ICH Q2(R2)/Q14の論点とバイオ医薬品に分析法QbDを適用した場合のATP設定及びリスクマネジメントの事例

抄録

Analytical procedures used in the release testing of drug substances and drug products along with manufacturing process controls are important elements of quality control strategies. However, ICH quality guidelines lacked a guideline for analytical procedure development, and ICH Q2 analytical procedure validation guideline had not been revised for a long time. In 2018, an Expert Working Group was organized to create a new ICH Q14 guideline for analytical procedure development and to revise ICH Q2 guideline, then the guideline development process began. At the ICH Prague meeting in November 2023, ICH Q2(R2)/Q14 reached Step 4 (international harmonization). Applying the “Enhanced approach” provided by ICH Q14, in other words “analytical Quality by Design (QbD)”, could bring deeper understanding of analytical procedures, improved robustness of them, and more flexible lifecycle management of analytical procedures. Therefore, it is expected that the use of analytical QbD will increase in the future. However, there are limited examples of application of analytical QbD to the analytical procedures of biopharmaceuticals, even though examples are provided in ICH Q2(R2)/Q14 training materials. This review will first outline the major points of ICH Q2(R2)/Q14, and then explain the key points of a case study applying analytical QbD, such as lifecycle of Analytical Target Profile (ATP) and risk management, to commonly used analytical procedures in biopharmaceuticals.