EVOLUTION AND INTEGRATION OF QUALITY BY DESIGN AND PROCESS ANALYTICAL TECHNOLOGY - Quality by Design for Biopharmaceuticals - page 253

ONDQA
CMC Pilot
Program

PAT Guidance
for Industry

ACPS and FDA
Science Board

ICH Q10

ICH Q8

2001 2002 2003 2004 2005 2006 2007

ICH Q9

cGMP's for the twenty-first
century report

ICH Q8 R

cGMP's for the
twenty-first Century
Initiated

Critical path
initiative

Figure 13.1. FDA initiatives in QBD and PAT (with thanks to Dr Moheb Nasr).