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 Quality Guidelines

 / Q1A - Q1F Stability
Code Document Title
 Q1A(R2)Stability Testing of New Drug Substances and ProductsQ1A
 Q1BStability Testing : Photostability Testing of New Drug Substances and Products
 Q1CStability Testing for New Dosage Forms
 Q1DBracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
 Q1EEvaluation of Stability Data
 Q1FStability Data Package for Registration Applications in Climatic Zones III and IV


 Q2 Analytical Validation
Code Document Title
 Q2(R2)/Q14Analytical Procedure Development and Revision of Q2(R1) Analytical Validation
 Q2(R1)Validation of Analytical Procedures: Text and Methodology

 Q3A - Q3D Impurities

Code Document Title
 Q3A(R2)Impurities in New Drug Substances
 Q3B(R2)Impurities in New Drug Products
 Q3C(R7)Impurities: Guideline for Residual Solvents Q3C, Q3C(M)
 Q3C(R8)Impurities: Guideline for Residual Solvents
 Q3D(R1)Guideline for Elemental Impurities
 Q3D(R2)Revision of Q3D(R1) for cutaneous and transdermal products
 Q3D trainingImplementation of Guideline for Elemental Impurities

 Q4 - Q4B Pharmacopoeias
ode Document Title
 Q4Pharmacopoeias
Description:
Q4A activity provided the framework on how to set specifications for drug substances to address how regulators and
manufacturers might avoid setting or agreeing to conflicting standards for the same product, as part of the registration in
different regions. The resulting ICH Q6A Guideline provides harmonised guidance in this area. With the passage of the
Chemical Substances (Q6A) ICH Guideline, the harmonisation of several compendial test chapters has been considered as
critical by the ICH Steering Committee. These chapters are at various stages of harmonisation among the three
pharmacopeial organisations (USP, JP & EP). The three organisations conduct their harmonisation efforts through a tripartite
pharmacopeial harmonisation program known as the Pharmacopoeial Discussion Group (PDG).
 Q4APharmacopoeial Harmonisation
 Q4BEvaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
 Q4B Annex 1R1Residue on Ignition/Sulphated Ash General Chapter
 Q4B Annex 2R1Test for Extractable Volume of Parenteral Preparations General Chapter
 Q4B Annex 3R1Test for Particulate Contamination: Sub-Visible Particles General Chapter
 Q4B Annex 4AR1Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General
Chapter
 Q4B Annex 4BR1Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms
General Chapter
 Q4B Annex 4CR1Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical
Preparations and Substances for Pharmaceutical Use General Chapter
 Q4B Annex 5R1Disintegration Test General Chapter
 Q4B Annex 6Uniformity of Dosage Units General Chapter
 Q4B Annex 7R2Dissolution Test General Chapter
 Q4B Annex 8R1Sterility Test General Chapter
 Q4B Annex 9R1Tablet Friability General Chapter
 Q4B Annex 10R1Polyacrylamide Gel Electrophoresis General Chapter
 Q4B Annex 11Capillary Electrophoresis General Chapter
 Q4B Annex 12Analytical Sieving General Chapter
 Q4B Annex 13Bulk Density and Tapped Density of Powders General Chapter
 Q4B Annex 14Bacterial Endotoxins Test General Chapter
 Q4B FAQsFrequently Asked Questions

 Q5A - Q5E Quality of Biotechnological Products

Code Document Title
 Q5A(R1)Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal
OriginQ5A
 Q5BAnalysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
 Q5CStability Testing of Biotechnological/Biological Products
 Q5DDerivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological
Products
 Q5EComparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing
Process

 Q6A- Q6B Specifications

Code Document Title
 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 Practice

Code Document Title
 Q7Good Manufacturing Practice Guide for Active Pharmaceutical IngredientsQ7A
 Q7 Q&AsQuestions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

 Q8 Pharmaceutical Development

Q8(R2)Pharmaceutical Development
 Q8/9/10 Q&AsR4Q8/Q9/Q10 - Implementation

 Q9 Quality Risk Management

Code Document Title
 Q9Quality Risk Management
 Q8/9/10 Q&AsR4Q8/Q9/Q10 - Implementation

 Q10 Pharmaceutical Quality System

Code Document Title
 Q10Pharmaceutical Quality System
 Q8/9/10 Q&AsR4Q8/Q9/Q10 - Implementation


  Q11 Development and Manufacture of Drug Substances

Q11Development and Manufacture of Drug Substances (Chemical Entities and
Biotechnological/Biological Entities)
 Q11 Q&AsQuestions & Answers: Selection and Justification of Starting Materials for the Manufacture
of Drug Substances

 Q12 Lifecycle Management

Code Document Title

 Q12Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

Draft Guideline: November 2017
Q12 draft Guideline

Q12 Annexes

Concept Paper

Business Plan

Work Plan

Experts list

Contribute to Q12

Rapporteur:

Dr. Ashley Boam (FDA, United States)

Regulatory Chair:

Ms. Nanna Aaby Kruse (EC, Europe)

Description:

This topic was endorsed by the ICH Steering Committee in September 2014.

