Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q&A Development & Status

• GMP’s for APIs and the general acceptance of ICH Q7 by regulators. • Specific focus on sections of ICH Q7 will be addressed for Q&A. • Justification for a Q&A associated with ICH Q7. • Importance of the quality agreement. • Development of PIC/s training for investigators. • Establishing the connection between ICH Q7 & ICH Q11 for change management associated with QbD.