ICH Guidelines- Quality
What Is mean by ICH Guidelines ?
The International Council for Harmonisation has created a set of guidelines known as the ICH guidelines for the pharmaceutical industry. ICH is a global organization that brings together regulatory authorities and the pharmaceutical industry to develop consensus-based guidelines for the development, registration, and post-approval of pharmaceutical products.
The ICH guidelines provide recommendations and standards for various aspects of drug development, including Quality, Safety, Efficacy, and Multidisciplinary Topics. These guidelines help to harmonize regulatory requirements and facilitate the global registration and approval of pharmaceutical products.
The International Council for Harmonisation (ICH), previously it was called as International Conference on Harmonisation (ICH).
ICH Full Form: International Council for Harmonisation.
Founding Regulatory: EC- Europe; MHLW/PMDA-Japan; FDA-United States
Summary/List of ICH Guidelines (International Council of Harmonisation) :- Quality
ICH Q1A to Q1F- Stability
ICH Q1A (R2) : Stability Testing of New Drug Substances and Products
This ICH Guideline provides recommendations on stability testing protocols including temperature, humidity and trial duration for Climatic Zone I, II,II and IV in order to minimize the different storage conditions for submission of a global dossier.
ICH Q1B : Stability Testing : Photostability Testing of New Drug Substances and Products
This ICH Guideline is an addition to the stability Guideline, and provides guidance on basic testing protocol required for evaluation of light sensitivity and stability of new drugs and products.
ICH Q1C : Stability Testing for New Dosage Forms
This ICH Guideline Provide information about stability Guideline for new formulations of already approved medicines and defines at which circumstances reduced stability data can be accepted.
ICH Q1D : Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Products
This ICH Guideline provide recommendations on the application of bracketing and matrixing to stability studies conducted in accordance with principles outlined in the main stability Guideline.
ICH Q1E : Evaluation of stability data
This ICH Guideline explains possible situations where extrapolation of retest periods or shelf-life beyond the real-time data may be appropriate. In addition to that it provides examples of statistical approaches to stability data analysis.
ICH Q1 F : Stability data package for registration applications in Climatic zones III and IV
This ICH Guideline defined storage conditions for stability testing in countries located in Climatic Zones III (hot and dry) and IV (hot and humid).
ICH Q2 : Analytical Validations
ICH Q2(R1) : Validation of Analytical Procedures : Text and Methodology
This ICH Guideline provides guidance on analytical method validation to ensure accuracy, precision, specificity, and robustness. The guidelines aim to promote global harmonization in drug development and manufacturing processes.
ICH Q3A to Q3E : Impurities
ICH Q3A (R2) : Impurities of New Drug Substances
This ICH Guideline Defines safety aspects of impurities, including the listing of impurities in specifications and describes thresholds, for reporting , identification and qualification as well for drug substances.
ICH Q3B (R2) : Impurities in New Drug Products
This ICH guidelines state that summarization of acceptable limits and evaluation methods for impurities in new drug substances and products. It provides guidance on how to identify and quantify impurities, and how to determine their potential risk to human health. The document is intended to ensure the safety and quality of pharmaceuticals for human use.
In addition to above this Guideline specifically deals with those impurities which might arise as degradation products of the drug substance, or arising from interactions between drug substance and excipients or components of primary packaging materials.
ICH Q3C (R8) : Guideline for Residual solvent
This ICH Guideline providing recommendations on usages of less toxic solvents in the manufacturing of drug substances and Drug products (Dosage forms) and setting pharmaceutical limits for residual solvents in drug products.
ICH Q3D (R2) : Guideline for elemental Impurities
This ICH Guideline Gives information about control of elemental impurities in new drug products (Pharmaceutical products), and it set up Permitted Daily Exposures (PDEs) for drug products which are administered by oral, parenteral and inhalation routes of administration. Moreover, guidance is provided on how to develop an acceptable level for elemental impurities for drug products administered by other routes of administration.
ICH Q3E EWG : Impurity : Assessment and control of extractables and leachable for pharmaceuticals and biologics
This ICH Guideline was established to work on the development on the assessment and control of extractables and leachable for pharmaceuticals and biologics.
ICH Q4A- Q4B : Pharmacopoeia
ICH Q4A : Pharmacopeial Harmonisation
This guidance provide outset and harmonisation between the major pharmacopoeias.
ICH Q4B : Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
ICH Q4B describes a process for the evaluation and recommendation of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions.
ICH Q4B Annexure 1 (R1) : Residue on Ignition/Sulphated ash General Chapter
Provide information on Residue on Ignition/Sulphated Ash General Chapter.
ICH Q4B Annexure 2 (R1) : Test for extractable volume of parenteral preparations General Chapter
Gives information about Test for Extractable Volume of Parenteral Preparations General Chapter.
ICH Q4B Annexure 3 (R1) : Test of Particulate Contamination: Sub visible particles General Chapter
Gives information on Test of Particulate Contamination: Sub visible particles General Chapter.
ICH Q4B Annexure 4A (R1) : Microbial examination of non sterile products : Microbial Enumeration Tests General Chapter
Provide information on Microbial examination of non-sterile products : Microbial Enumeration Tests General Chapter.
ICH Q4B Annex 4B (R1) : Microbial examination of non-sterile products : Tests for specified microorganism general Chapter
Gives detailing on Microbial examination of non-sterile products : Tests for specified microorganism general Chapter.
ICH Q4B Annex 4C (R1) : Microbial examination of non-sterile products : Acceptance Criteria for pharmaceutical preparations and substances for pharmaceutical use General Chapter
Gives information about microbial examination of non-sterile products Acceptance Criteria for pharmaceutical preparations and substances for pharmaceutical use General Chapter.
