The document discusses the International Council for Harmonisation (ICH) guidelines related to pharmaceutical quality assurance, covering areas such as stability testing, impurities, good manufacturing practices, and clinical trial safety. It details the various categories and specific guidelines within quality, safety, and efficacy to ensure the safety, quality, and efficacy of medicines. Furthermore, it outlines essential considerations for regulatory compliance and risk management in the pharmaceutical industry.

1. QUALITY CONTROL AND QUALITY ASSURANCE
ASSIGNMENT SUBMITTED ON: ICH GUIDELINES
SUBMITTED TO: Dr.M.KRISHNAVENI HOD DEPARTMENT OF
PHARMACEUTICAL ANALYSIS
SUBMITTED BY: SWATHI.P I M.PHARM
PHARMACEUTICAL QUALITY ASSURANCE
SUBMITTED ON: 23/07/2019

2. ICH GUIDELINES
ICH GUIDELINES
• The International Council for harmonization of Technical
Requirements for Pharmaceuticals for Human Use (ICH).
• It is an initiative that brings together regulatory authorities and
pharmaceutical industries in the scientific and technical discussions
of procedures which are required to ensure safety, quality and
efficacy of medicines.
• The focus of ICH has been on the technical requirements for
medicinal products containing new drugs.
ICH Guidelines are divided into four categories , they are
Q •Stability
•Impurities testing
•GMP
S •Carcinogenicity
•Genotoxicity
•Reprotoxicity
E •Clinical trials
•Pharmacogenomics
M •MedDRA
•CTD
•Electronic Standards

3. Q S E M
ICH QUALITY GUIDELINES
S.NO Q.NO SUB
DIVISION
NAME OF THE GUIDELINES
1. Q1 Stability A(R2) Stability Testing of new Drug substances and Products
B Stability testing: Photostability Testing of New Drug
Substances and Products
C Stability Testing for New Dosage Forms
D Bracketing and Matrixing Designs for Stability Testing
of New Drug Substances and Products
E Evaluation of Stability Data
F Stability Data Package for Registration Applications in
Climatic Zones III and IV
2. Q2
Analytical
Validation
(R1) Validation of Analytical Procedures: Text and
Methodology
(R2)/Q14 Analytical Procedure Development and Revision of
Q2(R1) Analytical Validation
3. Q3
Impurities
A(R2) Impurities in New Drug Substances
B(R2) Impurities in New Drug Products
C(R7) Impurities: Guideline for Residual Solvents
Multidisciplinary
Guidelines: Cross-
cutting topics which do
not fit uniquely into one
of the Q,S&E. It includes
MedDRA,CTD and the
development of
Electronic Standards for
Transfer of Regulatory
Information(ESTRI).
Safety Guidelines:
Safety Guidelines to
uncover potential risks
like carcinogenicity,
genotoxicity and
reprotoxicity.
Efficacy Guidelines:
The work carried out by
ICH under the Efficacy
heading is concerned
with the design,
conduct , safety and
reporting of clinical
trials.
Quality
Guidelines:Harmonisation
Achievements in the
Quality area including
Stability studies,
impurities testing and a
more flexible approach to
Pharmaceutical quality
based on GMP risk
management.

4. C(R8) Impurities: Guideline for Residual Solvents
D(R1) Guideline for Elemental Impurities
D(R2) Revision of Q3D(R1) for cutaneous and transdermal
products
D training Implementation of Guideline for Elemental Impurities
4. Q4 Pharmacopoeias
A Pharmacopoeial Harmonization
B Evaluation and Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions
B Annex
1R1
Residue on Ignition/Sulphated ash General Chapter
B Annex
2R1
Test for Extractable Volume of Parenteral Preparations
General Chapter
B Annex
3R1
Test for Particulate Contamination : Sub-Visible
Particles General Chapter
B Annex
4AR1
Microbiological Examination of Non-Sterile Products:
Microbial Enumeration Tests General Chapter
B Annex
4BR1
Microbiological Examination of Non-Sterile Products:
Tests for Specified Micro-organisms General Chapter
B Annex
4CR1
Microbiological Examination of Non-sterile products:
Acceptance criteria for Pharmaceutical Preparations
and Substances for Pharmaceutical Use General
Chapter
B Annex
5R1
Disintegration Test General Chapter
B Annex 6 Uniformity of Dosage Units general Chapter
B Annex
7R2
Dissolution Test General Chapter
B Annex
8R1
Sterility Test General Chapter
B Annex
9R1
Tablet Friability General Chapter

