INDEX
WHAT IS ICH ?
HISTORY
INITIATION
INTRODUCTION
TOPICS
QUALITY GUDILINES
ICH
INTERNATIONAL CONFERENCE
ON HARMONISATION (ICH) OF
TECHNICAL REQUIREMENTS
FOR REGISTRATION OF
PHARMACEUTICALS FOR
HUMAN USE.
WHAT ?
An agreement between the
European Union (EU), Japan
and the United States (US)
• Joint initiative between
government regulators and
industry manufacturers.

WHY?

to harmonize regulatory
requirements for the
testing, application and
approval process of
pharmaceutical
medications.
Historical Overview
first attempt by the
European Commission
(EC) member nations
during the 1980’s
EC began bilateral
discussions with both
Japan and the United
States
Historical Overview
Specific plans began to
materialize at the World
Health Organization’s (WHO)
Conference on Drug
Regulatory Authorities in
Paris in 1989
ICH was created in April
1990 at a meeting
in Brussels
NEED FOR HARMONISATION
 RAPID INCREASE IN LAWS, REGULATIONS
ANG GUIDELINES FOR TESTING SAFETY,
QUALITY AND EFFICACY OF NEW
PRODUCTS
 DIFFERENT TECHNICAL REQUIREMENTS
BY REGULATORY AGENCIES , ALTHOUGH
FUNDAMENTAL GUIDING PRINCIPLES
SAME
 INDUSTRY BECOMING GLOBAL
 DUPLICATION OF TIME CONSUMING AND
EXPENSIVE TESTING
PROGRESS TOWARDS
INTERNATIONAL HARMONISATION
GOALS :
 DECREASE COUNTRY-TOCOUNTRY DIFFERENCES IN
GUIDELINES
 DECREASE DIFFERENCES
BETWEEN REGULATORY
AUTHORITIES
PROGRESS TOWARDS
INTERNATIONAL HARMONISATION
TARGET :
STREAMLINE DRUG
DEVELOPMENT AND
REGULATORY PROCESS
 INCREASE EFFICIENCY AND
ENFORCEMENT OF GMP, GLP
AND GCP GUIDELIENS

