ICH Q2(R2)／Q14の公式教育マテリアルのリリース

ICHの公式ウェブサイトでQ2(R2)，Q14の公式の教育マテリアルがリリースされていますので紹介します。

これらは7つのモジュールから構成されていて，構成は以下です。現時点では，日本語版はありません。

Module 1：Q2(R2)/Q14

• Step 4 Presentation for ICH Q2(R2) and ICH Q14

Module 2：Q2(R2)

• Fundamental principles of ICH Q2(R2)
  • Part A：Analytical Procedure Validation Strategy
  • Part B：Details of Validation Terms
  • Part C：Combined Accuracy and Precision
  • Part D：Considerations when Setting Performance Criteria

Module 3：Q2(R2)

• Practical Applications of ICH Q2(R2)
  • Part A：ICH Q2(R2) Annex 1 and 2
    • Table 3：Separation techniques
    • Table 5：Dissolution with HPLC
    • Table 8：Quantitative PCR
    • Table 9：Particle size measurement
  • Part B：Other Validation Topics
    • Platform Analytical Procedures
    • Use of Confidence Intervals
    • Use of Replicates
    • Use of Development Data
    • Single Point Calibration
    • Extrapolation of Validation Range
    • Quantitative Test vs. Limit Test

Module 4：Q14

• ICH Q14 General Considerations
  • Part A：Minimal and Enhanced Approach
  • Part B：Analytical Procedure Lifecycle
  • Part C：Analytical Target Profile (ATP)
  • Part D：Risk Assessment in Analytical Procedure Development
  • Part E：Robustness and Parameter Ranges
  • Part F：Analytical Procedure Control Strategy

Module 5：Q14

• Further Concepts in ICH Q14
  • Part A：Established Conditions and the Link to ICH Q12
  • Part B：Change Management – Identification of ECs/Reporting Categories and Decision Tree
  • Part C：Knowledge and Risk-based Change Management
  • Part D：Explanation of ICH Q14 Tables 1 and 2, Implementation of Changes, and Bridging Studies
  • Part E：Submission Requirements in ICH Q14 Chapter 10

Module 6：Q2(R2)/Q14

• Multivariate Analytical Procedure
  • Introduction
  • Examples
    • Raman spectroscopy for identity testing
    • NIR for assay
    • Raman spectroscopy for glucose testing

Module 7：Q2(R2)/Q14

• Additional Case Studies and Examples
  • Impurity Case Study – Measurement of Stereoisomers as Specific Process Related Impurities in a Small Molecule Drug Substance
  • Potency Case Study – Measurement of Potency for an anti-TNF-alpha Monoclonal Antibody
  • MAM Case Study – MAM by Peptide Mapping LC-MS
  • NIR Case Study – At-line Assay of Core Tablets by Multivariate Analytical Procedure in Continuous Manufacturing of a Drug Product
  • Platform Analytical Procedures – Determination of High Molecular Weight Species in Monoclonal Antibody Products
  • MODR Example – Application of the Enhanced Approach Using DoE Studies – Establishment and Validation Options for MODRs

https://www.ich.org/page/quality-guidelines#2-2

（リンクがうまく働かない時は，https://www.ich.org/　より）