5. B Annex
10R1
Polyacrylamide Gel Electrophoresis General Chapter
B Annex 11 Capillary Electrophoresis General Chapter
B Annex 12 Analytical Sieving General Chapter
B Annex 13 Bulk Density and Tapped Density of Powders General
Chapter
B Annex 14 Bacterial Endotoxins Test General Chapter
B FAQs Frequently Asked Questions
5. Q5 Quality
of
Biotechnolo
gical
Products
A(R1) Viral Safety Evaluation of Biotechnology Products
Derived from Cell Lines of Human or Animal Origin
B Analysis of the Expression Construct in Cells Used for
Production of r-DNA Derived Protein Products
C Stability Testing of Biotechnological/Biological
Products
D Derivation and Characterization of Cell Substrates
Used for Production of Biotechnological/Biological
Products
E Comparability of Biotechnological/Biological Products
Subject to Changes in their Manufacturing Process
6. Q6
Specification
s
A Specifications : Test Procedures and Acceptance
Criteria for New Drug Substances and New Drug
Products: Chemical Substances
B Specifications : Test Procedures and Acceptance
Criteria for Biotechnological/Biological Products
7. Q7 Good
Manufacturi
ng Practice
Good Manufacturing Practice Guide for Active
Pharmaceutical Ingredients
Q&As Questions and Answers: Good Manufacturing Practice
Guide for Active Pharmaceutical Ingredients
8. Q8
Pharmaceuti
R2 Pharmaceutical Development

6. cal
Developmen
t
Q8/9/10
Q&AsR4
Q8/Q9/Q10 – Implementation
9. Q9 Quality
Risk
Management
Quality Risk Management
Q8/9/10
Q&AsR4
Q8/Q9/Q10 – Implementation
10. Q10Pharmac
eutical
Quality
System
Pharmaceutical Quality System
11. Q11
Developmen
t and
Manufacture
of Drug
Substances
Development and Manufacture of Drug Substances
(Chemical Entities and Biotechnological/Biological
Entities)
12. Q&As Questions & Answers: Selection and Justification of
Starting Materials for the Manufacture of Drug
Substances
13. Q12
Lifecycle
Management
Technical and Regulatory Considerations for
Pharmaceutical Product Lifecycle Management
14. Q13
Continuous
Manufacturi
ng of Drug
Substances
and Drug
Products
Continuous Manufacturing of Drug Substances and
Drug Products
Q14
Analytical
Procedure
Developmen
Analytical Procedure Development

7. t
ICH SAFETY GUIDELINES
S.No SAFETY
NO
SUB
DIBISION
NAME OF THE GUIDELINE
1. S1
Carcinogeni
city studies
R1 Rodent Carcinogenicity Studies for Human
Pharmaceuticals
A Need for Carcinogenicity Studies of
Pharmaceuticals
B S1B
Testing for Carcinogenicity of Pharmaceuticals
C(R2) Dose Selection for Carcinogenicity Studies of
Pharmaceuticals
2. S2
Genotoxicity
studies
(R1) Guidance on Genotoxicity Testing and Data
Interpretation for Pharmaceuticals Intended for
Human Use
3. S3
Toxicokineti
cs and
Pharmacoki
netics
A Note for Guidance on Toxicokinetics: The
Assessment of Systemic Exposure in Toxicity
Studies
A Q&As Questions and Answers: Note for Guidance on
Toxicokinetics: The Assessment of Systemic
Exposure - Focus on Microsampling
B Pharmacokinetics: Guidance for Repeated Dose
Tissue Distribution Studies
4. S4 Toxicity
testing
Duration of Chronic Toxicity Testing in Animals
(Rodent and Non Rodent Toxicity Testing)
5. S5
Reproductiv
(R2) Detection of Toxicity to Reproduction for
Medicinal Products & Toxicity to Male Fertility

