FDAnews Drug Daily Bulletin

ICH to Issue Clarifying Q&A on Q7 Guideline on API GMPs

Dec. 17, 2012
The International Conference on Harmonisation (ICH) is developing a question-and-answer guidance clarifying its Q7 standard on GMPs for active pharmaceutical ingredients (API). ICH has laid out several goals for the new Q&A to achieve, including clarifying issues related to supply chain control, outsourcing, monitoring of impurity profiles, quality systems and expectations in manufacturing APIs for clinical trials.
Drug GMP Report