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Unnati Garg (ICH Guidelines)
Unnati Garg (ICH Guidelines)
ICH GUIDELINES
UNNATI GARG
M. Pharm (Pharmaceutics)
A10647021011
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INTRODUCTION
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STRUCTURE OF ICH
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GUIDELINES
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QUALITY SAFETY
MULTI-
EFFICACY
DISCIPLINARY
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QUALITY GUIDELINES
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• Q2 – Analytical Validation
• Q4 – Pharmacopoeias
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• Q8(R2) – Pharmaceutical development
• Q9 – Quality Risk management
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Q1A-Q1F
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Q2 – ANALYTICAL
VALIDATION Amity Institute of Pharmacy
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Q3A – Q3E – IMPURITIES
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Q4A: Pharmacopoeial Harmonization
The pharmacopoeial authorities, working together through
the Pharmacopoeial Discussion Group (PDG), have been closely
involved with the work of ICH since the outset and harmonisation
between the major pharmacopoeias, which started before ICH, has
proceeded in parallel.
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Q5A – Q5E – QUALITY OF BIOTECHNOLOGICAL
PRODUCTS Amity Institute of Pharmacy
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Q5C: Stability testing of Biotechnological/Biological
Products.
This document augments the stability Guideline (Q1A) and deals
with the particular aspects of stability test procedures needed to
take account of the special characteristics of products in which
the active components are typically proteins and/or polypeptides.
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Q6A - Q6B - Specifications
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Q8(R2) – PHARMACEUTICAL DEVELOPMENT
The Pharmaceutical Development section is intended to provide a
comprehensive understanding of the product and manufacturing
process for reviewers and inspectors.
Q9 – QUALITY RISK MANAGEMENT
This Guideline provides principles and examples of tools for
quality risk management that can be applied to different aspects
of pharmaceutical quality.
These aspects include development, manufacturing, distribution,
and the inspection and submission/review processes throughout
the lifecycle of drug substances
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Q11 – Development and Manufacture
of Drug Substances Amity Institute of Pharmacy
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Q12 – Lifecycle Management
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SAFETY GUIDELINES
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• S2 – Genotoxicity
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S5 – Reproductive
Toxicology Amity Institute of Pharmacy
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S6 – Biotechnological
Products Amity Institute of Pharmacy
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S7A – S7B – Pharmacology
Studies Amity Institute of Pharmacy
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S8 - Immunotoxicology
Studies Amity Institute of Pharmacy
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S9 – Nonclinical Evaluation
for Anticancer Amity Institute of Pharmacy
Pharmaceuticals
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S11 – Nonclinical
Paediatric Safety Amity Institute of Pharmacy
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EFFICACY GUIDELINES
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E1 – Clinical Safety for Drugs used in
Long Term Treatment Amity Institute of Pharmacy
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E2A- E2F -
Pharmacovigilance Amity Institute of Pharmacy
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E3 – E4
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E5 - E6 Amity Institute of Pharmacy
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E9 - E10
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E11 - E12 Amity Institute of Pharmacy
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E14 - E15 Amity Institute of Pharmacy
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E16 - E17
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E18 – Genomic
Sampling Amity Institute of Pharmacy
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MULTIDISCIPLINARY
GUIDELINES Amity Institute of Pharmacy
• M6: Gene Therapy
• M7: Mutagenic Impurities
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M1 - M2
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M4: CTD Amity Institute of Pharmacy
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M5: Data Elements and Standards
for Drug Dictionaries Amity Institute of Pharmacy
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M6: Gene Therapy
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M7: Mutagenic
Impurities Amity Institute of Pharmacy
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M8: Electronic Common
Technical Document Amity Institute of Pharmacy
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M9: Biopharmaceutics Classification
System-based Biowaivers Amity Institute of Pharmacy
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M9: Biopharmaceutics Classification
System-based Biowaivers Amity Institute of Pharmacy
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REFERNCE
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