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ICH Quality Guidelines
Q1 through Q10


Q1A(R2) - Stability Testing of New Drug Substances and Products
Q1B - Stability Testing: Photostability Testing of New Drug Substances and Stability Testing for New Dosage Forms. Annex to the ICH Harmonised Tripartite Guideline on Stability Testing for New Drugs and Products
Q1C - Stability Testing for New Dosage Forms. Annex to the ICH Harmonised Tripartite Guideline on Stability Testing for New Drugs and Products
Q1D - BRACKETING AND MATRIXING DESIGNS FOR STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
Q1E - EVALUATION FOR STABILITY DATA
Q1F - STABILITY DATA PACKAGE FOR REGISTRATION APPLICATIONS IN CLIMATIC ZONES III AND IV
Q2(R1) - VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY
Q3A(R2) - IMPURITIES IN NEW DRUG SUBSTANCES
Q3B(R2) - IMPURITIES IN NEW DRUG PRODUCTS
Q3C(R3) - IMPURITIES:  GUIDELINE FOR RESIDUAL SOLVENTS
Q4B - ANNEX I - REGULATORY ACCEPTANCE OF ANALYTICAL PROCEDURES AND/OR ACCEPTANCE CRITERIA (RAAPAC) ON RESIDUE ON IGNITION/SULPHATED ASH GENERAL CHAPTER ANALYTICAL PROCEDURES AND/OR ACCEPTANCE CRITERIA (APAC)
Q4B - REGULATORY ACCEPTANCE OF ANALYTICAL PROCEDURES AND/OR ACCEPTANCE CRITERIA (RAAPAC)
Q5A(R1) - VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN
Q5B - QUALITY OF BIOTECHNOLOGICAL PRODUCTS: ANALYSIS OF THE EXPRESSION CONSTRUCT IN CELLS USED FOR PRODUCTION OF R-DNA DERIVED PROTEIN PRODUCTS
Q5C - QUALITY OF BIOTECHNOLOGICAL PRODUCTS:STABILITY TESTING OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS
Q5D - DERIVATION AND CHARACTERISATION OF CELL SUBSTRATES USED FOR PRODUCTION OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS
Q5E - COMPARABILITY OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESS
Q6A - SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS: CHEMICAL SUBSTANCES
Q6A - DECISION TREE #1: ESTABLISHING ACCEPTANCE CRITERION
FOR A SPECIFIED IMPURITY IN A NEW DRUG SUBSTANCE
Q6B - SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS
Q7- GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS
Q8 - PHARMACEUTICAL DEVELOPMENT
Q9 - QUALITY RISK MANAGEMENT
Q10 - PHARMACEUTICAL QUALITY SYSTEM
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