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ICH GUIDELINES
PRESENTED BY:
ABDUL NAIM
M-PHARM I YEAR
PHARMACEUTICS
DEPARTMENT
ICH
• 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.
OBJECTIVES OF ICH :
• 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.
• To minimize the use of animal testing without compromising safety and effectiveness of
drug.
MEMBERS OF ICH:
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.
• Ministry of Health, Labor and Welfare (MHLW)
• Japan Pharmaceutical Manufacturers Association (JPMA)
In Japan
• European Union (EU),
• European Federation of Pharmaceutical Industries and Associations (EFPIA)
In Europe
• Food and Drug Administration (FDA)
• Pharmaceutical Research and Manufacturers of America (PhRMA)
In the USA
• Observers from the World Health Organization (WHO)
• European Free Trade Association (EFTA)
Additional members
*The Observers represent non-ICH countries and regions.
ICH
structure
ICH Assembly
ICH
Management
committee
MedDRA
Management
committee and
ICH
Secretariat
ICH ASSEMBLY: It works in bringing together all
Members and Observers of the ICH Association. It
takes decisions on particular matters such as on the
adoption of ICH Guidelines, admission of new
Members and Observers, and the ICH Associations
work plans and budget.
ICH MANAGEMENT COMMITTEE: It is that
body which supervises the operational aspects of
ICH on behalf of all Members, including
administrative and financial matters and oversight of
the Working Groups {WGs}.
MedDRA MANAGEMENT COMMITTEE: It is
responsible for managing, supporting, and
facilitating the maintenance, development of
MedDRA.
ICH SECRETARIAT: It is responsible for day-to-
day management of ICH, coordinating ICH activities
as well as providing support to the assembly, the MC
and Working Groups and MedDRA.
"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.
QUALITY GUIDELINES
Q1A-Q1F---STABILITY:
Q1A : Stability Testing of New Drug Substances and Products
The purpose of stability testing is to provide evidence on how the quality of a drug
substance or drug product varies with time under the influence of a variety of
environmental factors such as temperature, humidity, and light, and to establish a re-test
period for the drug substance or a shelf life for the drug product.
Q1B: Photostability Testing of New Drug Substances and Products Give guidance on
the basic testing protocol required to evaluate the light sensitivity and stability of new
drugs and products.
Q1C: Stability Testing for New Dosage Forms Gives guidelines for new formulations of
already approved medicines and defines the circumstances under which reduced stability
data can be accepted.
Q1D: Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and
products.
Q1E: Evaluation of Stability Data This guideline addresses the evaluation of stability data that
should be submitted in registration applications for new molecular entities and associated drug
products. The guideline provides recommendations on establishing shelf lives for drug substances
and drug products intended for storage at or below “room temperature”.
Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV. Describes
harmonized global stability testing requirements in order to facilitate access to medicines by
reducing the number of different storage conditions.
Q2-Analytical validation
Q2(R1): Validation of Analytical Procedures: Text and Methodology: The objective of validation of
an analytical procedure is to demonstrate that it is suitable for its intended purpose. Gives validation
parameters needed for a variety of analytical methods. It also discusses the characteristics that must
be considered during the validation of the analytical procedure.
Q3A- Q3D----Impurities
Q3A(R2): Impurities in New Drug Substances
The guideline addresses the chemistry and safety aspects of impurities, including the listing
of impurities, threshold limit, identification and quantification.
Classification of Impurities are of 3 types :
1. Organic impurities (process- and drug-related)
2. Inorganic impurities
3. Residual solvents
Q3B(R2): Impurities in New Drug Products
Q3C(R4): Impurities: Guideline for Residual Solvent
Benzene 2ppm Chlorobenzene 360ppm
Carbon tetrachloride 4ppm Formamide, Hexane 290ppm
Dichloromethane 5ppm Toluene 890ppm
Dichloroethane 8ppm Pyridine 200pm
Acetonitrile 410ppm Nitromethane 50ppm
Chloroform 60ppm Methanol 3000ppm
Q4: Pharmacopoeias
Q4A: Pharmacopeial Harmonization
Q4B: Evaluation and Recommendation of Pharmacopeial Texts for use in the ICH
regions.
This document describes a process for the evaluation and recommendation given by the
Q4B Expert Working Group (EWG) for selecting pharmacopeial texts to facilitate their
recognition by regulatory authorities for use, interchangeable in the ICH regions.
Q5A-Q5E---Quality of biotechnological products
Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines
of Human or Animal Origin
This document is concerned with testing and evaluation of the viral safety of biotechnology
products derived from cell lines of human or animal origin (i.e., mammalian, avian, insect).
The objective is to provide a general framework for virus testing experiments for the
evaluation of virus clearance and the design of viral tests and clearance evaluation studies.
Q5B: Quality of Biotechnological Products
Q5C: Stability Testing of Biotechnological/Biological Products.