8. e
Toxicology
(R3) Revision of S5 Guideline on Detection of Toxicity
to Reproduction for Human Pharmaceuticals
6. S6
Biotechnolo
gical
Products
(R1) Preclinical Safety Evaluation of Biotechnology-
Derived Pharmaceuticals
7. S7
Pharmacolo
gical studies
A Safety Pharmacology Studies for Human
Pharmaceuticals
B The Non-Clinical Evaluation of the Potential for
Delayed Ventricular Repolarization (QT Interval
Prolongation) by Human Pharmaceuticals
E14/S7BQ&
As
E14/S7B Q&As
Questions & Answers: Clinical and non-Clinical
Evaluation of QT/QTc Interval Prolongation and
Proarrhythmic Potential
8. S8
Immunotoxi
cology
studies
Immunotoxicity Studies for Human
Pharmaceuticals
9. S9
Nonclinical
Evaluation
for
Anticancer
Pharmaceuti
cals
Nonclinical Evaluation for Anticancer
Pharmaceuticals
Q&As Questions and Answers: Nonclinical Evaluation for
Anticancer Pharmaceuticals
10. S10
Photosafety
Evaluation
Photosafety Evaluation of Pharmaceuticals
11. S11 Non-
clinical
Nonclinical Safety Testing in Support of
Development of Paediatric Medicines

9. paediatric
safety
ICH EFFICACY GUIDELINES
S.No EFFICACY
NO
SUB
DIVISION
NAME OF THE GUIDELINE
1. E1 Clinical
Safety for
Drugs Used
in Long-
Term
Treatment
The Extent of Population Exposure to Assess
Clinical Safety for Drugs Intended for Long-Term
Treatment of Non-Life Threatening Conditions
2. E2
Pharmacovi
gilance
A Clinical Safety Data Management: Definitions and
Standards for Expedited Reporting
B(R3) Clinical Safety Data Management: Data Elements
for Transmission of Individual Case Safety Reports
B(R3) Q&As Implementation: Electronic Transmission of
Individual Case Safety Reports
C (R2) Periodic Benefit-Risk Evaluation Report
C(R2) Q&As Questions & Answers: Periodic Benefit-Risk
Evaluation Report
D Post-Approval Safety Data Management:
Definitions and Standards for Expedited Reporting
E Pharmacovigilance Planning
F Development Safety Update Report
3. E3 Clinical
Study
Structure and Content of Clinical Study Reports

10. Reports
Q&As (R1) Questions & Answers: Structure and Content of
Clinical Study Reports
4. E4 Dose
Response
Studies
Dose-Response Information to Support Drug
Registration
5. E5 Ethnic
factors
(R1) Ethnic Factors in the Acceptability of Foreign
Clinical Data
Q&As (R1) Questions & Answers: Ethnic Factors in the
Acceptability of Foreign Clinical Data
6. E6 (R2) Good Clinical Practice (GCP)
7. E7 Clinical
Trials in
Geriatric
Population
Studies in Support of Special Populations:
Geriatrics
Q&As Questions & Answers: Studies in Support of
Special Populations : Geriatrics
8. E8 General
Considerati
ons for
Clinical
Trials
General Considerations for Clinical Trials
(R1) Revision on General Considerations for Clinical
Trials
9. E9
Statistical
Principles
for Clinical
Trials
Statistical Principles for Clinical Trials
(R1) Addendum: Statistical Principles for Clinical
Trials
10. E10 Choice
of Control
Group in
Choice of Control Group and Related Issues in
Clinical Trials

