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The International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for the Human use
(ICH) is a unique project that brings together the regulatory authorities
of Europe, Japan and the United States and experts from the
pharmaceutical industry in the three regions to discuss scientific and
technical aspects of product registration.
o European Commission – European Union (EU).
o European Federation of Pharmaceutical Industries and Associations
(EFPIA).
o Ministry of Health, Labour and Welfare, Japan (MHLW).
o Japan Pharmaceutical Manufactures Association (JPMA).
o US Food and Drug Administration (FDA).
o Pharmaceutical Research and Manufactures of America (PhRMA).
 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 effective and cost-
effective manner.
 To promote public health.
 To prevent unnecessary duplication of clinical trails on humans.
 To minimize the use of animal testing without compromising safety and
effectiveness of drug.
• Four Broad Categories – QSEM.
• Quality (Q): those relating to chemicals and pharmaceutical Quality
Assurance (Stability Testing, Impurity Testing, etc).
• Safety (S): those relating to in vitro and in vivo pre-clinical studies
(Carcinogenicity Testing, Genotoxicity Testing, etc).
• Efficacy (E): those relating to clinical studies in the human
subject (Dose Response Studies, Good Clinical Practices, etc).
• Multidisciplinary (M): cross-cutting Topics which do not fit
uniquely into one of the above categories (MedDRA, ESTRI,
M3, CTD, M5).
1. The ICH Steering Committee is responsible for the governance of ICH.
This includes deciding on the adoption of every ICH project, whether a
new topic, maintenance of an existing Guideline, or a specific
implementation work.
2. Each harmonization activity is initiated by a Concept Paper which is a
short summary of the proposal. Depending on the category of
harmonization activity a Business Plan may also be required.
3. Any ICH Party or Observer is welcomed to submit a proposal for a new
ICH activity.
4. The ICH Steering Committee decides on the adoption of every ICH
project and then endorses the creation of an EWG/IWG.
5. ICH harmonization activities fall into 4 categories: Formal ICH
Procedure, Q&A Procedure, Revision Procedure and Maintenance
Procedure.
• CONSENSUS BULDING:
- Rapporteur prepares initial draft of a guidelines/recommendation for comment with
fixed deadlines for comment(fax, e-mail). Interim report made to SC meeting, if consensus
is reached, sign-off – all members.
• START OF REGULATING ACTION.
• WIDE RANGING REGULATORY CONSULATION:
- EU: published as a draft CPMP guidelines; US: published as a draft guidance in the
Federal Register; Japan: translate & issued by MHLW for internal and external
consultation. A Regulatory Rapporteur is dessignated to draw up the final document and
sign off.
• ADOPTION OF A TRIPARTITE HARMONISED TEXT:
- Both regulatory and industry parties of SC must be satisfied. Adoption takes place on
the signatures from the 3 regulatory parties to ICH, affirming that the guidelines is
recommended for adoption by the 3 regulatory bodies.
• IMPLEMENTATION.
 Quality (Q1-Q11):
- Chemical & Pharmaceutical QA.
 Safety (S1-S10, M3):
- Dealing with in-vitro & in-vivo preclinical testing.
 Efficacy (E1-E16 Except E13):
- Clinical study in human beings.
 Multidisciplinary (M1-M8):
- Terminology, electronic standards, common documents.
1. Q1:- Stability.
2. Q2:- Analytical Validation.
3. Q3:- Impurities.
4. Q4:- Pharmacopoeias.
5. Q5:- Quality of Biotechnological Products.
6. Q6:- Specification.
7. Q7:- Good Manufacturing Practice.
8. Q8:- Pharmaceutical Development.
9. Q9:- Quality risk management.
10. Q10:- Pharmaceutical Quality System.
11. Q11:- Development and Manufacturing Drug Substances.
 S1:- Carcinogenicity Studies.
 S2:- Geno-toxicity Studies.
 S3:- Toxico-kinetics and Pharmacokinetics.
 S4:- Toxicity Testing.
 S5:- Reproductive toxicology.
 S6:- Biotechnology Product.
 S7:- Pharmacology Studies.
 S8:- Immuno-toxicology Studies.
 S9:- Nonclinical evaluation for anticancer Pharmaceutical.
 S10:- Photosafety Evaluation.
EFFICACY:
 E1&E2:- Clinical Safety.
 E3:- Clinical Study Reports.
 E4:- Dose-response Studies.
 E5:- Ethnic Factors.
