ICH Pharma Quality Guideline

ICH Pharma Quality Guideline

ICH Guideline Link

1. ICH GUIDELINE INDEX

I. Q1A – Q1F STABILITY

Q1A (R2) Stability Testing of New Drug Substances and Products

Q1B Stability Testing: Photostability Testing of New Drug Substances and Products

Q1C Stability Testing for New Dosage Forms

Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products

Q1E Evaluation of Stability Data

Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV

Explanatory Note on the Withdrawal of ICH Q1F for the ICH Website

WHO Stability Guideline

II. Q2 ANALYTICAL VALIDATION

III. Q3A – Q3D IMPURITIES

Q3A(R2)Impurities in New Drug Substances

Q3B(R2)Impurities in New Drug Products

Q3C(R5)Impurities: Guideline for Residual Solvents

Q3DGuideline for Elemental Impurities

IV. Q4 – Q4B Pharmacopoeias

Q4B

Q4B Annex 1(R1)

Q4B ANNEX 2(R1)

Q4B ANNEX 3(R1)

Q4B ANNEX 4A(R1)

Q4B ANNEX 4B(R1)

Q4B ANNEX 4C (R1)

Q4B ANNEX 5(R1) DISINTEGRATION TEST

Q4B ANNEX 6 UNIFORMITY OF DOSAGE UNITS

Q4B ANNEX 7(R2) DISSOLUTION TEST

Q4B ANNEX 8(R1) STERILITY TEST

Q4B ANNEX 9(R1) TABLET FRIABILITY

Q4B ANNEX 10(R1) POLYACRYLAMIDE GEL ELECTROPHORESIS

Q4B ANNEX 11 CAPILLARY ELECTROPHORESIS

Q4B ANNEX 12 ANALYTICAL SIEVING

Q4B ANNEX 13 BULK DENSITY AND TAPPED DENSITY OF POWDERS

Q4B ANNEX 14 BACTERIAL ENDOTOXINS TEST

Q5A – Q5E Quality of Biotechnological Products

Q5A (R1)

Q5B

Q5C

Q5D

Q5E

VI. Q6A- Q6B Specifications

Q6A

DECISION TREE

Q6B

VII. Q7 Good Manufacturing Practice

VIII. Q8 Pharmaceutical Development

IX. Q9 Quality Risk Management

Q8/9/10 Points to Consider (R2)

X. Q10 Pharmaceutical Quality System

XI. Q11 Development and Manufacture of Drug Substances

 

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