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Quality Guidelines
New Codification as per November 2005

Stability
Stability Testing of New Drug Substances and
Q1A(R2)
Products
Stability Testing : Photostability Testing of
Q1B
New Drug Substances and Products
Q1C Stability Testing for New Dosage Forms
Bracketing and Matrixing Designs for Stability
Q1D Testing of New Drug Substances and
Products
Q1E Evaluation of Stability Data
Stability Data Package for Registration
Q1F
Applications in Climatic Zones III and IV

Analytical Validation
Q 2 ( R 1 ) New title: Validation of Analytical Procedures: Q2A
Text and Methodology
Previously: Text on Validation of Analytical
Procedures
Validation of Analytical Procedures: Q2B
Methodology (in Q2(R1))

Impurities
Q3A(R2) Impurities in New Drug Substances Q3A(R)
Q3B(R2) Impurities in New Drug Products Q3B(R)
Q3C(R4) Impurities: Guideline for Residual Solvents Q3C
Impurities: Guideline for Residual Solvents Q3C(M)
(Maintenance)
PDE for Tetrahydrofuran (in Q3C(R3))
PDE for N-Methylpyrrolidone (in Q3C(R3)) Q3C(M)
PDE for Cumene
Procedures are described here

Pharmacopoeias
Q4 Pharmacopoeias
Q4A Pharmacopoeial Harmonisation
Q4B Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the ICH

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Regions
Q4B Evaluation and Recommendation of
Annex Pharmacopoeial Texts for Use in the ICH
1(R1) Regions
on Residue on Ignition/Sulphated Ash
General Chapter
Q4B Evaluation and Recommendation of
Annex Pharmacopoeial Texts for Use in the ICH
2(R1) Regions
on Test for Extractable Volume of Parenteral
Preparations General Chapter
Q4B Evaluation and Recommendation of
Annex Pharmacopoeial Texts for Use in the ICH
3(R1) Regions
on Test for Particulate Contamination: Sub-
Visible Particles General Chapter
Q4B Evaluation and Recommendation of
Annex Pharmacopoeial Texts for Use in the ICH
4A(R1) Regions
on Microbiological Examination of Non-Sterile
Products: Microbial Enumeration Tests
General Chapter
Q4B Evaluation and Recommendation of
Annex Pharmacopoeial Texts for Use in the ICH
4B(R1) Regions
on Microbiological Examination of Non-Sterile
Products: Tests for Specified Micro-organisms
General Chapter
Q4B Evaluation and Recommendation of
Annex Pharmacopoeial Texts for Use in the ICH
4C(R1) Regions
on Microbiological Examination of Non-Sterile
Products: Acceptance Criteria for
Pharmaceutical Preparations and Substances
for Pharmaceutical Use General Chapter
Q4B Evaluation and Recommendation of
Annex Pharmacopoeial Texts for Use in the ICH
5(R1) Regions
on Disintegration Test General Chapter
Q4B Evaluation and Recommendation of Pharmacopoeial Texts
Annex for Use in the ICH Regions
6(R1) on Uniformity of Dosage Units General Chapter
Q4B Evaluation and Recommendation of Pharmacopoeial Texts
Annex for Use in the ICH Regions
on Dissolution Test General Chapter

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7(R2)
Q4B Evaluation and Recommendation of Pharmacopoeial Texts
Annex for Use in the ICH Regions
8(R1) on Test for Sterility General Chapter
Q4B Evaluation and Recommendation of Pharmacopoeial Texts
Annex for Use in the ICH Regions
9(R1) on Tablet Friability General Chapter
Q4B Evaluation and Recommendation of Pharmacopoeial Texts
Annex for Use in the ICH Regions
10(R1) on Polyacrylamide Gel Electrophoresis General Chapter
Q4B Evaluation and Recommendation of Pharmacopoeial Texts
Annex for Use in the ICH Regions
11 on Capillary Electrophoresis General Chapter
Q4B Evaluation and Recommendation of Pharmacopoeial Texts
Annex for Use in the ICH Regions
12 on Analytical Sieving General Chapter
Q4B Evaluation and Recommendation of Pharmacopoeial Texts
Annex for Use in the ICH Regions
13 on Bulk Density and Tapped Density of Powders General
Chapter
Q4B Evaluation and Recommendation of Pharmacopoeial Texts
Annex for Use in the ICH Regions
14 on Bacterial Endotoxins Test General Chapter

Quality of Biotechnological Products

Q5A(R1) Viral Safety Evaluation of Biotechnology Q5A
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

Specifications

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Q6A Specifications : Test Procedures and

Acceptance Criteria for New Drug Substances
and New Drug Products: Chemical Substances
(including Decision Trees)
Q6B Specifications : Test Procedures and
Acceptance Criteria for
Biotechnological/Biological Products

Good Manufacturing Practice

Q7 Good Manufacturing Practice Guide for Active Q7A
Pharmaceutical Ingredients

Pharmaceutical Development
Q8(R2) Pharmaceutical Development

Quality Risk Management

Q9 Quality Risk Management

Pharmaceutical Quality System

Q10 Pharmaceutical Quality System

Q8/9/10
Q&As Q8/Q9/Q10 - Questions & Answers document
(R4)

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