11. Clinical
Trials
11. E11
Clinical
Trials in
Paediatric
Population
(R1) Addendum: Clinical Investigation of Medicinal
Products in the Paediatric Population
A Paediatric Extrapolation
12. E12
Clinical
Evaluation
by
Therapeutic
Category
Principles for Clinical Evaluation of New
Antihypertensive Drugs
13. E14
Clinical
Evaluation
of QT
The Clinical Evaluation of QT/QTc Interval
Prolongation and Proarrhythmic Potential for
Non-Antiarrhythmic Drugs
Q&As(R3) Questions & Answers: The Clinical Evaluation of
QT/QTc Interval Prolongation and Proarrhythmic
Potential for Non-Antiarrhythmic Drugs
E14/S7B
Q&As
Questions & Answers: Clinical and non-Clinical
Evaluation of QT/QTc Interval Prolongation and
Proarrhythmic Potential
14. E15
Definitions
in
Pharmacog
enetics/Pha
rmacogeno
mics
Definitions for Genomic Biomarkers,
Pharmacogenomics, Pharmacogenetics, Genomic
Data and Sample Coding Categories
15. E16
Qualificatio
n of
Genomic
Biomarkers
Biomarkers Related to Drug or Biotechnology
Product Development: Context, Structure and
Format of Qualification Submissions
16. E17 Multi-
Regional
General principles for planning and design of
Multi-Regional Clinical Trials

12. Clinical
Trials
Training General principles for planning and design of
Multi-Regional Clinical Trials
17. E18
Genomic
Sampling
Genomic Sampling and Management of Genomic
Data
18. E19 Safety
Data
Collection
Optimization of Safety Data Collection
19. E20
Adaptive
clinical
Trials
Adaptive Clinical Trials
ICH MULTIDISCIPLINARY GUIDELINES
S.NO MULTIDIS
CIPLINAR
Y NO
SUB
DIVISION
NAME OF THE GUIDELINE
1. M1 MedRA
Terminolog
y
Medical Dictionary for Regulatory Activities
2. M2
Electronic
Standards
ESTRI Electronic Standards for the Transfer of
Regulatory Information
3. M3
Nonclinical
Safety
Studies
(R2) Guidance on Nonclinical Safety Studies for the
Conduct of Human Clinical Trials and Marketing
Authorization for Pharmaceuticals
(R2) Q&As
R2
Questions & Answers: Guidance on Non-Clinical
Safety Studies for the Conduct of Human Clinical
Trials and Marketing Authorization for
Pharmaceuticals
4. M4
Common
Technical
Document
CTD The Common Technical Document

13. 5. M5
Data
Elements
and
Standards
for Drug
Dictionaries
Data Elements and Standards for Drug
Dictionaries
6. M6 Gene
Therapy
Virus and Gene Therapy Vector Shedding and
Transmission
7. M7
Mutagenic
Impurities
(R1) Assessment and Control of DNA Reactive
(Mutagenic) Impurities in Pharmaceuticals to
Limit Potential Carcinogenic Risk
(R2) Assessment and Control of DNA Reactive
(Mutagenic) Impurities in Pharmaceuticals to
Limit Potential Carcinogenic Risk
8. M8
Electronic
Common
Technical
Document
(eCTD)
Electronic Common Technical Document (eCTD)
9. M9
Biopharmac
eutics
Classificatio
n System-
based
Biowaivers
Biopharmaceutics Classification System-based
Biowaivers
10. M10
Bioanalytic
al Method
Validation
Bioanalytical Method Validation
11. M11
Clinical
electronic
Structured
Harmonized
Protocol
(CeSHarP)
Clinical electronic Structured Harmonized
Protocol (CeSHarP)

14. 12. M12
Drug
Interaction
Studies
Drug Interaction Studies