International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

1. ICH GUIDELINES
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PRESENTED TO:
Dr. PRAKASH S GOUDANAVAR
HEAD OF THE DEPARTMENT
PHARMACEUTICS
SACCP
PRESENTED BY :
SAMEER
M PHARM
PHARMACEUTICS

2.  ICH is the “International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for Human Use.”
 ICH is a joint initiative involving both regulators and research-based industry
representatives of the EU, Japan and the US in scientific and technical
discussions of the testing procedures required to assess and ensure the safety,
quality and efficacy of medicines.
WHAT IS ICH……?
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3. The ICH Secretariat is based in Geneva. The biennial meetings and conferences of the
ICH Steering Committee rotate between the EU, Japan, and the USA.
ICH located
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4. To increase international harmonization of technical requirements to ensure that safe,
effective and high quality medicines are developed.
To harmonize technical requirements for registration or marketing approval.
To develop and register pharmaceuticals in the most efficient and cost effective manner.
To promote public health.
To prevent unnecessary duplication of clinical trials on humans.
Objectives of ICH
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5.  To promote international harmonization by bringing together representatives from the three
ICH regions (EU, Japan and USA)
 To discuss and establish common guidelines.
To make information available on ICH, ICH activities and ICH guidelines to any country or
company that requests the information
To promote a mutual understanding of regional initiatives in order to facilitate harmonization
processes related to ICH guidelines regionally and globally
To strengthen the capacity of drug regulatory authorities and industry to utilize them.
Goal of ICH
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6.  ICH is comprised of representatives from six parties that represent the regulatory bodies and
research-based industry in the European Union, Japan and the USA.
In Japan, the members are the Ministry of Health, Labour and Welfare (MHLW), and the
Japan Pharmaceutical Manufacturers Association (JPMA).
In Europe, the members are the European Union (EU), and the European Federation of
Pharmaceutical Industries and Associations (EFPIA).
In the USA, the members are the Food and Drug Administration (FDA), and the
Pharmaceutical Research and Manufacturers 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.
Members of ICH
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7. GUIDELINES
MULTIDISCIPLINARY
EFFICACY
SAFETY
QUALITY
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8. • "Quality" Topics i.e., those relating to chemical and pharmaceutical
Quality Assurance (Stability Testing, Impurity Testing, etc.
• “Efficacy" Topics, i.e., those relating to clinical studies in human subject
(Dose Response Studies, Good Clinical Practices, etc.)
• “Safety" Topics, 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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9. 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.
Consists of Q1A-Q1F, Q2, Q3A-Q3D, Q4-Q4B, Q5A-Q5E, Q6A-Q6B,
Q7, Q8, Q9, Q10, Q11 , Q12 ,Q13 & Q14
Quality Guidelines
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10. • QUALITY GUIDELINES
• Q1A - Q1F : Stability
• Q2 : Analytical Validation
• Q3A - Q3D : Impurities
• Q4 - Q4B : Pharmacopoeias
• Q5A - Q5E : Quality of Biotechnological Products
• Q6A- Q6B : Specifications
• Q7 : Good Manufacturing Practice
• Q8 : Pharmaceutical Development
• Q9 : Quality Risk Management
• Q10 : Pharmaceutical Quality System
• Q11 : Development and Manufacture of Drug Substances.
• Q12 : Lifecycle management
• Q13 : Continuous manufacturing of drug substance and drug products
• Q14 : Analaytical procedure development
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11. • Q1A-Q1F: Stability
Q1A(R2): Stability Testing of New Drug Substances and Products
Q1B: Stability Testing : Photostability Testing of New Drug Substances and
Products
Q1C: Stability Testing for New Dosage Forms
Q1D: Bracketing and Matrixing Designs for Stability Testing of New Drug
Substances
and Products
Q1E: Evaluation of Stability Data
Q1F: Stability Data Package for Registration Applications in Climatic Zones III
and IV.
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12. Q1A-Q1F STABILITY
Q1A – STABILITY TESTING OF NEW DRUGS SUSBTANCES AND PRODUCTS
• Stability testing provides evidence on how the quality of a drug substance or product
varies over a given time period and under the influence of environmental factors including
temperature, humidity and light.
• This Guideline provides recommendations on stability testing protocols including
temperature, humidity and trial duration for climatic Zone I and II.
• Furthermore, the revised document takes into account the requirements for stability
testing in Climatic Zones III and IV in order to minimise the different storage conditions
for submission of a global dossier.
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13. • Q2: Analytical Validation
The collection and evaluation of data generated from the process/method used in
making a product whether it is commercial, experimental or a scientific study.
Analytical validation consists of multiple steps and starts with a validation master plan.
The discussion of the validation of analytical procedures is directed to the four most common
types of analytical procedures:
- Identification tests;
- Quantitative tests for impurities' content
- Limit tests for the control of impurities
- Quantitative tests of the active moiety in samples of drug substance or drug product.
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• Q3A-Q3D: Impurities
 Impurities in a pharmaceutical product may be defined as unwanted chemicals in the
product that are not the active pharmaceutical ingredient (API) itself (or the excipients
used to manufacture it), or which develop during formulation or upon aging of both API
and formulation.
 They are unwanted chemicals that remain within the formulation or API in small amounts
and which can influence quality, safety and efficacy (QSE), thereby causing serious health
hazard.
Objective:
 The objective recommendation of the guide line makes to applicant on reporting,
identifying and qualifying information on impurities in new drug substance.
Q3A(R2): Impurities in New Drug Substances
Q3B(R2): Impurities in New Drug Products
Q3C(R5): Impurities: Guideline for Residual Solvents
Q3D: Guideline for Elemental Impurities
Q3D: Implementation of Guideline for Elemental Impurities.