 E6:- Good Clinical Practice.
 E7, E8, E9, E10, E11:- Clinical Trials.
 E12:- Guidelines for Clinical Evaluation by therapeutic category.
 E14:- Clinical Evaluation.
 E15&E16:- Pharmacogenomics.
 M1- MedDRA Terminology.
 M2 – Electronic Standards.
 M3 – Non-Clinical Safety Studies.
 M4 – CTD.
 M5 – Data elements & Standards for Drug dictionaries.
 M6 – Gene Therapy.
 M7 – Genotoxic impurities.
 M8 – eCTD.
 Harmonization 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.
 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 Application in Climatic Zones III & IV.
 Q2: Analytical Validation:
- Validation of Analytical Procedures: Methodology.
 Q3A-Q3D: Impurities:
- Q3A(R2): Impurities in New Drug Substances.
- Q3B(R2): Impurities in New Drug Products.
- Q3C(R5): Impurities: Guidelines for Residual SolventsQ3C, Q3C(M).
- Q3D: Guidelines for Elemental Impurities.
- Q3D: Implementation of Guideline for Elemental Impurities.
 Q4A-Q4B: Pharmacopeia
- Q4A Pharmacopeial Harmonization.
- Q4B: Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions.
 Q5A-Q5E: Quality of Biotechnology Products
- Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or
Animal Origin.
- 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.
 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.
 Q7: Good Manufacturing Practices
- In February 1998, the ICH Steering Committee agreed that GMP for Active
Pharmaceutical Ingredients (APIs) should be adopted as an ICH topic.
 Q8: Pharmaceutical Development
- 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.
 Q9: Quality Risk Management
- 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 (medical) products, biological and
biotechnological products, including the use of raw materials, solvents, excipients,
packaging and labelling materials.
 Q10:Pharmaceutical Quality System
- This Guidelines applies to pharmaceutical drug substances and drug products, including
biotechnology and biological products, throughout the product life cycle.
 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. – 2.6) of Drug Substances
including both chemical entities and biotechnological/biological entities.
 Q12: Lifecycle Management
- This new guidelines is proposed to provide guidance on 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 Guidelines will promote innovation and continual improvement, and strengthen quality
assurance and reliable supply of product, including proactive planning of supply chain
adjustments.
ICH GUIDELINES FOR STABILITY TESTING
• 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 application in Climatic Zones III & IV.
• Q5C – Stability testing of biotechnological/biological products.
 OBJECTIVE OF THE GUIDELINES:
- It defines stability of drug substances and drug product for registration of
application of NCE or associated drug, within three regions of ICH i.e., EU,
Japan, USA.
NOTE: It does not cover testing for registration of drug substances or products
intended for import or export to other areas of the world.
- Light can affect drugs, causing chemical changes so…
1. To Evaluate that light exposure does not result in unacceptable
change.
2. Provides means of screening drug early in the development
process & allows identification of particular photo labile drug.
3. Gives idea about how to store drug.
4. For generation of photostability information for submission in
Registration Applications for new molecular entities and associated
drug products.
 DEFINITION:
- A new dosage form is defined as a medicinal product which is a different
pharmaceutical product type, but containing the same active substances as included in
an existing product approved by the pertinent regulatory authority.
 INCLUDE:
- Products of a different route of administration (e.g., oral to parenteral), new specific
functionally/delivery systems (e.g., immediate release tablet to modified release tablet)
and different dosage forms of the same route of administration (e.g., capsule to tablet,
solution to suspension).
1. Stability protocols for the new dosage forms should follow the guidance in the parent
stability guideline in principle. However, a reduced stability database at submission time
be acceptable with proper justification.
2. E.g., 6 months accelerated and 6 months long term data from ongoing studies may be
acceptable in certain justified cases.
• Outlines recommendations, principles, and considerations for reduced
designs.
- Terms:
• Full Study Design: Samples for every combination of all design factors
are tested at all time points.
• Reduced Study Design: Not all samples for every factor combination
are tested at all time points. Ex: bracketing, matrixing.
It describes:
• How to propose a retest period for drug substances and a shelf life
for drug products in the registration application.
• When and how a extrapolation beyond available data can be
considered.
• EXTRAPOLATION: Extrapolation is the practice of using a known
data set to infer the information about a future data.
 Climatic conditions in the countries where the product is to be marketed
should be carefully considered during the development phase. So the
world has been divided into four climatic zones based on the prevalent
annual climatic conditions.
