Module 3 Presentations

07/05/2024

Climatic zones and long term stability conditions (ICH)

Climatic Zone

Climate/ Definition

Major Countries/ Region

MAT/ MAPWVP

Long-term testing conditions

I

Temperate Zone

Southern Canada, Europe, parts of Russia Mediterranean region, parts of Australia, southern USA North Africa, Middle East, desert areas in the USA Southeast Asia, Central Africa, parts of South America Regions near the equator, dense rainforest areas

< 15°C / < 11 hPa

21°C / 45% RH

II

Mediterranean/ Subtropical Zone

> 15 – 22°C / > 11 – 18 hPa

25°C / 60% RH

III

Hot/Dry Zone

> 22°C / < 15 hPa

30°C / 35% RH

IVa

Hot Humid/Tropical Zone

> 22°C / > 15 to 27 hPa

30°C / 65% RH

IVb

Hot/Higher Humidity Zone

> 22°C / > 27 hPa

30°C / 75% RH

MAT = Mean annual temperature measured in open air MAPWVP = Mean annual partial water Vapor Pressure

The Organisation for Professionals in Regulatory Affairs

43

Guidelines for stability testing: ICH Guidelines

ICH Code Q1A(R2)

Title

Stability Testing of New Drug Substances and Products

Q1B

Stability Testing : Photostability Testing of New Drug Substances and Products

Q1C Q1D

Stability Testing for New Dosage Forms

Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products

Q1E Q1F

Evaluation of Stability Data

Stability Data Package for Registration Applications in Climatic Zones III and IV (Guideline withdrawn on 8 June 2006)

Q5C

Stability Testing of Biotechnological/Biological Products

Source: http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html

The Organisation for Professionals in Regulatory Affairs

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