ICH pharmaceutical development Q8

Seminar By :
Raveena Udhani
M.Pharm 1st Semester
Pharmaceutical Quality
Assurance Department
Guided By:-
Dr. Rajesh Parikh
Director of
Graduate school of
Pharmacy
Graduate School Of Pharmacy,Gandhinagar

Introduction of ICH
 OBJECTIVE OF ICH
ICH LOCATION
GOAL OF ICH
MEMBERS OF ICH
ICH Q8 GUIDLINE INTRODUCTION
Q8 annexure
Quality by design
Example
References
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“International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceutical for Human use”
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 To make recommendation for achieving greater
harmonization in the interpretation and
application of technical guideline and
requirement for product registration.
 To reduce the need to duplicate the testing
carried out during the research and
development.
 To use human animal and material resources
economically .
 To eliminate unnecessary delay in the global
development and availability of new medicine.
 To decrease cost of health care to decrease the
cost of cost R&D and to meet the public
expectation so that there should be a minimum
delay in making safe and efficacious treatment.
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 The ICH secretariat in Geneva, Switzerland.
The biennial meetings and conferences of
the ICH Steering Committee rotate between
the EU, Japan and the USA.
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 ICH is comprised of representatives and research-bases industry
in the
I. European Union,
II. Japan
III. USA.
 In Japan, the members are the Ministry of Health, Labor and
Welfare(MHLW) and Japan Pharmaceutical Manufacturers
Association(JPMA).
 In Europe, the members are European Union(EU), and the
European Federation of Pharmaceutical Industries and
Associations(EFPIA).
 In USA the members are the Food and Drug
Administration(FDA). And the Pharmaceutical Research and
Manufactures of America(PhRMA).
 Additional members include Observers from the world Health
organization(WHO), European Free Trade Association(EFTA),
and Canada. The Observers represent non-ICH Countries and
regions.
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 The ICH structure consists of the
1. ICH stearing Committee
2. ICH Coordinators,
3. Ich Secretariat
4. ICH Working Groups.
 ICH Steering Committee
The Steering Committee is the body that governs the ICH,
determines the policies and procedures for ICH, selects topics
for harmonization and monitors the progress of
harmonization initiatives, each of the ICH parties has two
seat on the ICH Steering Committee.
 ICH Coordinators
The Coordinators are fundamental to the smooth running of
the ICH and are nominated by each of the parties. An ICH
Coordinator acts as the ICH Secretariat.
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ICH
SAFETY
EFFICACY
MULTIDISCPLINARY
QUALITY
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 “Quality” topic : i.e. relating to chemical
and pharmaceutical quality Assurance
(Stability Testing , Impurity Testing, Etc.)
 “Efficacy ”Topic: i.e. Those Relating To
Clinical studies in human subject(Dose
Response Studies, Good Clinical
Practices,Ect.)
 “Safety”Topic, : i.e., those relating to in
vitro and in vivo pre-
clinical,studies(Carcinogenicity
Testing,Genotoxicity Testing,Etc.)
 “Multidisciplinary”topics, i.e., cross-cutting
Topics Which do not fit uniquely into one of
the above categories.
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 Quality can not be tested in product it has to
be built in by design.
 Quality is never an accident it is always the
result of high intention , sincere effort ,
intelligent direction and skillful execution it
represents the wise choice of many
alternative.
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 It is emphasized that the quality of a
pharmaceutical product should be built in by
Design rather than by testing alone.
 The ICH Q8 guideline describes Good Practices
for pharmaceutical product Development.
 The pharmaceutical industry is one of the most
strictly regulated and its products are of
excellent quality.
 Qbd assures the quality of a pharmaceutical
product through scientific development and risk
management tools and will eventually enable
real-time release .regardless of the formulation
type.
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ICH pharmaceutical development Q8

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