 Temperature and humidity determine the storage conditions and so they
greatly affect the stability of the product.
 ICH Quality guidelines serves as important tool for the quality
of the products across the globe.
Ich

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Ich

  • 1.
  • 2. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for the Human use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.
  • 3. o European Commission – European Union (EU). o European Federation of Pharmaceutical Industries and Associations (EFPIA). o Ministry of Health, Labour and Welfare, Japan (MHLW). o Japan Pharmaceutical Manufactures Association (JPMA). o US Food and Drug Administration (FDA). o Pharmaceutical Research and Manufactures of America (PhRMA).
  • 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 effective and cost- effective manner.  To promote public health.  To prevent unnecessary duplication of clinical trails on humans.  To minimize the use of animal testing without compromising safety and effectiveness of drug.
  • 5. • Four Broad Categories – QSEM. • Quality (Q): those relating to chemicals and pharmaceutical Quality Assurance (Stability Testing, Impurity Testing, etc). • Safety (S): those relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc).
  • 6. • Efficacy (E): those relating to clinical studies in the human subject (Dose Response Studies, Good Clinical Practices, etc). • Multidisciplinary (M): cross-cutting Topics which do not fit uniquely into one of the above categories (MedDRA, ESTRI, M3, CTD, M5).
  • 7. 1. The ICH Steering Committee is responsible for the governance of ICH. This includes deciding on the adoption of every ICH project, whether a new topic, maintenance of an existing Guideline, or a specific implementation work. 2. Each harmonization activity is initiated by a Concept Paper which is a short summary of the proposal. Depending on the category of harmonization activity a Business Plan may also be required. 3. Any ICH Party or Observer is welcomed to submit a proposal for a new ICH activity. 4. The ICH Steering Committee decides on the adoption of every ICH project and then endorses the creation of an EWG/IWG. 5. ICH harmonization activities fall into 4 categories: Formal ICH Procedure, Q&A Procedure, Revision Procedure and Maintenance Procedure.
  • 8.
  • 9.
  • 10. • CONSENSUS BULDING: - Rapporteur prepares initial draft of a guidelines/recommendation for comment with fixed deadlines for comment(fax, e-mail). Interim report made to SC meeting, if consensus is reached, sign-off – all members. • START OF REGULATING ACTION. • WIDE RANGING REGULATORY CONSULATION: - EU: published as a draft CPMP guidelines; US: published as a draft guidance in the Federal Register; Japan: translate & issued by MHLW for internal and external consultation. A Regulatory Rapporteur is dessignated to draw up the final document and sign off. • ADOPTION OF A TRIPARTITE HARMONISED TEXT: - Both regulatory and industry parties of SC must be satisfied. Adoption takes place on the signatures from the 3 regulatory parties to ICH, affirming that the guidelines is recommended for adoption by the 3 regulatory bodies. • IMPLEMENTATION.
  • 11.  Quality (Q1-Q11): - Chemical & Pharmaceutical QA.  Safety (S1-S10, M3): - Dealing with in-vitro & in-vivo preclinical testing.  Efficacy (E1-E16 Except E13): - Clinical study in human beings.  Multidisciplinary (M1-M8): - Terminology, electronic standards, common documents.
  • 12. 1. Q1:- Stability. 2. Q2:- Analytical Validation. 3. Q3:- Impurities. 4. Q4:- Pharmacopoeias. 5. Q5:- Quality of Biotechnological Products. 6. Q6:- Specification. 7. Q7:- Good Manufacturing Practice. 8. Q8:- Pharmaceutical Development. 9. Q9:- Quality risk management. 10. Q10:- Pharmaceutical Quality System. 11. Q11:- Development and Manufacturing Drug Substances.
  • 13.  S1:- Carcinogenicity Studies.  S2:- Geno-toxicity Studies.  S3:- Toxico-kinetics and Pharmacokinetics.  S4:- Toxicity Testing.  S5:- Reproductive toxicology.  S6:- Biotechnology Product.  S7:- Pharmacology Studies.  S8:- Immuno-toxicology Studies.  S9:- Nonclinical evaluation for anticancer Pharmaceutical.  S10:- Photosafety Evaluation.
  • 14. EFFICACY:  E1&E2:- Clinical Safety.  E3:- Clinical Study Reports.  E4:- Dose-response Studies.  E5:- Ethnic Factors.  E6:- Good Clinical Practice.  E7, E8, E9, E10, E11:- Clinical Trials.  E12:- Guidelines for Clinical Evaluation by therapeutic category.  E14:- Clinical Evaluation.  E15&E16:- Pharmacogenomics.
