ICH GUIDELINES

Prerna Waghmare​
CONTENTS
Introduction​
Purpose
Participants
Process of harmonization
A brief overview of QSEM with special
Emphasis on Q-series guidelines
ICH stability testing guidelines​
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INTRODUCTION
International conference on harmonization of technical
requirements to ensure that safe effective and high-quality
medicines are developed.
Origin:
• In the 1980s ICH was pioneered by the European council.
• WHO conference of drug regulatory authorities (ICDRA) in
Paris (1989) specific plan to materialize between the EU,
Japan, US.
• In 1990 April hosted EFPIA in Brussels give birth to ICH.
• Tokyo steering committee.
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The development of ICH is due to the thalidomide

tragedy.
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PRIMARY GOALS
Safety, Quality and Efficacy
Was non profit organisation
MISSION OF ICH
• Applications of technical guidelines and requirements for
Pharmaceutical product registration.
• Forum for constructive dialogue on scientific issue.
• Protection of public health.
• New technologies for the production of medicinal products.
 ORGANISATION 8

ICH

Regulatory bodies RnD Pharmaceutical Industries

Headquarters Geneva Switzerland.

Europe-
EFPIA (European federation of pharmaceutical Industry association)
EC (European commission)
America :
Us FDA
The pharmaceutical research and manufacturer America (PRMA)
Japan: Ministry health and laboratory welfare
Japan Manufacturing commission.
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ADDITIONAL MEMBERS
AND OBSERVER
Canada,
EFTA (European Free Trade Association)
Australia( Non – voting members)
IFPMA ( International federation of Pharmaceutical association)
representative
 Steering Committee 10

Med Dra Management

Global Cooperation board (Medicinal
Dictionary of Regulatory
activities)

Secretariat Coordinators

ICH Working group

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Global Cooperation group 12

Formed in 1999
Participants
• APEC: asia Pacific Economic Cooperation
• ASEAN: The association of Southeast Asian nation
• EAC: East African community
• GCC – Gulf Cooperation council
• PANDRH: Pan America Network on drug regulatory hamonisation
• SADC: The south African development community
Expansion of GCG:2007
• Australia
• Brazil
• China
• India
• Korea
• Russia
• Singapore
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COORINATORS
Maintain and smooth running
Main contact with secretariat

SECRETARIAT
Day-to-day management
Coordinating
Documentation
ICH WORKING GROUP
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EWG IWG InWG Discussion group

• Developing a Q nA for
harmonised guideline implementation
• Buisness plan
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MEMONICS
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SAI Pharma produces best quality

biotechnological products by following
specification and GMP for pharmaceutical
development.
Two Departments in company QRM and PQS
where there is less work.
They are working in DMDS Life cycle
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STABILITY TESTING GUIDELINES 19

Definition Objectives Scope General Principles

Accelerated testing Matrix

Bracketting

Commitment batches
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MATRIX 22
GENERAL PRINCIPLES
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• Expiry date
• The choice of the test condition.
• Mean Kinetic temperature.
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STABILITY TESTING GUIDELINES FOR 25

NEW DRUG SUBSTANCE

Stress testing:
• Degradation pathway, intrinsic stability of the molecule.
• Carried out in a Single batch, should include the effect of temperature at
100C humidity (eg 75% RH or greater)
• Evaluate susceptibility of the drug substance to hydrolysis across wide
range of PH value.
• Photostability is integral part.
PHOTO STABILITY 26

Testing photo stability should be conducted on atleast one primary batch.

Photo stability information for submission in registration does not cover the photostability of
drug after administration.

Objectives
If your DP/DS is resistant
To determine intrinsic photo stability charactersictics
Identify the precautionary measures to be taken during manufacturing/productions

Two studies :

• Forced Degradation
• Confirmatory studies
If confirmatory studies are non conclusive or misleading you can perform confirmatory studies on
2 more batches.
 SAMPLES
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Dark Control Directly exposed Immediate Pack Market PAck

Light sources

Option 1 Option 2
D65/ID65 Both cool white
fluorescent and near
ultraviolet
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