ICH Q1A - Q1F Stability Guidelines

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Q1A - Q1F Stability

ICH Q1A - Q1F Stability Guidelines, Q1A (R2) Stability Testing of New Drug Substances and Products  This Guideline has been revised a second time and has 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 submission of a global dossier.

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


This Guideline has been revised a second time and has 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 submission of a global dossier.


Date of Step 4: 6 February 2003


Status: Step 5


Guidelines (Click the links below for complete guidelines)


Q1A (R2) Guidelines


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 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


Guidelines (Click the links below for complete guidelines)


Q1B Guidelines


Q1C Stability Testing for New Dosage Forms


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


Guidelines (Click the links below for complete guidelines)


Q1C Guidelines


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


Guidelines (Click the links below for complete guidelines)


Q1D Guidelines


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


Guidelines (Click the links below for complete guidelines)


Q1E Guidelines


WG Presentations / Trainings (Click the links below for complete guidelines)


Q1E Presentation


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


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


Other Documents (Click the links below for complete guidelines)


Q1F Stability Guideline WHO 2018

Q1F Explanatory Note


*These Guidelines Belongs to ICH website.

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