ICH Project Workshop on ICH Guidelines for Quality Implementation Working Group Notes

November 09, 2012

In order to promote progress in science- and risk-based approaches to pharmaceutical quality, the International Conference on Harmonization (ICH) has developed guidelines for "Drug Development" (Q8 (R2)), "Quality Risk Management" (Q9), and "Pharmaceutical Quality System" (Q10), which are already in effect in Japan. These guidelines have already entered into force in Japan. In order to clarify the common interpretation of these guidelines, the ICH Guidelines for Quality Implementation Working Group (Q-IWG) has developed six Points to Consider: "Guidelines for the implementation of ICH Q8, Q9, and Q10 as approved by the ICH", which include The MHLW issued an administrative communication on June 15, 2012 for three items: "Criticality of Quality Characteristics and Process Parameters," "Management Strategy," and "Degree of Documentation in Marketing Authorization Applications with More Advanced Methods (QbD). The remaining three items ("Role of models in Quality by Design (QbD)", "Design space", and "Process validation/continuous process check") were issued on February 1, 2013.
These Points to Consider are important not only for clarifying the interpretation of ICH Q8, Q9, and Q10 Guidelines, but also for the application for approval and the revision of GMP Enforcement Notification that is under consideration. The workshop will consist of lectures on the "Points to Consider", introduction of the "Guidelines", case studies, and panel discussion to promote understanding and wide application of the Guidelines. The workshop was attended by approximately 300 participants from a wide range of companies, and a lively question-and-answer session was held during the panel discussion.
The program, lecture timetable, and presentation materials for this symposium are attached below as files for direct viewing.
Unauthorized copying or reproduction of the attached materials is strictly prohibited.

Date, time and place

Information and Program

Program (313KB)

Lecture Materials

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