ICH: Quality

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This page lists the scientific guidelines on quality of medicines published by the European Medicines Agency following agreement on a harmonised approach between Europe, Japan and the United States of America by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

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Table of contents

Stability

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Q 1 A (R2) Stability testing of new drug substances and productsAdopted guidelineCPMP/ICH/2736/99February 2003August 2003 
Q 1 B Photostability testing of new active substances and medicinal productsAdopted guidelineCPMP/ICH/279/95December 1996January 1998 
Q 1 C Stability testing: requirements for new dosage formsAdopted guidelineCPMP/ICH/280/95December 1996January 1998 
Q 1 D Bracketing and matrixing designs for stability testing of drug substances and drug productsAdopted guidelineCPMP/ICH/4104/00February 2002August 2002 
Q 1 E Evaluation of stability dataAdopted guidelineCPMP/ICH/420/02February 2003August 2003 
Q 1 F Stability data package for registration in climatic zones III and IVAdopted guidelineCPMP/ICH/421/02November 2000November 2000 

Analytical validation

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Q 2 (R1) Validation of analytical procedures: text and methodologyAdopted guidelineCPMP/ICH/381/95November 1994June 1995 

Impurities

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Q 3 A (R2) Impurities in new drug substancesAdopted guidelineCPMP/ICH/2737/99 Rev. 2February 2002August 2002 
Q 3 B (R2) Impurities in new drug productsAdopted guidelineCPMP/ICH/2738/99February 2003August 2003 
Q 3 C (R5) Impurities: guideline for residual solventsAdopted guidelineCPMP/ICH/82260/06March 2011August 2011 
Q 3 C (R6) Impurities: guideline for residual solventsDraft guidelineEMA/CHMP/ICH/82260/2006Released for consultation 4 August 2015 Deadline for commens 3 November 2015
Q 3 D Impurities: guideline on elemental impurities

Adopted guideline

Draft guideline

CHMP/ICH/353369/2013January 2015See guideline 

Regulatory acceptance

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Q 4 B Note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regionsAdopted guidelineCHMP/ICH/222007/06December 2007June 2008 
Q 4 B Annex 1 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on residue on ignition/sulphated ash general chapterAdopted guidelineCHMP/ICH/222063/06December 2007June 2008 
Q 4 B Annex 2 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for extractable volume of parenteral preparations general chapterAdopted guidelineCHMP/ICH/559409/07June 2008December 2008 
Q 4 B Annex 3 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for particulate contamination: sub-visible particles general chapterAdopted guidelineCHMP/ICH/561176/07June 2008December 2008 
Q 4 B Annex 4A to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on micrological examination of non-sterile products: micrological enumeration testsAdopted guidelineCHMP/ICH/308671/07December 2008June 2009 
Q 4 B Annex 4B to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for micrological examination of non-sterile products: tests for specified micro-organismsAdopted guidelineCHMP/ICH/308817/07December 2008June 2009 
Q 4 B Annex 4C to Note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for micrological examination of non-sterile products: acceptance criteria for pharmaceutical preparations and substances for pharmaceutical useAdopted guidelineCHMP/ICH/308867/08December 2008June 2009 
Q 4 B Annex 5 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on disintegration test general chapterAdopted guidelineCHMP/ICH/308895/08June 2009December 2009 
Q 4 B Annex 6 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on uniformity of dosage unites general chapter

Adopted guideline

Draft guideline

CHMP/ICH/645408/08January 2014 June 2014 
Q 4 B Annex 7 (R2) Dissolution test general chapterAdopted guidelineCHMP/ICH/645469/08December 2009May 2010 
Q 4 B Annex 8 Sterility test general chapterAdopted guidelineCHMP/ICH/645592/08June 2009December 2009 
Q 4 B Annex 9 Step 4 tablet friability general chapterAdopted guidelineCHMP/ICH/379801/09December 2009May 2010 
Q 4 B Annex 10 Step 4 polyacrylamide gel electrophoresisAdopted guidelineCHMP/ICH/381133/09December 2009May 2010 
ICH Topic Q8, Q9 and Q10 questions and answersDraft guidelineCHMP 265145/09December 2009December 2009 
Q 4 B Annex 11 Capillary electrophoresis - general chapter - step 4Adopted guideline
Draft guideline
CHMP/ICH/730028/09September 2010December 2010 
Q 4 B Annex 12 Analytical sieving - general chapter - step 4Adopted guideline
Draft guideline
CHMP/ICH/730808/09September 2010December 2010 
Q 4 B Annex 13 Bulk density and tapped density of powders - general chapter - step 4Adopted guideline
Draft guideline
CHMP/ICH/405290/10July 2012January 2013 
Q 4 B Annex 14 Bacterial endotoxins tests - general chapter - step 3

Adopted guideline

Draft guideline

CHMP/ICH/529785/10Dec 2012May 2013 

Quality of biotechnological products

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Q 5 A (R1) Viral safety evaluation of biotechnology products derived from cell lines of human or animal originAdopted guidelineCPMP/ICH/295/95April 1997October 1997 
Q 5 B Analysis of the expression construct in cell lines used for production of r-DNA derived protein productsAdopted guidelineCPMP/ICH/139/95December 1995July 1996 
Q 5 C Stability testing of biotechnological/biological productsAdopted guidelineCPMP/ICH/138/95December 1995July 1996 
Q 5 D Derivation and characterisation of cell substrates used for production of biotechnological/biological productsAdopted guidelineCPMP/ICH/294/95September 1997March 1998 
Q 5 E Comparability of biotechnological/biological productsAdopted guidelineCPMP/ICH/5721/03December 2004June 2005 

Specifications

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Q 6 A Test procedures and acceptance criteria for new drug substances and new drug products: chemical substancesAdopted guidelineCPMP/ICH/367/96November 1999May 2000 
Q 6 B Test procedures and acceptance driteria for biotechnological/biological productsAdopted guidelineCPMP/ICH/365/96March 1999September 1999 

Good manufacturing practice

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Q 7 Good manufacturing practice for active pharmaceutical ingredientsAdopted guidelineCPMP/ICH/4106/00November 2000November 2000 See also questions and answers on the guideline

Pharmaceutical development

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Q 8 (R2) Pharmaceutical developmentAdopted guidelineCHMP/ICH/167068/04November 2005May 2006See also questions and answers on the guideline
Q 9 Quality risk managementAdopted guidelineINS/GMP/79766/2011February 2011January 2006See also questions and answers on the guideline
Q 10 Note for guidance on pharmaceutical quality systemAdopted guidelineINS/GMP/79818/2011February 2011June 2008See also questions and answers on the guideline
Q 11 Development and manufacture of drug substances (chemical entities and biotechnological / biological entities), Step 4

Adopted guideline

Draft guideline

CHMP/ICH/425213/2011May 2012Nov 2012 

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