Q5D: Derivation and Characterization of Cell Substrates Used for Production of
Biotechnological/Biological Products.
The objective of this guideline is to provide broad guidance on appropriate standards for cell
substrates.
Q5E: Comparability of Biotechnological/ Biological Products Subject to Changes in
Their Manufacturing Process
The objective of this document is to provide principles for assessing the comparability of
biotechnological/ biological products before and after changes are made in the manufacturing
process for the drug substance or drug product.
Therefore, this guideline is intended to assist in the collection of relevant technical
information which serves as evidence that the manufacturing process changes will not have
an adverse impact on the quality, safety and efficacy of the drug product.
Q6: Specifications for New Drug Substances and Products
Bulk drug substance and final product specifications are key parts of the core documentation
for world-wide product license applications.
This leads to conflicting standards for the same product, increased expenses and
opportunities for error as well as a potential cause for interruption of product supply.
Q6A: Specifications:
Test Procedures and Acceptance Criteria for New Drug Substances and New Drug
Products : Chemical Substances
The main objective of this guideline is to establish a single set of global specifications for
new drug substances and new drug products.
A specification is defined as a list of tests, references to analytical procedures, and
appropriate acceptance criteria, which are numerical limits, ranges.
This guideline addresses specifications, i.e., those tests, procedures, and acceptance criteria
which play a major role in assuring the quality of the new drug substance and new drug
product during shelf life.
Q6B: Specifications:
Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
This document provides guidance on justifying and setting specifications for proteins and
polypeptides which are derived from recombinant or non-recombinant cell cultures. A valid
biological assay to measure the biological activity should be provided by the manufacturer.
Examples of procedures used to measure biological activity include:
• Animal-based biological assays, which measure an organism's biological response to the
product;
• Cell culture-based biological assays, which measure biochemical or physiological
response at the cellular level;
• Biochemical assays, which measure biological activities such as enzymatic reaction rates
or biological responses induced by immunological interactions.
Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
The main objective of this guideline is that to maintain the quality of the active
pharmaceutical ingredients.
Q8(R2): Pharmaceutical Development
This guideline is intended to provide guidance on the contents of Pharmaceutical
Development of drug products.
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 Pharmaceutical
Development section also describe the type of dosage form and the formulation that are
suitable for the intended use.
Q8 gives information about Drug Substance, Excipients, Container Closure System.
Q9: Quality Risk Management
The purpose of this document is to offer a systematic approach to quality risk management.
This guideline provides principles and tools for 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 labeling materials.
Q10: Pharmaceutical Quality System
This document establishes a new ICH guideline describing a model for an effective
quality management system for the pharmaceutical industry, referred to as the
Pharmaceutical Quality System.
Comprehensive model for an effective pharmaceutical quality system is based on
International Standards Organization (ISO) quality concepts, includes applicable Good
Manufacturing Practice (GMP) regulations.
THANK YOU

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ICH GUIDELINES.pptx

  • 1. ICH GUIDELINES PRESENTED BY: ABDUL NAIM M-PHARM I YEAR PHARMACEUTICS DEPARTMENT
  • 2. ICH • 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. OBJECTIVES OF ICH : • 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. • To minimize the use of animal testing without compromising safety and effectiveness of drug.
  • 3. MEMBERS OF ICH: 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. • Ministry of Health, Labor and Welfare (MHLW) • Japan Pharmaceutical Manufacturers Association (JPMA) In Japan • European Union (EU), • European Federation of Pharmaceutical Industries and Associations (EFPIA) In Europe • Food and Drug Administration (FDA) • Pharmaceutical Research and Manufacturers of America (PhRMA) In the USA • Observers from the World Health Organization (WHO) • European Free Trade Association (EFTA) Additional members *The Observers represent non-ICH countries and regions.
  • 4. ICH structure ICH Assembly ICH Management committee MedDRA Management committee and ICH Secretariat ICH ASSEMBLY: It works in bringing together all Members and Observers of the ICH Association. It takes decisions on particular matters such as on the adoption of ICH Guidelines, admission of new Members and Observers, and the ICH Associations work plans and budget. ICH MANAGEMENT COMMITTEE: It is that body which supervises the operational aspects of ICH on behalf of all Members, including administrative and financial matters and oversight of the Working Groups {WGs}. MedDRA MANAGEMENT COMMITTEE: It is responsible for managing, supporting, and facilitating the maintenance, development of MedDRA. ICH SECRETARIAT: It is responsible for day-to- day management of ICH, coordinating ICH activities as well as providing support to the assembly, the MC and Working Groups and MedDRA.
  • 5. "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.
  • 6. QUALITY GUIDELINES Q1A-Q1F---STABILITY: Q1A : Stability Testing of New Drug Substances and Products The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug product. Q1B: Photostability Testing of New Drug Substances and Products Give guidance on the basic testing protocol required to evaluate the light sensitivity and stability of new drugs and products. Q1C: Stability Testing for New Dosage Forms Gives guidelines for new formulations of already approved medicines and defines the circumstances under which reduced stability data can be accepted.