  • 15.  M1- MedDRA Terminology.  M2 – Electronic Standards.  M3 – Non-Clinical Safety Studies.  M4 – CTD.  M5 – Data elements & Standards for Drug dictionaries.  M6 – Gene Therapy.  M7 – Genotoxic impurities.  M8 – eCTD.
  • 16.  Harmonization 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.
  • 17.  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 Application in Climatic Zones III & IV.  Q2: Analytical Validation: - Validation of Analytical Procedures: Methodology.  Q3A-Q3D: Impurities: - Q3A(R2): Impurities in New Drug Substances. - Q3B(R2): Impurities in New Drug Products. - Q3C(R5): Impurities: Guidelines for Residual SolventsQ3C, Q3C(M). - Q3D: Guidelines for Elemental Impurities. - Q3D: Implementation of Guideline for Elemental Impurities.
  • 18.  Q4A-Q4B: Pharmacopeia - Q4A Pharmacopeial Harmonization. - Q4B: Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions.  Q5A-Q5E: Quality of Biotechnology Products - Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. - 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.
  • 19.  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.  Q7: Good Manufacturing Practices - In February 1998, the ICH Steering Committee agreed that GMP for Active Pharmaceutical Ingredients (APIs) should be adopted as an ICH topic.  Q8: Pharmaceutical Development - 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.
  • 20.  Q9: Quality Risk Management - 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 (medical) products, biological and biotechnological products, including the use of raw materials, solvents, excipients, packaging and labelling materials.  Q10:Pharmaceutical Quality System - This Guidelines applies to pharmaceutical drug substances and drug products, including biotechnology and biological products, throughout the product life cycle.
  • 21.  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. – 2.6) of Drug Substances including both chemical entities and biotechnological/biological entities.  Q12: Lifecycle Management - This new guidelines is proposed to provide guidance on 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 Guidelines will promote innovation and continual improvement, and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments.
  • 22. ICH GUIDELINES FOR STABILITY TESTING • 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 application in Climatic Zones III & IV. • Q5C – Stability testing of biotechnological/biological products.
  • 23.  OBJECTIVE OF THE GUIDELINES: - It defines stability of drug substances and drug product for registration of application of NCE or associated drug, within three regions of ICH i.e., EU, Japan, USA. NOTE: It does not cover testing for registration of drug substances or products intended for import or export to other areas of the world.
  • 24. - Light can affect drugs, causing chemical changes so… 1. To Evaluate that light exposure does not result in unacceptable change. 2. Provides means of screening drug early in the development process & allows identification of particular photo labile drug. 3. Gives idea about how to store drug. 4. For generation of photostability information for submission in Registration Applications for new molecular entities and associated drug products.
  • 25.  DEFINITION: - A new dosage form is defined as a medicinal product which is a different pharmaceutical product type, but containing the same active substances as included in an existing product approved by the pertinent regulatory authority.  INCLUDE: - Products of a different route of administration (e.g., oral to parenteral), new specific functionally/delivery systems (e.g., immediate release tablet to modified release tablet) and different dosage forms of the same route of administration (e.g., capsule to tablet, solution to suspension). 1. Stability protocols for the new dosage forms should follow the guidance in the parent stability guideline in principle. However, a reduced stability database at submission time be acceptable with proper justification. 2. E.g., 6 months accelerated and 6 months long term data from ongoing studies may be acceptable in certain justified cases.
  • 26. • Outlines recommendations, principles, and considerations for reduced designs. - Terms: • Full Study Design: Samples for every combination of all design factors are tested at all time points. • Reduced Study Design: Not all samples for every factor combination are tested at all time points. Ex: bracketing, matrixing.
  • 27. It describes: • How to propose a retest period for drug substances and a shelf life for drug products in the registration application. • When and how a extrapolation beyond available data can be considered. • EXTRAPOLATION: Extrapolation is the practice of using a known data set to infer the information about a future data.
  • 28.  Climatic conditions in the countries where the product is to be marketed should be carefully considered during the development phase. So the world has been divided into four climatic zones based on the prevalent annual climatic conditions.  Temperature and humidity determine the storage conditions and so they greatly affect the stability of the product.
  • 29.  ICH Quality guidelines serves as important tool for the quality of the products across the globe.