Q1A (R2) Stability ICH guideline purpose of revision

Before understanding the purpose for the revision of stability ICH guidelines need to understand what ICH stands for.

What is ICH Full form?

ICH stands for “International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use”

Q1A (R2) Stability ICH Guideline Purpose Of Revision:

The purpose of the stability ich guideline is to outline the changes made in Q1A(R) that result from the adoption of ICH Q1F “Stability Data Package For Registration Application in climatic zones III and IV”.

These changes are mentioned below:

1. The Intermediate storage condition has been changed from 30°C ± 2° C/60% RH ± 5% RH to 30°C ± 2°C/65% RH ± 5%RH in the following sections:

  • Drug Substance- Storage Conditions- General Case
  • Drug Substance- Storage Conditions – General Case
  • Drug Products packages in semi-permeable containers
  • Glossary- Intermediate Testing.

2. 30°C ± 2°C/65%RH ± 5% can be a suitable alternative long-term storage condition to 25°C ± 2°C/60% RH ± 5%RH in the following sections:

  • Drug Substance – Storage Conditions – General Case.
  • Drug Product – Storage Conditions – General Case

30°C ± 2°C/35% RH ± 5% RH has been added as a suitable alternative long-term storage condition to 25°C ± 2°C/ 40% RH ± 5% RH and the corresponding example for the ratio of water-loss rates have been included in the following sections:

  • Drug Products packaged in semi-permeable containers

Mid-stream switch of the intermediate storage condition from 30°C ± 2°C / 60% RH ± 5 % RH can be appropriate provided that the respective storage conditions and the date of the switch are clearly documented and stated in the registration application.

It is recommended that registration applications contain data from complete studies at the intermediate storage condition 30°C ±2 °C/65 % RH ± 5% RH, if applicable, by three years after the date of publication of this revised guideline in the respective ICH tripartite region.

The Stability ICH Guideline helps to determine the shelf life of drug products or to understand the behavior of the drug product till its lifecycle.

Stability ICH guideline
Stability ICH Guideline

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