ICH Q4B Annex 5 (R1) : Disintegration Test General Chapter
Provide Guidance on Disintegration Test General Chapter.
ICH Q4B Annex 6 : Uniformity of dosage units general Chapter
Provide information about Uniformity of dosage units general Chapter.
ICH Q4B Annex 7 (R2) : Dissolution Test General Chapter
Annexure 7 (R2) Provide information on Uniformity of dosage units general Chapter.
ICH Q4B Annex 8 (R1) : Sterility Test General Chapter
Gives information about Sterility Test General Chapter.
ICH Q4B Annex 9 (R1) : Tablet Friability General Chapter
This Document provide information on Tablet Friability General Chapter.
ICH Q4B Annex 10 (R1) : Polyacrylamide Gel electrophoresis General chapter
Gives information about Polyacrylamide Gel electrophoresis General chapter.
ICH Q4B Annex 11 : Capillary Electrophoresis General Chapter
Provide information on Capillary Electrophoresis General Chapter.
ICH Q4B Annex 12 : Analytical Sieving General Chapter
Provide Guidance on Analytical sieving General Chapter.
ICH Q4B Annex 13 : Bulk density and Tap density of powders General Chapter
Gives information about Bulk density and Tap density of powders General Chapter.
ICH Q4B Annex 14 : Bacterial Endotoxins Test General chapter
This ICH Guideline provide information on Bacterial Endotoxins Test General chapter.
ICH Q5A to Q5 E : Quality of Biotechnological Products
ICH Q5A (R1) : Viral safety Evaluation of biotechnology products derived from cell lines of human or animal origin
This ICH Guideline is concerned with testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal origin and outlines data that should be submitted in the marketing application/registration purposes. Moreover this Guideline will provide a general framework for virus testing, experiments for the assessment of viral clearance and a recommended approach for the design of viral tests and viral clearance studies.
ICH Q5 (B) : Analysis of Expression Construct in cells used for production of r-DNA Derived protein Products
This ICH Guideline provides Guidance about types of information that are considered valuable in assessing the structure of the expression construct used to produce recombinant DNA derived proteins.
ICH Q5C : Quality of Biotechnological products : Stability testing of biotechnological /Biological Products
This ICH Guideline provides information about particular aspects of stability test procedures needed to take account of the special characteristics of products in which the active components are typically proteins and polypeptides.
ICH Q5D : Derivation and Characterisation of cell substrates used for production of biotechnological/Biological Products
This document gives information about appropriate standards for the derivation of human and animal cell lines and microbial cells used to prepare biotechnological/biological products, and for the preparation and characterisation of cell banks to be used for production.
ICH Q5E : Comparability of biotechnological/Biological products Subject to changes in their manufacturing process
This Guide explains about 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.
ICH Q6A-Q6B : Specification
ICH Q6A : Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products : Chemical Substances
This ICH Guideline provides guidance on setting and justification of acceptance criteria and selection of test procedures for new drug substances of synthetic chemical origin, and new drug products.
ICH Q6B : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
This ICH Guideline provides guiding principles on the setting and justification of a uniform set of international specifications for proteins and polypeptides which are produced from recombinant or non-recombinant cell-culture expression systems.
ICH Q7 : Good Manufacturing Practices
ICH Q7A : Good Manufacturing practice guide for Active Pharmaceutical Ingredient
This document provide guidance on Good Manufacturing Practice (GMP) for the manufacturing of Active Pharmaceutical Ingredients (APIs) with considering appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements for quality and purity.
ICH Q8 : Pharmaceutical Development
ICH Q8 (R2) : Pharmaceutical Development
This ICH Guideline provide guidance on Pharmaceutical Development for drug products.
ICH Q9: Quality Risk Management
ICH Q9 (R1) : Quality Risk management
This ICH Guideline describes on the principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality and make limited and specific adjustments to specific chapters and annexes of the current ICH Q9 on Quality Risk Management (QRM).
ICH Q10 : Pharmaceutical Quality System
This ICH Guideline applies to the systems supporting the development and manufacture of pharmaceutical drug substances and drug products, including biotechnology and biological products.
ICH Q11 :Development and Manufacture of drug substances
ICH Q11 : Development and Manufacture of drug substances ( Chemical entities and biotechnological /Biological entities)
This document applies to the systems supporting the development and manufacture of pharmaceutical drug substances and drug products, including biotechnology and biological products.
ICH Q12 : Lifecycle Management
ICH Q12 : Technical and Regulatory Considerations for pharmaceutical products lifecycle management
This Guide 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.
ICH Q13 : Continuous Manufacturing of drug substances and drug Products
The guideline figured out on existing ICH Quality Guidelines, provides clarification on continuous manufacturing (CM) concepts, moreover it describes scientific approaches, and presents regulatory considerations specific to Continuous manufacturing (CM) of drug substances and drug products. In addition to that it emphases on the integrated aspects of a Continuous manufacturing (CM) system in which two or more unit operations are directly connected.
It Describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of CM.
ICH Q14 : Analytical Procedure development
ICH Q2 (R2)/Q14 EWG : Analytical procedure development and revision of Q2 (R1) analytical validation
This Documents describes on Analytical Procedure Development, and revise the ICH Q2(R1) Guideline on Validation of Analytical Procedures, with a view to potentially combine both documents, for simplification and clarity.
For Detailed Description and download of PDF For ICH Quality Guidelines Plz click on below link.
https://www.ich.org/page/quality-guidelines
