活動報告

QRMにおける形式性の概念とリスク評価におけるGMP管理の扱いについての探求
ケーススタディ：ICP-MSに係る変更管理へのQRMの応用

• 10:00-12:45
  1. Introductory Presentation from Mr. Hiroshi-Fujie-san. (10 mins)
  2. Introduction to the Workshop - KOD to read through Doc 2 (two pages, 15 mins)
  3. Workshop Presentation (27 slides) – this outlines today’s Case Study and the QRM tool that is used in it. (Doc 3, 45 mins)
  4. Break (5 mins)
  5. KOD will present the QRM Exercise in the Case Study. This will involve working through each page of the QRM worksheet and the associated risk matrix table. (Docs 5 & 6, 75 mins)
  6. We will discuss the afternoon Group Work exercises (Doc 4, see below for details).
• 12:45-13:25

  Lunch

• 13:25-15:10

  Group Work – 3 exercises

  各ディスカッションはファシリテータが間に入って翻訳

  Exercise 1A (40 mins)

  The QRM tool used in the risk assessment for the ICP-MS Change Control represents a highly formalised approach to QRM.

  Discuss why a highly formalised approach to QRM was needed for this Change Control. In this regard, think about the following three concepts from ICH Q9(R1):

  1. Uncertainty
  2. Importance
  3. Complexity

  Exercise 1B (40 mins)

  Formality in QRM is an expression of the degree of rigour & effort that is applied to a QRM activity. List any features of the QRM tool/approach that make it highly formalised (i.e. high degree of rigour and effort) and discuss how this aligns with the guidance on Formality in ICH Q9(R1).

  Break (5 mins)

  Exercise 2 (30 mins)

  How does the QRM tool presented in this Case Study today help a company achieve risk-based qualification and validation? What specific features of the tool enable this? Discuss this within your group by referring to Steps 4-8 of the ICP-MS QRM exercise.

• 15:10-15:15

  Break

• 15:15-15:30
  1. One group presents their opinions from Group Work Exercise 1A (5 mins)
  2. Another group presents their opinions from Group Work Exercise 1B (5 mins)
  3. Another group presents their opinions from Group Work Exercise 2 (5 mins)
• 15:30-16:50

  KOD to present his Observations on the Case Study and the QRM Tool (i.e. the worksheet) in terms of QRM Formality and the treatment of GMP controls.

• 16:50-17:00

  Wrap-up & Closing Remarks

リスクベースの適格性評価、バリデーション、及び変更管理をより促進するための、FMEAによるリスク評価に於けるGMP管理の役割

• 10:00-12:40
  1. Workshop Introduction by Mr. Fujie. (10 mins)
  2. Presentation by KOD. (Doc 2, 10 slides, 25 mins)
  3. Reviewing a modified version of FMEA (Doc 3) which shows the classification of GMP controls into S, P and D. (30mins)
  4. Understanding the difference between Severity Controls and Probability / Detection Controls (Doc 4). KOD will read through this. (20 mins)
  5. Break (5 mins)
  6. We will then review a Case Study - Doc 5 (65 mins)
  7. We will discuss the plan for the afternoon and the Group Work - See Doc 6
• 12:40-13:20

  Lunch

• 13:20-14:10

  Group Work Exercise 1

  各ディスカッションはファシリテータが間に入って翻訳

  1. Read through the Case Study in Doc 5 (this is about a deviation at an API site involving an extraction at the wrong pH), and complete it within your group, by filling in the blank sections relating to the classification of the GMP controls as S, P or D.
  2. Document in this document any other GMP controls that are relevant to the failure mode of concern, and classify those controls as S, P or D.
• 14:10-14:15

  Break

• 14:15-15:15

  Completed Case Study from KOD & Group Discussion - See Doc 7

  1. KOD will present his completed version of the Case Study (Doc 7) and we will review his classification of the GMP controls, as S, P or D.
  2. We will also review together the other GMP controls he identified which were relevant to the failure mode of concern, as well as his classification of those controls, as S, P or D.
  3. We will discuss various aspects of the above in the group as a whole.
  4. We will hear from the various groups during this time about how they classified the various GMP controls in the exercise and the other controls they identified.
• 15:15-15:20

  Break

• 15:20-16:50

  Reviewing a completed FMEA exercise - See Doc 8

  KOD will present a completed FMEA exercise (Doc 8) that shows the risk assessment in this Case Study in the format of an FMEA. This FMEA template has the changes that KOD presented during the morning session.

