ICH Project ICH Q7 "GMP Q&A for Active Pharmaceutical Ingredients" Briefing Session

Apr 26, 2016

In order to harmonize the pharmaceutical regulations of Japan, the U.S. and Europe for the purpose of simultaneous global development of pharmaceuticals and ensuring international drug safety, active discussions have been held at ICH and many results have already been achieved.
The Q&A for ICH Q7 (GMP for active pharmaceutical ingredients) became Step 4 on June 10, 2011, and was posted on the official ICH website. The Q&A of ICH Q7 (GMP for active pharmaceutical ingredients) was published on the official ICH website.
More than 10 years have passed since the GMP for APIs was issued as Step 4 in November 2000 and as a notification in Japan in November 2001. Through the operation of the GMP for APIs, the Q&A was reviewed to clarify ambiguities in the interpretation of the GMP guidelines for APIs and to add new concepts from Q8 to Q11 to the interpretation. The following is a summary of the Q7 Q&As.
In light of the issuance of Q7 Q&A in Japan, a briefing session on the contents of Q7 Q&A was recently held.

More than 320 business-related persons attended this briefing session, and a lively Q&A session was held, indicating the high level of interest among the participants.
The program, lecture timetable, and presentation materials for this briefing are attached below as files for direct viewing. Unauthorized copying or reproduction of the contents of the attached materials on this website is strictly prohibited.

Date, time and place

Information and Program

Program（276KB)

Lecture Materials

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