  • 7. Q1D: Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and products. Q1E: Evaluation of Stability Data This guideline addresses the evaluation of stability data that should be submitted in registration applications for new molecular entities and associated drug products. The guideline provides recommendations on establishing shelf lives for drug substances and drug products intended for storage at or below “room temperature”. Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV. Describes harmonized global stability testing requirements in order to facilitate access to medicines by reducing the number of different storage conditions. Q2-Analytical validation Q2(R1): Validation of Analytical Procedures: Text and Methodology: The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose. Gives validation parameters needed for a variety of analytical methods. It also discusses the characteristics that must be considered during the validation of the analytical procedure.
  • 8. Q3A- Q3D----Impurities Q3A(R2): Impurities in New Drug Substances The guideline addresses the chemistry and safety aspects of impurities, including the listing of impurities, threshold limit, identification and quantification. Classification of Impurities are of 3 types : 1. Organic impurities (process- and drug-related) 2. Inorganic impurities 3. Residual solvents Q3B(R2): Impurities in New Drug Products Q3C(R4): Impurities: Guideline for Residual Solvent Benzene 2ppm Chlorobenzene 360ppm Carbon tetrachloride 4ppm Formamide, Hexane 290ppm Dichloromethane 5ppm Toluene 890ppm Dichloroethane 8ppm Pyridine 200pm Acetonitrile 410ppm Nitromethane 50ppm Chloroform 60ppm Methanol 3000ppm
  • 9. Q4: Pharmacopoeias Q4A: Pharmacopeial Harmonization Q4B: Evaluation and Recommendation of Pharmacopeial Texts for use in the ICH regions. This document describes a process for the evaluation and recommendation given by the Q4B Expert Working Group (EWG) for selecting pharmacopeial texts to facilitate their recognition by regulatory authorities for use, interchangeable in the ICH regions. Q5A-Q5E---Quality of biotechnological products Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin This document is concerned with testing and evaluation of the viral safety of biotechnology products derived from cell lines of human or animal origin (i.e., mammalian, avian, insect). The objective is to provide a general framework for virus testing experiments for the evaluation of virus clearance and the design of viral tests and clearance evaluation studies.
  • 10. Q5B: Quality of Biotechnological Products Q5C: Stability Testing of Biotechnological/Biological Products. Q5D: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products. The objective of this guideline is to provide broad guidance on appropriate standards for cell substrates. Q5E: Comparability of Biotechnological/ Biological Products Subject to Changes in Their Manufacturing Process The objective of this document is to provide principles for assessing the comparability of biotechnological/ biological products before and after changes are made in the manufacturing process for the drug substance or drug product. Therefore, this guideline is intended to assist in the collection of relevant technical information which serves as evidence that the manufacturing process changes will not have an adverse impact on the quality, safety and efficacy of the drug product.
  • 11. Q6: Specifications for New Drug Substances and Products Bulk drug substance and final product specifications are key parts of the core documentation for world-wide product license applications. This leads to conflicting standards for the same product, increased expenses and opportunities for error as well as a potential cause for interruption of product supply. Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products : Chemical Substances The main objective of this guideline is to establish a single set of global specifications for new drug substances and new drug products. A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria, which are numerical limits, ranges. This guideline addresses specifications, i.e., those tests, procedures, and acceptance criteria which play a major role in assuring the quality of the new drug substance and new drug product during shelf life.
  • 12. Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products This document provides guidance on justifying and setting specifications for proteins and polypeptides which are derived from recombinant or non-recombinant cell cultures. A valid biological assay to measure the biological activity should be provided by the manufacturer. Examples of procedures used to measure biological activity include: • Animal-based biological assays, which measure an organism's biological response to the product; • Cell culture-based biological assays, which measure biochemical or physiological response at the cellular level; • Biochemical assays, which measure biological activities such as enzymatic reaction rates or biological responses induced by immunological interactions. Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients The main objective of this guideline is that to maintain the quality of the active pharmaceutical ingredients.
  • 13. Q8(R2): Pharmaceutical Development This guideline is intended to provide guidance on the contents of Pharmaceutical Development of drug products. 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 Pharmaceutical Development section also describe the type of dosage form and the formulation that are suitable for the intended use. Q8 gives information about Drug Substance, Excipients, Container Closure System. Q9: Quality Risk Management The purpose of this document is to offer a systematic approach to quality risk management. This guideline provides principles and tools for 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 labeling materials.
  • 14. Q10: Pharmaceutical Quality System This document establishes a new ICH guideline describing a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. Comprehensive model for an effective pharmaceutical quality system is based on International Standards Organization (ISO) quality concepts, includes applicable Good Manufacturing Practice (GMP) regulations.