Module 3 2019

ICH Quality Guidelines

ICH Guideline

Year

Q1A - Q1F Stability

1992 – 2006

Q2 Analytical Validation

1994 in revision, potentially combined with new Q14

Q3A - Q3D Impurities

1995 – 2019

Q4 - Q4B Pharmacopoeias

2006 – 2012

Q5A - Q5E Quality of Biotechnological Products

1999 - 2004

Q6A- Q6B Specifications

1997 - 1999

Q7 Good Manufacturing Practice

2000 – 2015

Q8 Pharmaceutical Development

2004 - 2010

Q9 Quality Risk Management

2005 – 2010

Q10 Pharmaceutical Quality System

2008 - 2010

Q11 Development and Manufacture of Drug Substances

2011 - 2012

Q12 Lifecycle Management

Step 4 in November 2019

Q13 Continuous Manufacturing of Drug Substances and Drug Products

Started in 2018

Q14 Analytical Procedure Development

Started in 2018

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