About ICH: The International
Council for Harmonisation(ICH), formerly the International Conference on
Harmonisation (ICH) held the inaugural Assembly meetings on 23 October 2015
establishing ICH as an international association, a legal entity under Swiss
law.
This step built
upon a 25-year track record of successful delivery of harmonised guidelines for
global pharmaceutical development as well as their regulation, and a longer
standing recognition of the need to harmonise.
Download An Overview on ICH:
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Quality Guideline
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Name of Guideline
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Download PDF Link
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Stability
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Q1A(R2)
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Stability Testing of New
Drug Substances and Products (Second Revision)
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Q1B
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Stability Testing:
Photostability Testing of New Drug Substances and Products
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Q1C
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Stability Testing for New
Dosage Forms
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Q1D
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Bracketing and Matrixing
Designs for Stability Testing of New Drug Substances and Products
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Q1E
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Evaluation for Stability
Data
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Q1F*
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Stability Data Package
for Registration Applications in Climatic Zones III and IV
(Guideline
withdrawn in June 2006).
Explanatory Note on the
Withdrawal of ICH Q1F for the ICH Website
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Validation
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Q2(R1)
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Validation of Analytical
Procedures: Text and Methodology (The
Addendum dated November 1996 has been incorporated into the core guideline in
November 2005).
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Impurities
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Q3A(R2)
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Impurities in New Drug
Substances
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Q3B(R2)
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Impurities in New Drug
Products
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Q3C(R6)
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Impurities: Guideline for
Residual Solvents (including the two
Revised PDE for THF and NMP dated September 2002 and October 2002
incorporated in core Guideline in November 2005 and revised PDE for Cumene
incorporated in core Guideline in February 2011)
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Q3D
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Guideline for Elemental
Impurities
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Pharmacopoeia
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Q4B
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Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
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Q4B Annex 1(R1)
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Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue
on Ignition/Sulphated Ash General Chapter
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Q4B Annex 2(R1)
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Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for
Extractable Volume of Parenteral Preparations General Chapter
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Q4B Annex 3(R1)
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Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for
Particulate Contamination: Sub-Visible Particles General Chapter
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Q4B Annex 4A(R1)
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Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Microbiological Examination of Non-Sterile Products: Microbial Enumeration
Tests General Chapter
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Q4B Annex 4B(R1)
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Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Microbiological Examination of Non-Sterile Products: Tests for Specified
Micro-Organisms General Chapter
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Q4B Annex 4C(R1)
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Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Microbiological Examination of Non-Sterile Products: Acceptance Criteria for
Pharmaceutical Preparations and Substances for Pharmaceutical Use General
Chapter
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Q4B Annex 5(R1)
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Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Disintegration Test General Chapter
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Q4B Annex 6
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Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Uniformity of Dosage Units General Chapter
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Q4B Annex 7(R2)
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Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Dissolution Test General Chapter
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Q4B Annex 8(R1)
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Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Sterility Chapter General Chapter
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Q4B
Annex 9(R1)
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Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Tablet
Friability General Chapter
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Q4B
Annex 10(R1)
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Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Polyacrylamide Gel Electrophoresis General Chapter
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Pharmacopoeia
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Q4B
Annex 11
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Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Capillary Electrophoresis General Chapter
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Q4B
Annex 12
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Evaluation and Recommendation
of Pharmacopoeial Texts for Use in the ICH Regions on Analytical Sieving
General Chapter
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Q4B Annex 13
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Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bulk
Density and Tapped Density of Powders General Chapter
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Q4B Annex 14
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Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Bacterial Endotoxins Test General Chapter
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Quality of
Biotechnological Products
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Q5A(R1)
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Viral Safety Evaluation
of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
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Q5B
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Quality of
Biotechnological Products: Analysis of the Expression Construct in Cells Used
for Production of R-DNA Derived Protein Products
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Q5C
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Quality of
Biotechnological Products: Stability Testing of Biotechnological/Biological
Products
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Q5D
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Derivation and
Characterisation of Cell Substrates Used for Production of Biotechnological/
Biological Products
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Q5E
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Comparability of
Biotechnological/Biological Products Subject to Changes in Their Manufacturing
Process
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Specifications
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Q6A
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Specifications : Test
Procedures and Acceptance Criteria for New Drug Substances and New Drug
Products : Chemical Substances
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Q6B
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Specifications: Test
Procedures and Acceptance Criteria for Biotechnological/Biological Products
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Good Manufacturing
Practice
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Q7
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Good Manufacturing
Practice Guide for Active Pharmaceutical Ingredients
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Pharmaceutical
Development
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Q8(R2)
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Pharmaceutical
Development
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Quality Risk Management
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Q9
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Quality Risk Management
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Pharmaceutical Quality System
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Q10
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Pharmaceutical Quality
System
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Development and
Manufacture of Drug Substances
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Q11
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Development and
Manufacture of Drug Substances (Chemical Entities and
Biotechnological/Biological Entities)
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