ICH FOUNDER MEMBERS
 EUROPEAN UNION :
 EUROPEAN COMMISSION (EU)
 EFPIA (EUROPEAN FEDERATION OF
PHARMACEUTICAL; INDUSTRIES,
ASSOCIATIONS)
 JAPAN :
 MINISTERY OF HEALTH AND WELFARE
 JPMA ( JAPAN PHARMACEUTICAL
MANUFACTURERS ASSOCIATION)
 USA :
 FDA
Initiation of ICH
 Formation of steering committee
 Agreement on terms of
references
 Expert working groups
 Eleven topics
 Four categories
Eleven possible topics to address
divided into four main categories
SAFETY
QUALITY
EFFICACY
MULTIDISCIPLINARY
An ICH
Guideline is
FDA Guidance
Expert Working Groups
STEERING COMMITTEE
Monitors and Facilitates EWGs
An EWG has 6 Topic Leaders - one from each ICH party
ICH Steering Committee
 Determines the policies and
procedures for ICH
 Selects topics for harmonization
 Monitors the progress of
harmonization initiatives
 Has two members for each of
the six co-sponsors, the IFPMA
and Observers
Expert Working Groups
 The Steering Committee assigns an
EWG to each of the technical topics
selected
 The groups are comprised of industry
specialists on the topics discussed
from each of the six members
 Do not have a fixed membership
QUALITY
 Q1 : STABILITY
 Q2 : ANALYTICAL VALIDATION
 Q3 : IMPURITIES
 Q4 : PHARMACOPOEIAS
 Q5 : BIOTECHNOLOGICAL QUALITY
 Q6 : SPECIFIACATIONS
 Q7 : GMP
 Q8 : PHARMACEUTICAL DEVELOPMENT
 Q9 : QUALITY RISK MANAGEMANT
 Q10: PHARMACEUTICAL QUALITY SYSTEM
Q1 Stability Testing
Q1A(R2) Stability Testing
of New Drug Substances
and Products
Q1B Photostability Testing
of New Drug Substances
and Products
Q1C Stability Testing for
New Dosage Forms
Q1 Stability Testing
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
Q2 Validation
Q2(R1) Validation of Analytical
Procedures: Text and
Methodology
Q2A Text on Validation of
Analytical Procedures
Q2B Validation of Analytical
Procedures: Methodology
Q3 Impurities
 Q3A(R) Impurities in New Drug
Substances
 Q3B(R) Impurities in New Drug
Products
 Q3C Impurities: Residual
Solvents
 Q3C Tables and List
Q4-Q4B Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
International Conference on Harmonisation
Regions
Annex I: Residue on
Ignition/Sulphated Ash General
Chapter
Annex 2: Test for Extractable
Volume of Parenteral
Preparations General Chapter
Annex 3: Test for Particulate
Contamination: Subvisible
Particles General Chapter
Annex 4A: Microbiological
Examination of Non-Sterile
Products: Microbial
Enumeration Tests General
Chapter
 Annex 4B: Microbiological
Examination of Non-Sterile
Products: Tests for Specified
Micro-organisms General
Chapter
 Annex 4C: Microbiological
Examination of Non-Sterile
Products: Acceptance Criteria for
Pharmaceutical Preparations and
Substances for Pharmaceutical
Use General Chapter
 Annex 5: Disintegration Test
General Chapter
 Annex 6:Uniformity of Dosage
Units General Chapter
 Annex 7:Dissolution Test
General Chapter
 Annex 8: Sterility Test General
Chapter
 Annex 9: Tablet Friability General
Chapter
 Annex 10: Polyacrylamide Gel
Electrophoresis General Chapter
 Annex 11: Capillary
Electrophoresis
General Chapter
 Annex 12: Analytical Sieving
General Chapter
Q5 BIOTECHNOLOGICAL
QUALITY
 Q5A Viral Safety Evaluation of
Biotechnology 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
Q5 BIOTECHNOLOGICAL
QUALITY
 Q5C Quality of Biotechnological Products:
Stability Testing of
Biotechnological/Biological Products
 Q5D Quality of Biotechnological/Biological
Products: Derivation and Characterization
of Cell Substrates Used for Production of
Biotechnological/Biological Products;
Availability
 Q5E Comparability of
Biotechnological/Biological Products Subject
to Changes in Their Manufacturing Process
Q6 SPECIFICATIONS
 Q6A International Conference on
Harmonisation; Guidance on Q6A
Specifications: Test Procedures and
Acceptance Criteria for New Drug
Substances and New Drug Products:
Chemical Substances
 Q6B Specifications: Test Procedures and
Acceptance Criteria for
Biotechnological/Biological Products
Q7A GMP Guidance for APIs
 This document is intended :
To provide guidance regarding GMP
for manufacturing of API under an
appropriate system for managing
quality
To ensure that API meets the
requirements of quality and purity
Q8(R2) Pharmaceutical Development
To design a quality
product and its
manufacturing process to
consistently deliver the
intended performance of
the product
Q9 Quality Risk Management
 It provides principles and examples
of tools for Quality Risk Management
that can be applied to different
aspects of pharmaceutical quality
such as :
Development
Manufacturing
Distribution
Inspection
Q10 Pharmaceutical Quality
System
It applies to Drug Substance
and Drug Product including
biotechnological and
biological products
throughout the lifecycle of
the product.
ICH 1
( NOVEMBER 1991)
DEVELOPMENT
OF TRIPARTITE
AGREEMENT
ICH 2 (OCTOBER 1993)
REVIEW OF PROGRESS
TOWARDS HARMONISATION
IN AREAS OF :
EFFEICACY
SAFETY
QUALITY
ICH 3 ( NOVEMBER 1995)
UPDATE STATUS OF :
TRIPARTITE AGREEMENT
PROGRESS TOWARDS
HARMONISATION
ICH 4 ( JULY 1997)
REIVIEW AND UPDATE OF
THE IMPEMENTATION
AND IMPACT OF ICH
GUIDELINES
ICH 5 ( NOEMBER 2000)
COMPLETION OF
CTD(M4)
ICH 6 ( NOVEMBER 2003)
continued development of
new guidances
did work on the
implementation of
existing guidelines
ANY QUESTIONS
?