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

April 26, 2016 Aiming

at simultaneous global development of pharmaceuticals and international assurance of drug safety, active discussions have been held at ICH to harmonize regulations for pharmaceuticals in Japan, the U.S. and Europe, and many results have already been achieved.
Q&A for

ICH

Q7 (GMP for active pharmaceutical ingredients) became Step 4 on June 10, 2011. and posted 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 ambiguities in the interpretation of the GMP guidelines have been clarified and the concepts from Q8 to Q11 have been discussed to add new concepts 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 of the meeting

Information and Program

Information and Program (276KB)

Lecture Materials

　

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