What are the 3 main types of ICH guidance documents?

ICH Guidance Documents
  • ICH E5: Ethnic Factors in the Acceptability of Foreign Clinical Data (PDF - 89KB)
  • ICH E6: Good Clinical Practice: Consolidated Guidance (R2- Integrated Addendum) (PDF - 484 KB)
  • ICH E10: Choice of Control Group and Related Issues in Clinical Trials (PDF - 93KB)


What are the different ICH guidelines?

The ICH topics are divided into the four categories below and ICH topic codes are assigned according to these categories.
  • Quality Guidelines. ...
  • Safety Guidelines. ...
  • Efficacy Guidelines. ...
  • Multidisciplinary Guidelines.


What are the 3 ICH regions?

ICH was established through cooperation of the regulatory agencies and industrial parties of three main regions involved in pharmaceuticals: the European Union, the United States, and Japan.


What is ICH q3 guidelines?

This document provides guidance on the content and qualification of impurities in new drug substances for registration applications. It applies to drug substances produced by chemical syntheses and not previously registered in a region or Member State.

What are the ICH GCP guidelines?

First produced in June 1996, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) is an internationally agreed standard that ensures ethical and scientific quality in designing, recording and reporting trials that ...


Basics - Part 22 - Essential Documents



What are the ICH q1 guidelines?

The standard conditions for photostability testing are described in ICH Q1B. Data from stability studies should be provided on at least three primary batches of the drug product. The primary batches should be of the same formulation and packaged in the same container closure system as proposed for marketing.

What are the four categories of ICH?

The ICH Guidelines are divided into four major categories and ICH Topic Codes are assigned according to these categories.
  • "Quality" Topics.
  • "Safety" Topics.
  • "Efficacy" Topics.
  • "Multidisciplinary" Topics.


What is ICH Q4 guidelines?

ICH Q4 is split into Q4A (Pharmacopoeial Harmonization) and Q4B (Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions). ICH Q4 and Q4B are often used interchangeably and this is the case in this chapter. The objective of harmonization is to develop interchangeable methods or requirements.


What are ICH q2 guidelines?

This guideline applies to new or revised analytical procedures used for release and stability testing of commercial drug substances and products (chemical and biological/biotechnological).

What is ICH Q7 guidelines?

The ICH guidance Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality.

What is the main purpose of ICH guidelines?

ICH aims to achieve greater harmonisation worldwide for the development and approval of safe, effective, and high-quality medicines in the most resource-efficient manner.


What is FDA and ICH guidelines?

This International Conference on Harmonization (ICH) document makes recommendations on information that should be included in a core clinical study report of an individual study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects.

How many principles are there in ICH?

There are 13 core principles of ICH-GCP and they are as follows: 1. Clinical trials should be conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).

How many types of guidelines are there in pharma?

This web page links to all current WHO norms and standards for pharmaceuticals guidelines which are grouped into (1) development, (2) production, (3) distribution, (4) inspection, (5) quality control, (6) regulatory standards and (7) specific texts for prequalification of medicines.


What is ICH e6 guideline?

This document addresses the good clinical practice, an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.

Which of the following categories are ICH guidelines grouped into?

The ICH topics are divided into four categories and ICH topic codes are assigned according to these categories: Q: Quality Guidelines. S: Safety Guidelines. E: Efficacy Guidelines.

What is ICH q5 guidelines?

ICH Q5C applies to well characterised proteins and polypeptides isolated or manufactured by rDNA technology. Shelf life should be derived from representative real time / real conditions data. Data can be provided during the review and evaluation process.


What is ICH Q8 guidelines?

A system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.

What is ICH Q8 Q9 and Q10?

a product meeting its predefined quality criteria. ICH Q8, Q9, and Q10 provide a. structured way to define product critical quality attributes, design space, the. manufacturing process, and the control strategy.

What is ICH Q11 guidelines?

The ICH Q11 general principles apply to the selection of starting materials for linear or convergent syntheses. The ICH Q11 general principles should be applied independently to each branch of a convergent synthesis, unless the point of convergence of the branches occurs upstream of an appropriate starting material.


What is ICH Q10 guidelines?

This document describes a model for an effective quality management system. It applies to the development and manufacture of pharmaceutical drug substances and drug products, including biotechnology and biological products, throughout the product lifecycle.

What is ICH M2?

The M2 Expert Working Group (EWG) was established by the ICH Steering Committee in 1994 with the objective of facilitating international electronic communication by evaluating and recommending, open and non-proprietary - to the extent possible - Electronic Standards for the Transfer of Regulatory Information (ESTRI) ...

How many modules are there in ICH?

For industries, it has eliminated the need to reformat the information for submission to the different ICH regulatory authorities. The CTD is organised into five modules. Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common for all regions.


What is ICH Q2 R2?

Q2(R2) Validation of Analytical Procedures August 2022

This guideline presents a discussion of elements for consideration during the validation of analytical procedures included as part of registration applications submitted within the ICH member regulatory authorities.

What is ICH Q2 R1 guidelines?

ā€œValidation of Analytical Procedures: Text and Methodology (ICH Q2(R1))ā€ published by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human (ICH) is a tripartite harmonized guideline that identifies validation parameters needed for variety of laboratory ...