ICH Guidelines

PRSENTED BY : MANISH SHANKARPURE

M.PHARM ( QUALITY ASSURANCES AND TECHNIQUES )
INTRODUCTION

The International Conference on Harmonisation of

Technical Requirements for Registration of
Pharmaceuticals for 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.
AIM
ICH was established in 1990 as a joint regulatory/industry
project to improve, through harmonisation, the efficiency of
the process for developing and registering new medicinal
products in Europe, Japan and the United States, in order to
make these products available to patients with a minimum of
delay.
The six parties to ICH represent the regulatory bodies and
research based industry in the three regions, Europe, Japan
and the USA, where the vast majority of new medicines are
currently developed.
OBJECTIVE

 More economical use of human, animal, and material resources.

 Elimination of unnecessary delay in the global development &
availability of new medicines.
 Maintaining safeguards on Quality, safety, efficacy and regulatory
obligations to protect public health.
ICH PARTIES
 European Commission - European Union (EU).
 European Federation of Pharmaceutical Industries and Associations (EFPIA).
 Ministry of Health, Labour and Welfare, Japan (MHLW).
 Japan Pharmaceutical Manufacturers Association (JPMA).
 US Food and Drug Administration (FDA).
 Pharmaceutical Research and Manufacturers of America (PhRMA).
ICH PRODUCTS
 ICH has developed harmonised Guidelines aimed at eliminating duplication in the development
and registration process, so that a single set of studies can be generated to demonstrate the
quality, safety and efficacy of a new medicinal product.
 Quality-14 Guidelines
 Safety -14 Guidelines
 Efficacy -20 Guidelines
 Multidisciplinary -5 Guidelines
 Electronic Standards for the Transfer of Regulatory Information (ESTRI, E2B)
 Common Technical Document (CTD & eCTD)
 Medical dictionary for adverse event reporting and coding of clinical trial data (MedDRA)
ICH GUIDELINES

The ICH Topics are divided into four major categories and ICH Topic Codes are assigned
according to these categories.
Q S E M

"Quality" Topics, "Safety" Topics, i.e., “Efficacy" Topics, "Multidisciplinary"

i.e., those relating those relating to in i.e., those relating Topics, i.e.,
to chemical and vitro and in vivo to clinical studies in crosscutting Topics
pharmaceutical pre-clinical studies human subject which do not fit
Quality Assurance (Carcinogenicity (Dose Response uniquely into one
(Stability Testing, Testing, Studies, Good of the above
Impurity Testing, Genotoxicity Clinical Practices, categories
etc.) Testing, etc.) etc.) (MedDRA, ESTRI,
M3, CTD, M5)
QUALITY 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, Q13 & Q14.
 Q1A-Q1F: Stability
Q1A(R2): Stability Testing of New Drug Substances and Products
Q1A 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 Product
 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.
Figure 1 : Quality risk management
 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.
 Q13: Continous manufacturing of drug substances and drug products

• Capture key technical and regulatory considerations that promote

harmonisation, including certain Current Good Manufacturing Practices
(CGMP) elements specific to Continuous Manufacturing (CM)
• Allow drug manufacturers to employ flexible approaches to develop,
implement, or integrate CM for the manufacture – drug substances and drug
products – of small molecules and therapeutic proteins for new and existing
products,
• 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.
 Q 14 Analytical 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.
• Quality risk manegment
Conclusion

 ICH brings together the drug regulatory authorities of Europe,

Japan, and the United States, along with the pharmaceutical
trade associations from these three regions, to discuss scientific
and technical aspects of product registration.
 It is ICH’s mission to achieve greater harmonization in the
interpretation and application of technical guidelines and
requirements for product registration, thereby reducing
duplication of testing and reporting carried out during the
research and development of new medicines.
Thank you