申請者が提案し規制当局が評価し承認する

6 欧州医薬品庁 (EMEA) のプロセス解析工学 (PAT) への取り組み PATチームを2004 年に設立する : PATの定義 : Process Analytical Technologies (PAT):a system for designing and controlling manufacturing through timely measurements (i.e. during processing) of critical quality and performance attributes for raw and in-process materials and also processes with the goal of ensuring final product quality". The PAT initiative focuses on building quality into the product and manufacturing processes, as well as continuous process improvement.

7 PAT: Question 1: PATを適用すると規制当局の承認なしで変更は可能か? When PAT is implemented will the manufacturer be allowed to make changes to the process without need for regulatory "approval"? Answer 1 It is anticipated that the introduction of PAT-based systems will change the way knowledge is presented in the dossier demonstrating greater understanding of the variables that affect product quality attributes, as well as the methods to monitor and control them. One of the expected outcomes is that a "Design Space" within the boundaries of the knowledge described in the development part of the dossier will be established and the process control strategy will fall within this space. We envisage that manufacturers will be able to introduce adjustments without the need for a variation submission provided the manufacturer operates within the "Design Space" defined in the original submission or subsequent variation.

8 Apply for Design Space or Process Analytical Technology (PAT) in my application Questions & Answers 43. Can I apply for Design Space or Process Analytical Technology (PAT) in my application? 申請時にデザインスペースあるいはPATを申請できるか? The ICH Q8 (Pharmaceutical Development) introduces the notion of Design Space, defined as the multidimensional combination and interaction of input variables (e.g. material attributes) and process parameters that have been demonstrated to provide assurance of quality. The Design Space is proposed by the applicant as part of the MAA and thus is subject to assessment. Additionally the establishment of a robust Design Space is in line with new approaches on quality which focus on building quality into the medicinal product by design (the so-called QbD concept) PAT is defined as a system for analysing and controlling manufacturing through timely measurements (i.e. during processing) of critical quality and performance attributes of raw and inprocess materials and processes with the goal of ensuring final product quality. PAT is a tool that allows enhanced control of the manufacturing process, can improve process understanding and so facilitates building quality into products and the development of a Design Space. ICH Q9 (Quality Risk Management) provides an approach and a selection of tools which can be used to manage risks associated with these processes. (Ref.

9 Apply for Design Space or Process Analytical Technology (PAT) in my application The main PAT tools are: PATの手段は Multivariate data acquisition and analysis; Modern process analysers or process analytical chemistry tools; The introduction of the PAT system can bring a number of advantages: Possibilities to introduce real time release ; Reduction of cycle times; Improved product quality; Possibilities for more efficient and effective control of some changes; The introduction of PAT system can be applied to new or existing authorised medicinal products. When to inform the EMEA of the introduction of PAT or Design Space approaches in my application - Where Design Space concepts or PAT approaches are used, Marketing Authorisation applicants should indicate this in their letter of intent. It is of interest for the Agency and CHMP to be aware of their use so it can be taken into account in the appointment of (Co)-Rapporteurship, as particular expertise from (Co)-Rapporteurs may be needed. - In addition, when requesting a pre-submission meeting, the applicant should identify it in the relevant question of the pre-submission request form.

10 デザインスペース及び PAT のベネフィット - リスクベネフィット科学とリスクに基づいて製剤設計製造を評価できる規制当局の審査を受けずに変更でき設計製造に柔軟性が高まるリスク個々の企業が独立にデザインスペースを構築評価する多大な資源が必要である時間がかかる承認後の提出書類を低減できる製品出荷試験を少なくあるいはなくすことが出来る可能性がある工程の十分な理解が重要であることがわかる

11 製剤分野での遠赤外スペクトルの応用 DRAFT GUIDELINE ON THE USE OF NEAR INFRARED SPECTROSCOPY BY THE PHARMACEUTICAL INDUSTRY AND THE DATA REQUIREMENTS FOR NEW SUBMISSIONS AND VARIATIONS London, 16 February 2009 EMEA

システム開発プロセスへのデザイン技術適用の取組み～HCDからUXデザインへ～

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