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• Q4A-Q4B: Pharmacopoeias
• Derived from Greek word 'Pharmakon' means drug and 'Poiea' means to make.
• It is a legal and official book issued by recognized authorities usually appointed by
Government of each country.
• It comprises list of pharmaceutical substances, formulae along with their description and
standards.
Q4A:-Pharmacopeial Harmonisation
Q4B:-Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH
Regions.

16. • Q5A-Q5E: Quality of Biotechnological Products
Q5A(R1):-Viral Safety Evaluation of Biotechnology Products Derived from Cell
Lines of Human or Animal OriginQ5A
Q5B:- Analysis of the Expression Construct in Cells Used for Production of r-DNA
Derived Protein Products
Q5C:-Stability Testing of Biotechnological/Biological Products
Q5D:- Derivation and Characterization of Cell Substrates Used for Production of
Biotechnological/Biological Products
Q5E:-Comparability of Biotechnological/Biological Products Subject to Changes in
their Manufacturing Process.
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17. • Q6A-Q6B: Specifications
Q6A:-Specifications: Test Procedures and Acceptance Criteria for New
Drug Substances and New Drug Products: Chemical Substances
Q6B:-Specifications: Test Procedures and Acceptance Criteria for
Biotechnological/Biological Products.
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18. • Q7: Good Manufacturing Practice
Good manufacturing practice (GMP) is a system for ensuring that
products are consistently produced and controlled according to quality
standards. It is designed to minimize the risks involved in any
pharmaceutical production that cannot be eliminated through testing the
final product.
This document is intended to provide guidance regarding Good
Manufacturing Practice (GMP) for the manufacturing of Active
Pharmaceutical Ingredients (APIs) under an appropriate system for
managing quality.
In February 1998, the ICH Steering Committee agreed that GMP for
Active Pharmaceutical Ingredients (APIs) should be adopted as an ICH
Topic.
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19. Q8: Pharmaceutical Development
The aim of pharmaceutical development is to design a quality
product and its manufacturing process to consistently deliver the intended
performance of the product. The information and knowledge gained from
pharmaceutical development studies and manufacturing experience provide
scientific understanding to support the establishment of the design space*,
specifications, and manufacturing controls.
This annex describes the principles of quality by design (QbD). The
annex is not intended to establish new standards, however, it shows how
concepts and tools (e.g., design space) outlined in the parent Q8 document
could be put into practice by the applicant for all dosage forms.
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20. • Q9: Quality Risk Management
“A systematic process for the assessment, control, communication
and review of risks to the quality of the drug (medicinal) product across the
product lifecycle.”
OR
“ QRM is integral to an effective pharmaceutical quality system. It
can provide a proactive approach to identifying, scientifically evaluating &
controlling potential risks to quality. It facilitates continual improvement of
process performance & product quality throughout the product life cycle .”
QRM can be applied to different aspects of pharmaceutical quality
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CONT….
This Guideline provides principles and examples of tools of quality
risk management that can be applied to all aspects of pharmaceutical quality
including development, manufacturing, distribution, and the inspection and
submission/review processes throughout the lifecycle of drug substances and
drug (medicinal) products, biological and biotechnological products, including
the use of raw materials, solvents, excipients, packaging and labelling
materials.

22. Q1O:- PHARMACEUTICAL QUALITY SYSTEM
A Pharmaceutical Quality System (PQS) is a management system to direct and
control a pharmaceutical company in terms of quality.” This definition of ICH Q10 is based
on the definition from the family of ISO 9000 standards, with the primary objective of
ensuring the quality and efficacy of the medicinal product , and patient safety, while
improving the overall level of quality and the performance of the business.
This Guideline applies to pharmaceutical drug substances and drug products,
including biotechnology and biological products, throughout the product
lifecycle.
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23. • Q11: Development and Manufacture of Drug Substances
This new guidance is proposed for Active Pharmaceutical Ingredients (APIs)
harmonising the scientific and technical principles relating to the description
and justification of the development and manufacturing process (CTD
sections S 2.2. - S 2.6) of Drug Substances including both chemical entities
and biotechnological/biological entities.
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24. • This new Guideline is proposed to provide a framework to facilitate the
management of post-approval Chemistry, Manufacturing and Controls
(CMC) changes in a more predictable and efficient manner across the
product lifecycle.
• Adoption of this new ICH Guideline will promote innovation and continual
improvement in the biopharmaceutical sector, and strengthen quality
assurance and reliable supply of product, including proactive planning of
supply chain adjustments. It will allow regulators (assessors and
inspectors) to better understand the firms’ Pharmaceutical Quality Systems
(PQSs) for management of post-approval CMC changes.
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• Q12: Life cycle Management

25. Q13 : Continuous manufacturing of drug substance and drug
products
• Regulatory agencies are taking proactive steps to enable the
implementation of continuous manufacturing; they see it as a means “to
improve product quality and address many of the underlying causes of
drug shortages and recalls
• Provide guidance to industry and regulatory agencies regarding
regulatory expectations on the development, implementation, and
assessment of CM technologies used in the manufacture of drug
substances and drug products.
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26. Q14 :: Analaytical procedure development
• The new guideline is proposed to harmonise the scientific approaches of
Analytical Procedure Development, and to provide the principles
relating to the description of Analytical Procedure Development
process.
• This new guideline is intended to improve regulatory communication
between industry and regulators and facilitate more efficient, sound
scientific and risk-based approval as well as post-approval change
management of analytical procedures.
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27. REFERENCE
• https://www.ich.org/products/guidelines/quality/article/quali
ty-guidelines.html
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28. THANK YOU
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