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International Conference on Harmonisation - Quality

 Title and Format  Type  Issue Date
Q1A(R2) Stability Testing of New Drug Substances and Products Final 11/2003
Q1B Photostability Testing of New Drug Substances and Products Final 11/1996,
Q1C Stability Testing for New Dosage Forms  Final 5/9/1997
Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products Final 1/2003
Q1E Evaluation of Stability Data Final 6/2004
Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV, revision 1 Final Withdrawn 7/6/2006

Q2(R1) Validation of Analytical Procedures: Text and Methodology
Note: In November 2005, the ICH incorporated Q2B on methodology with the parent guidance Q2A and retitled the combined Q2 document. The contents of the two guidances were not revised.

 

 


Final
Final

 

 


3/1995
5/19/1997
Q3A(R) Impurities in New Drug Substances Final 6/6/2008
Q3B(R) Impurities in New Drug Products (Revision 2) Final 8/4/2006
Q3C Impurities: Residual Solvents Final 12/24/1997
Q3C Tables and List   Final 11/12/2003
Final
2/11/2002
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions Final 2/20/2007
Final 2/20/2007
Final 1/8/2009
Final 1/8/2009

 

 Final 4/7/2009
Draft 8/4/2008
Draft 2/13/2009

 

 Draft 8/13/2009
Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin

Final

 

 Posted 9/1998
Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products  

Final

 

 2/1996
Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products  Final 7/1996
Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability  (Issued , Posted 9/21/1998) Final 9/21/1998
Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process Final 6/2005
Q6A International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances. Final 12/29/2000
Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products Final 8/1999
Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients

Note: In November 2005, the ICH redesignated this guidance.  Q7 The guidance was not revised.


Final

 

 


8/2001

 

 
Q8(R2) Pharmaceutical Development Final 11/20/2009
Q9 Quality Risk Management  Final 6/1/2006
Q10 Pharmaceutical Quality System Final 4/7/2009
    
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