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Japan Commits to Comparability Protocols as ICH Q12 Takes Shape

 
• By Bowman Cox

Japan’s decision to adopt comparability protocols will help smooth the way for the global post-approval changes that Q12 will enable.

In an important advance toward continual improvement of global pharmaceutical manufacturing processes, a Japanese regulatory official has promised that his agency will make it possible to use comparability protocols in Japan.

Comparability protocols give manufacturing processes a degree of fluidity over time by spelling out how companies can show specific changes in chemistry, manufacturing and

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