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. It will allow regulators (assessors and inspectors) to better understand the firms
Pharmaceutical Quality Systems (PQSs) for management of post-approval CMC changes. This new guideline is
intended to complement the existing ICH Q8 to Q11 Guidelines, and includes a core Guideline as well as
Annexes.

Status:

Step 3
:

ANVISA, Brazil - Deadline for comments by 28 September 2018

CFDA, China- Deadline for comments by 18 December 2018
EC, Europe - Deadline for comments by 18 December 2018
FDA, United States - Deadline for comments by 15 December 2018
Health Canada, Canada - Deadline for comments by 26 August 2018
HSA, Singapore - Deadline for comments 26 October 2018
 MFDS, Republic of Korea - Deadline for comments by October 2018
MHLW/PMDA, Japan - Deadline for comments by 30 July 2018
Swissmedic, Switzerland - Refers to EC, Europe consultation
TFDA, Chinese Taipei - Deadline for comments by 26 November 2018

 Q13 Continuous Manufacturing of Drug Substances and Drug Products

ode Document Title
 Q13Continuous Manufacturing of Drug Substances and Drug Products
Rapporteur:
Dr. Sau Lee (FDA, United States)
Regulatory Chair:
Dr. Yoshihiro Matsuda (MHLW/PMDA, Japan)
Description:
This topic was endorsed by the Assembly in June 2018.
This new Guideline is proposed to:
• 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.
Status:
Step 1

Q14 Analytical Procedure Development

Q14Analytical Procedure Development

 Description:
 Work on the development of the Q14 Guideline on Analytical Procedure Development is performed by the
Q2(R2)/Q14 EWG. For further information, including the Concept Paper and Business Plan, please follow the
link here.

 Safety Guidelines
 /ICH Guidelines
 /Work Products
 /
ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and
reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation
liability: the single most important cause of drug withdrawals in recent years.

Stakeholders are invited to report Safety Guideline issues at [email protected].

 S1A - S1C Carcinogenicity Studies

 S2 Genotoxicity Studies

 S3A - S3B Toxicokinetics and Pharmacokinetics

 S4 Toxicity Testing

 S5 Reproductive Toxicology

 S6 Biotechnological Products

 S7A - S7B Pharmacology Studies

 S8 Immunotoxicology Studies

 S9 Nonclinical Evaluation for Anticancer Pharmaceuticals

 S10 Photosafety Evaluation

 S11 Nonclinical Paediatric Safety

 Efficacy Guidelines
 /ICH Guidelines
 /Work Products
 /
The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical
trials. It also covers novel types of medicines derived from biotechnological processes and the use of
pharmacogenetics/ pharmacogenomics techniques to produce better targeted medicines.

 E1 Clinical Safety for Drugs used in Long-Term Treatment

 E2A - E2F Pharmacovigilance

 E3 Clinical Study Reports

 E4 Dose-Response Studies

 E5 Ethnic Factors

 E6 Good Clinical Practice

 E7 Clinical Trials in Geriatric Population

 E8 General Considerations for Clinical Trials

 E9 Statistical Principles for Clinical Trials

 E10 Choice of Control Group in Clinical Trials

 E11 - E11A Clinical Trials in Pediatric Population

 E12 Clinical Evaluation by Therapeutic Category

 E14 Clinical Evaluation of QT

 E15 Definitions in Pharmacogenetics / Pharmacogenomics

 E16 Qualification of Genomic Biomarkers

 E17 Multi-Regional Clinical Trials

 E18 Genomic Sampling

 E19 Safety Data Collection

 Multidisciplinary Guidelines
 /ICH Guidelines
 /Work Products
 /
Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes
the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic
Standards for the Transfer of Regulatory Information (ESTRI).

 M1 MedDRA Terminology
 M2 Electronic Standards

 M3 Nonclinical Safety Studies

 M4 Common Technical Document

 M5 Data Elements and Standards for Drug Dictionaries

 M6 Gene Therapy

 M7 Mutagenic impurities

 M8 Electronic Common Technical Document (eCTD)

 M9 Biopharmaceutics Classification System-based Biowaivers

 M10 Bioanalytical Method Validation

 M11 Clinical electronic Structured Harmonised Protocol (CeSHarP)