• 16:50-17:00

  Wrap-up & Closing Remarks

  KOD will discuss the intended learnings from today’s workshop, so that we can do effective Risk Assessment and Risk Control activities.

• 10:00-12:30

  Lecture: Explanation of Case Study in preparation for the afternoon Group Work

  1. 25 mins on ICH Q9(R1) Guideline: re Quality Defects, Formality, Subjectivity, Hazard Id and Risk-based Decision-making.
  2. 25 mins on KODʼs 15 slides about Quality Defects & QRM
  3. Break (5 mins)
  4. 55 mins on outlining the Case Study and the 3 Group Work Exercises after lunch (Parts B, C & D)
  5. 40 mins of General Discussion on Part A of the Case Study
• 12:30-13:30

  Lunch

• 13:30-16:25

  Group Work – 3 exercises

  各ディスカッションはファシリテータが間に入って翻訳

  1. Exercise 1 on Regulator Actions: 15 mins Group Work and 15 mins presentation = 30 mins
  2. Exercise 2 on GMP Issues: 30 mins Group Work and 25 mins presentation = 55 mins
  3. Break (10 mins)
  4. Exercise 3 on the Risk Assessment: 40 mins Group Work and 40 mins presentation = 80 mins
• 16:25-16:30

  Break

• 16:30-17:25

  KOD Observations, Presentation

  observationは配布の日本語翻訳を参照

• 17:25-17:30

  Final Comments, Wrap-up

  ファシリテータが間に入って翻訳

• 10:00-12:15

  Lecture: Explanation of Case Study in preparation for the afternoon Group Work

  1. 5 minutes of learning objectives , 65 minutes of lecture, 65 minutes of consecutive interpretation. Using the Case Study, we will learn key QRM concepts.
• 12:15-12:30

  Explanation of how to proceed with the work, and how to summarize the results

  1. Explain how to proceed with Group Work after lunch. For details of the Group Work, please read page 10 of the handout.
• 12:30-13:30

  Lunch

• 13:30-16:10

  Group Work – 4 exercises

  各ディスカッションはファシリテータが間に入って翻訳

  1. Exercise 1: 30 mins Group Work and 20 mins presentation = 50 mins
  2. Exercise 2: 20 mins Group Work and 20 mins presentation = 40 mins
  3. Break (10 mins)
  4. Exercise 3: 30 mins Group Work and 20 mins presentation = 50 mins
  5. Exercise 4: 10 mins Group Work = 10 mins
• 16:10-17:10

  KOD Observations, Presentation

  observationは配布の日本語翻訳を参照

• 17:10-17:20

  Final Comments, Wrap-up

  ファシリテータが間に入って翻訳

• 10:00-10:15

  開会挨拶 講座紹介

  櫻井信豪氏（東京理科大学薬学部医薬品等品質・GMP講座 教授）

• 10:15-11:15

  品質リスクマネジメントの導入解説

  藤江宏氏（元ICHQ9（R1）日本メンバー）

• 11:30-12:30、13:30-16:30 （休憩時間 14:30-14:45、15:45-16:00）

  品質リスクマネジメント（ガイドライン改訂）の概要

  Dr. Kevin O'Donnell（東京理科大学薬学部医薬品等品質・GMP講座 客員教授）

• 16:30-16:40

  QRMアカデミーに期待すること

  中井清人氏（医薬品医療機器総合機構 安全管理監）

• 16:40-16:50

  QRMアカデミーに期待すること

  佐藤大作氏（厚生労働省 大臣官房審議官（医薬担当））

• 16:50-17:00

  閉会挨拶

  中島範行氏（富山県立大学 副学⻑／バイオ医薬品人材育成講座責任者 教授）