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Quality Control

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19 views

Quality Control

Uploaded by

myjourneyasim02
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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M.R.

COLLEGE
OF
PHARMACEUTICAL SCIENCES
AND RESEARCH
NAME- SUJOY SASMAL
CLASS ROLL - 116
COURSE - B.PHARM
SUBJECT CODE- PT-
516
SUBJECT-
PHARMACEUTICAL
JURISPRUDENCE
YEAR- 3rd YEAR
UNIVERSITY ROLL- 36301920008
SEMESTER – 6TH SEM
 TOPI
C

ICH GUIDELINES FOR


QUALITY,SAFETY,EFFICACY,MULTIDISCI
PLINARY
 INTERNATIONAL COUNCIL
FOR HARMONISATION

 Unique harmonisation initiatve for


regulators and pharmaceutical
industry.
 Originally founded in 1990.
 Reformed as a non-profit legal entity
under Swiss Law on 23 October 2015.
 What are ICH Guidelines

T h e I n te r n a t i o n a l Co u n c i l f o r H a r m o n i s a t i o n o f
Te c h n i c a l Re q u i re m e n t s f o r P h a r m a c e u t i c a l s f o r
H u m a n U s e ( I C H ) i s a p ro j e c t t h a t b r i n g s
to g e t h e r t h e re g u l a to r y a u t h o r i t i e s o f Eu ro p e,
J a p a n a n d t h e U n i te d S t a te s a n d ex p e r t s f ro m
t h e p h a r m a c e u t i c a l i n d u s t r y i n t h e t h re e
re g i o n s to d i s c u s s s c i e n t i f i c a n d te c h n i c a l
aspects.
 PURPOSE OF ICH:-

1) Promotion of public health through international


harmonisation that contributes to:
2) Prevention of unnecessary duplication of clinical
trials and post market clinical evaluations.
3) Development and manufacturing of new medicines.
while maintaining safeguards on quality, safety,
efficacy, and regulatory obligations to protect public
health.
4) Reduction of unnecessary animal testing without
compromising safety and effectiveness.
CATEGORIES

The ICH topics are divided into four categories and ICH topics codes
are assigned according to these categories :
Q : Quality Guidelines
S : Safety Guidelines
E : Efficacy Guidleines
M : Multidisciplinary Guidelines
 Quality Guide lin e s :-

 Harmonisation achievements in the Quality area include pivotal


milestones such as the conduct of stability studies, defining
relevant thresholds for impurities testing and a more flexible
approach to pharmaceutical quality based on Good Manufacturing
Practice (GMP) risk management.

Q1-Stability, Q2-Analytical Validation, Q3-Impurities, Q4-Pharmacopoeias,


Q5-Qualityof Biotechnological Products, Q6-Specifications, Q7-Good
Manufacturing Practice, Q8-Pharmaceutical Development, Q9-Quality Risk
Management, Q10-Pharmaceutical Quality System
SAFETY GUIDELINES

ICH has produced a comprehensive set of safety Guidelines to uncover


potential risks like carcinogenicity, genotoxicity and reprotoxicity. A
recent breakthrough has been a non-clinical testing strategy for
assessing the QT interval prolongation liability: the single most
important cause of drug withdrawals in recent years.

S1 -Carcinogenicity Studies, S2 -Genotoxicity Studies, S3 -Toxicokinetics


and Pharmacokinetics, S4- Toxicity Testing, S5- Reproductive
Toxicology,S6-Biotechnological Products,S7- Pharmacology Studies
S8- Immunotoxicology Studies
EFFICAC Y

The work carried out by ICH under the Efficacy heading is concerned
with the design, conduct, safety and reporting of clinical trials. It also
covers novel types of medicines derived from biotechnological processes
and the use of pharmacogenetics/genomics techniques to produce better
targeted medicines.

E1&E2-Clinical Safety, E3-Clinical Study Reports, E4-Dose-Response


Studies, E5-Ethnic Factors, E6-Good Clinical Practice,
E7,E8,E9,E10&E11-Clinical Trials, E12-Guidelines for Clinical
Evaluation, E14-Clinical Evaluation by Therapeutic Category,
E15&E16-Pharmacogenomics
 MULTIDISCIPLINARY

Those are the cross-cutting topics which do not fit uniquely into one of
the Quality, Safety and Efficacy categories. It includes the ICH medical
terminology (MedDRA), the Common Technical Document (CTD) and the
development of Electronic Standards for the Transfer of Regulatory
Information (ESTRI).

M1-MedDRA Terminology, M2-Electronic Standards, M3-Non-clinical


Safety Studies, M4-CTD, M5-Data elements & Standards for Drug
dictonaries, M6-Gene Theraphy, M7-Genotoxic Impurities, M8-eCTD
REFERENCE

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