ICH Stability testing guidelines

ICH stands for “International Conference For Harmonization Of Technical Requirements For Pharmaceutical For Human Use” brings together the medicines regulatory authorities and pharmaceutical industry around the world.


The purpose of stability testing is to provide evidence on how the quality of a drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity & light.

1. Quality Control & Standardization Of Herbals ICH Stability Testing Of Guidelines By Kaushal Kumar

2. TABLE OF CONTENTS 01 02 03 04 Introduction Stability Testing Method Guideline Climate Zone

3. ICH stands for “ International Conference For Harmonization Of Technical Requirements For Pharmaceutical For Human Use ” brings together the medicines regulatory authorities and pharmaceutical industry around the world. The purpose of stability testing is to provide evidence on how the quality of a drug product varies with time under the influence of a variety of environmental factors such as temperature , humidity & light . Introduction

4. ☺ Real-Time Stability testing ☺ Accelerated stability testing ☺ Retained sample stability testing ☺ Cyclic temperature stress testing Stability Testing Methods

5. R Stability Testing Methods ACCELERATED STABILITY CYCLIC TEMP RETAINED In accelerated stability testing the samples are subjected to stress, refrigerated after stressing, & then assayed simultaneously . Because the duration of the analysis is short, the likelihood of instability in the measurement system is reduced in comparison to the real time stability test . Real time stability testing is normally performed for longer duration of the test period in order to allow significant product degradation under recommended storage condition. The min. & max. temperatures for the cyclic stress testing is recommended to be selected on a product by product basis & considering factors like recommended storage temperature for the product & specific chemical & physical degradation properties of the products. In this study, stability samples, for retained storage for at least one batch a year are selected. If the number of batches marketed excess 50, stability samples from two batches are recommended to be taken. Stability samples of every batch may be taken, which may be decreased to only 2% to 5% of marketed batches at a later stage.

6. Q1A – Stability testing of New Drug Substance & products Q1B – Stability Testing : Photo stability testing of New Drug Substance & products Q1C – Stability testing of New Dosage Forms Q1D – Bracketing & Matrixing Designs for stability testing of Drug Substance & Products. Q1E – Evaluation of stability data. Q1F – Stability data package for registration applications in climate zone III & IV Q5C – Stability testing of Biotechnological /Biological products. Guidelines For Stability Testing

7. Climate Zones ICH Stability Zones Zone Type of Climate Countries Zone I Temperate Zone UK, US Northern Europe Zone II Subtropical Zone Japan, S. Europe Zone III Hot Dry Zone Iraq, India Zone IV Hot Humid / Tropical Zone Iran, Egypt Zone IV b Higher Humidity Brazil, Singapore

8. Climate Zones Long Term Testing Conditions Climate Zone Temperature Humidity Min. Dur. Zone I 21°C± 2°C 45% ± 5% 12 Months Zone II 25°C ± 2°C 60% ± 5% 12 Months Zone III 30°C ± 2°C 35% ± 5% 12 Months Zone IV 30°C ± 2°C 65% ± 5% 12 Months Zone IV b 30°C ± 2°C 75% ± 5% 12 Months Refrigerated 5°C ± 3°C No Humidity 12 Months Frozen -15°C ± 5°C No Humidity 12 Months

9. Climate Zones Accelerated & Intermediated Testing Conditions Climate Zone Temperature Humidity Min. Duration Accelerated Ambient 40°C± 2°C 75% ± 5% 6 Months Accelerated Refrigerated 25°C± 2°C 60% ± 5% 6 Months Accelerated Frozen 5°C± 3°C No Humidity 6 Months Intermediate 30°C± 2°C 65% ± 5% 6 Months

10. Testing Guidelines These are the general stability guidelines for the drugs where specific storage conditions or testing of the drug is not required. Study Storage Condition Minimum Time Period Long Term 25°C ± 2°C / 60% RH ± 5% RH or 30°C ± 2°C / 65% RH ± 5% RH 12 Months Intermediate 30°c ± 2°C / 65% RH ± 5% RH Months Accelerated 40°C ± 2°C / 75% RH ± 5% RH 6 Months

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