ICH stability Guidelines Q1A – Q1F

ICH stability Guidelines Q1A to Q1F:

This Guidelines have been developed by the appropriate ICH Expert Working Group and have been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process, the final draft is recommended for adoption by the regulatory bodies of the European Union, Japan and the USA

Below are all ICH stability guidelines;

Q1A (R2): Stability Testing of New Drug Substances and Products:

This Guideline has been revised a second time and reached Step 4 of the ICH process in February 2003. This Guideline provides recommendations on stability testing protocols including temperature, humidity and trial duration for Climatic Zone I and II. Furthermore, the revised document takes into account the requirements for stability testing in Climatic Zones III and IV in order to minimize the different storage conditions for the submission of a global dossier.

Date of Step 4: 6 February 2003

Status Step 5: Implementation

Q1B Stability Testing: Photostability Testing of New Drug Substances and Products:

The ICH Harmonised Guideline was finalized under Step 4 in November 1996. This document is an annex to the main ICH stability Guideline and gives guidance on the basic testing protocol required to evaluate the light sensitivity and stability of new drugs and products.

Date of Step 4: 6 November 1996.

Status Step 5: Implementation

Q1C: Stability Testing for New Dosage Form:

The ICH Harmonised Guideline was finalized under Step 4 in November 1996. It extends the main stability Guideline for new formulations of already approved medicines and defines the circumstances under which reduced stability data can be accepted.

Date of Step 4: 6 November 1996.

Status Step 5: Implementation

Q1D: Bracketing and Matrixing Designs For Stability Testing Of New Drug Substances and Products:

The ICH Harmonised Guideline was finalized under Step 4 in February 2002. This document is intended to address recommendations on the application of bracketing and matrixing to stability studies conducted in accordance with principles outlined in the main stability Guideline.

Date of Step 4: 7 February 2002.

Status Step 5: Implementation

Q1E: Evaluation of Stability Data:

The ICH Harmonised Guideline was finalized under Step 4 in February 2003. This document extends the main stability Guideline by explaining possible situations where extrapolation of retest periods or shelf-lives beyond the real-time data may be appropriate. Furthermore, it provides examples of statistical approaches to stability data analysis.

Date of Step 4: 6 February 2003.

Status Step 5: Implementation

Q1F: Stability Data Package for Registration Application in Climatic Zones III and IV:

The ICH Steering Committee endorsed the withdrawal of the Q1F Guideline at the Yokohama meeting in June 2006 and decided to leave the definition of storage conditions in Climatic Zones III and IV to the respective regions and WHO.

Status: Withdrawn in 2006.

Q1/Q5C Informal WG: Targeted Revisions of the ICH Stability guideline series:

This topic was endorsed by the ICH Assembly in June 2021, and an informal Working Group has been established to develop a Concept Paper and Business Plan.

Note: All ICH stability guidelines source is from the Official ICH Website

ICH stability Guidelines
ICH Stability Guidelines

ICH stability Guidelines

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