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BY
HARISHANKAR SAHU
MBA PM07
IIHMR University, Jaipur
 The International Conference on Harmonisation of
Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH) is unique in
bringing together the regulatory authorities and
pharmaceutical industry to discuss scientific and
technical aspects of drug registration.
 ICH has gradually evolved, to respond to the
increasingly global face of drug development.
 Consists of Quality, Safety, Efficacy and
Multidisciplinary guidelines.
 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.
 Q1A-Q1F: Stability
Q1A(R2): Stability Testing of New Drug Substances and ProductsQ1A
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.
 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: Guideline for Residual SolventsQ3C,Q3C(M)
Q3D: Guideline for Elemental Impurities
Q3D: Implementation of Guideline for Elemental Impurities.
 Q4A-Q4B: Pharmacopeia
Q4APharmacopoeial Harmonisation
Q4BEvaluation and Recommendation of Pharmacopoeial Texts for Use 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 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.
 Q6A-Q6B: Specifications
Q6ASpecifications: Test Procedures and Acceptance Criteria for
New Drug Substances and New Drug Products: Chemical Substances
Q6BSpecifications: 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 (medicinal) products, biological and
biotechnological products, including the use of raw materials, solvents,
excipients, packaging and labelling materials.
 Q10: Pharmaceutical Quality System
This Guideline applies to pharmaceutical drug substances and drug
products, including biotechnology and biological products, throughout the
product lifecycle.
 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.
 Q12: Lifecycle Management
 This new guideline 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
Guideline will promote innovation and continual improvement, and strengthen
quality assurance and reliable supply of product, including proactive planning
of supply chain adjustments.
 ICH Quality guidelines serves as important
tool for the quality of the products across the
globe.
 http://www.ich.org/products/guidelines/quality/article
/quality-guidelines.
THANK YOU

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Ich – quality guidelines

  • 2.  The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration.  ICH has gradually evolved, to respond to the increasingly global face of drug development.  Consists of Quality, Safety, Efficacy and Multidisciplinary guidelines.
  • 3.  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.
  • 4.  Q1A-Q1F: Stability Q1A(R2): Stability Testing of New Drug Substances and ProductsQ1A 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.  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: Guideline for Residual SolventsQ3C,Q3C(M) Q3D: Guideline for Elemental Impurities Q3D: Implementation of Guideline for Elemental Impurities.
  • 5.  Q4A-Q4B: Pharmacopeia Q4APharmacopoeial Harmonisation Q4BEvaluation and Recommendation of Pharmacopoeial Texts for Use 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 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.  Q6A-Q6B: Specifications Q6ASpecifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances Q6BSpecifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products.
  • 6.  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 (medicinal) products, biological and biotechnological products, including the use of raw materials, solvents, excipients, packaging and labelling materials.
  • 7.  Q10: Pharmaceutical Quality System This Guideline applies to pharmaceutical drug substances and drug products, including biotechnology and biological products, throughout the product lifecycle.  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.  Q12: Lifecycle Management  This new guideline 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 Guideline will promote innovation and continual improvement, and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments.
  • 8.  ICH Quality guidelines serves as important tool for the quality of the products across the globe.