Professional Documents
Culture Documents
REPRESENTED BYKOMAL R. D.
M.PHARM.SEM-II
Guided By:
Dr. J.B.Dave
Dr. R. Badmanaban
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Introduction :
ICH established in 1990 as a joint
initiative involving both regulators
and research-based industry
representatives of the European
Union ,Japan and the USA in
scientific and technical discussion of
the testing procedures required to
assess and ensure the safety,
quality and efficacy of medicines.
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USA
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ICH Coordinators
The coordinators are fundamental
to the smooth running of the ICH and
are nominated by each of the six
parties .
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ICH Secretariat
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Safety (S)
Efficacy (E)
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
Q11:
DEVELOPMENT AND
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MANUFACTURE OF DRUG
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Q1 Stability Testing
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Bracketing
:-
50 mg
Batch
Container
15 ml
size
100ml
500ml
75 mg
100 mg
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Matrixing
Matrixing is the design of a stability schedule
such that a selected subset of the total number
of possible samples for all factor combinations
would be tested at a specified time point. At a
subsequent time point, another subset of
samples for all factor combinations would be
tested.
Strength S1
Batch 1
Batch 2
Batch 3
Batch 1
Batch 2
Batch 3
S2
12
T
T
T
T
18
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T
T
T
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Q2 : ANALYTICAL VALIDATION
This document presents a discussion of the
characteristics for consideration during the
validation of the analytical procedures
This text presentation serves as a collection of
terms, and their definitions, and is not intended to
provide direction on how to accomplish validation.
Validation Characteristics
1. Accuracy
4. Detection Limit
5. Quantitation Limit
Precision
Repeatability
6. Linearity
Intermediate Precision
7. Range
3. Specificity
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Q3 : IMPURITIES
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Q4 : PHARMACOPOEIAS
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Q5 : BIOTECHNOLOGICAL QUALITY
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Q6 : SPECIFIACATIONS
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Q8 : PHARMACEUTICAL DEVELOPMENT
The Pharmaceutical Development section provides
an opportunity to present the knowledge gained
through the application of scientific approaches and
quality risk management to the development of a
product and its manufacturing process.
The guideline does not apply to contents of
submissions for drug products during the clinical
research stages of drug development.
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Efficacy
E1
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E2D
Dose-response Information To
Support Drug
Registration
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E5
E10
Safety (S)
S1A
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S3A
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S7A
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Multidisciplinary topics
(M)
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REFERENCES
www.ich.org
Introduction of ICH
Quality
Safety
Efficacy
Multidisciplinary
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