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ICH Guidelines

The document outlines guidelines published by the International Conference on Harmonisation (ICH) related to quality, safety, and efficacy of pharmaceuticals. It discusses ICH guidelines that provide guidance on stability testing, analytical validation, impurities, pharmacopoeias, quality of biotechnological products, specifications, good manufacturing practice, and more. It also covers safety guidelines for carcinogenicity studies, genotoxicity, toxicity testing, reproductive toxicology, and nonclinical evaluation of pharmaceuticals. Finally, it mentions efficacy guidelines related to clinical safety, clinical study reports, dose-response studies, and clinical evaluation.

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aakash saha
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538 views4 pages

ICH Guidelines

The document outlines guidelines published by the International Conference on Harmonisation (ICH) related to quality, safety, and efficacy of pharmaceuticals. It discusses ICH guidelines that provide guidance on stability testing, analytical validation, impurities, pharmacopoeias, quality of biotechnological products, specifications, good manufacturing practice, and more. It also covers safety guidelines for carcinogenicity studies, genotoxicity, toxicity testing, reproductive toxicology, and nonclinical evaluation of pharmaceuticals. Finally, it mentions efficacy guidelines related to clinical safety, clinical study reports, dose-response studies, and clinical evaluation.

Uploaded by

aakash saha
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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 ICH Guidelines

 Quality Guidelines

 Stability Q1A- Q1F


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

Analytical validation Q2

Q2(R1) Validation of Analytical Procedures: Text and Methodology

 Impurities Q3A - Q3D



Q3A(R2) Impurities in New Drug Substances
 Q3B(R2) Impurities in New Drug Products
 Q3C(R5) Impurities: Guideline for Residual Solvents
 Q3D Impurities: Guideline for Elemental Impurities

 Pharmacopoeias Q4 - Q4B

Q4 Pharmacopoeias
 Q4A Pharmacopoeial Harmonisation
 Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
 Q4B Annex 1R1Residue on Ignition/Sulphated Ash General Chapter
 Q4B Annex 2R1Test for Extractable Volume of Parenteral Preparations General Chapter
 Q4B Annex 3R1Test for Particulate Contamination: Sub-Visible Particles General Chapter
 Q4B Annex 4AR1Microbiological Examination of Non-Sterile Products: Microbial Enumeration
Tests General Chapter
 Q4B Annex 4BR1Microbiological Examination of Non-Sterile Products: Tests for Specified
Micro-Organisms General Chapter
 Q4B Annex 4CR1Microbiological Examination of Non-Sterile Products: Acceptance Criteria
for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
 Q4B Annex 5R1Disintegration Test General Chapter
 Q4B Annex 6Uniformity of Dosage Units General Chapter
 Q4B Annex 7R2Dissolution Test General Chapter
 Q4B Annex 8R1Sterility Test General Chapter
 Q4B Annex 9R1Tablet Friability General Chapter
 Q4B Annex 10R1Polyacrylamide Gel Electrophoresis General Chapter
 Q4B Annex 11Capillary Electrophoresis General Chapter
 Q4B Annex 12Analytical Sieving General Chapter
 Q4B Annex 13Bulk Density and Tapped Density of Powders General Chapter
 Q4B Annex 14Bacterial Endotoxins Test General Chapter
 Q4B FAQsFrequently Asked Questions

 Quality of Biotechnological Products Q5A - Q5E



Q5A(R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of
Human or Animal Origin
 Q5B Analysis of the Expression Construct in Cells Used for Production of r-DNA
Derived Protein Products
 Q5C 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 Q6A- Q6B

 Good Manufacturing Practice Q7

 Pharmaceutical Development Q8

 Quality Risk Management Q9

 Pharmaceutical Quality System Q10

 Development and Manufacture of Drug Substances Q11

Safety Guidelines

 Carcinogenicity Studies S1A - S1C

 Genotoxicity Studies S2

 Toxicokinetics and Pharmacokinetics S3A - S3B

 Toxicity Testing S4

 Reproductive Toxicology S5
 Biotechnological Products S6

 Pharmacology Studies S7A - S7B

 Immunotoxicology Studies S8

 Nonclinical Evaluation for Anticancer Pharmaceuticals S9

 Photosafety Evaluation S10

Efficacy Guidelines

 Clinical Safety E1 - E2F

 Clinical Study Reports E3

 Dose-Response Studies E4

 Ethnic Factors E5

 Good Clinical Practice E6

 Clinical Trials E7 - E11

 Clinical Evaluation by Therapeutic Category E12

 Clinical Evaluation E14

 Pharmacogenomics E15 - E16

 Multidisciplinary Guidelines

 MedDRA Terminology M1

 Electronic Standards M2

 Nonclinical Safety Studies M3

 Common Technical Document M4


 Data Elements and Standards for Drug Dictionaries M5

 Gene Therapy M6

 Genotoxic Impurities M7

 Electronic Common Technical Document (eCTD) M8

SOP
In clinical research, the International Conference on Harmonisation (ICH) defines SOPs as "detailed,
written instructions to achieve uniformity of the performance of a specific function". SOPs get usually
applied in pharmaceutical processing and for related clinical studies. There the focus is set on always
repeated applying of unchanged processes and procedures and its documenting, hence supporting the
segregation of origins, causes and effects. Further application is with triage, when limited resources get
used according to an assessment on ranking, urgence and staffing possibilities. [1] Study director is mainly
responsible for SOPs. The Quality Assurance Unit are individuals who are responsible for monitoring
whether the study report and tests are meeting the SOP.

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