Stability and Stability Zone

By Dhansukh Viradiya

⭐ Stability:

What is Stability? 

➡️ Ability of a drug product to remain unchanged over time under stated or reasonably expected conditions of storage and use.

Why stability study will perform? 

➡️ To establish a shelf life for the drug product and recommended storage conditions.

Selection of stability Batches:

➡️ Data from stability studies should be provided on at least three primary batches of the drug product. The primary batches should be of the same formulation and packaged in the same container closure system as proposed for marketing.

⭐ Stability Zone:

How many stability zone? 

➡️ Based on climate of world, ICH classified world in total four stability zones as per following. 

➡️ The stability zones are classified based on its different temperature and humidity condition. 

➡️ Stability studies of drug product depends on climate zone of different countries.

⭐ Stability testing:

What is purpose of stability testing? 

➡️ It is provide document 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, and light, and to establish a shelf life for the drug product and recommended storage conditions.

Types of stability testing:

1. Long term testing:

➡️ Stability studies under the recommended storage condition for the re-test period or she life proposed (or approved) for labeling.

2. Intermediate testing:

➡️ Studies conducted at 30°C/65% RH and designed to moderately increase the rate of chemical degradation or physical changes for a drug substance or drug product intended to be stored long term at 25°C. 

3. Accelerated testing:

➡️ Studies designed to increase the rate of chemical degradation or physical change of a drug substance or drug product by using exaggerated storage conditions as part of the formal stability studies.

Different stability zone wise countries are as per below map.

About the Author:

Dhansukh Viradiya is a highly accomplished expert in the pharmaceutical and biopharmaceutical industries. With over 10 years of experience in the field, he has gained comprehensive knowledge and expertise in various areas, including Process Validation, Cleaning Validation, Quality Management System, In-process quality assurance, Qualification etc.

Mr. Dhansukh holds a Master's degree in Pharmacy from a renowned University, where he specialized in Quality Assurance. 

As a thought leader, Mr. Dhansukh has published numerous articles and white papers on various topics related to pharmaceutical and biopharmaceutical industries. His research work focuses on emerging trends, current regulatory expectations, advancements in technology, personalized medicine, and the intersection of healthcare and technology.

With his passion for improving patient care and dedication to advancing the field, Dhansukh Viradiya continues to make significant contributions to the pharmaceutical and biopharmaceutical industries. His insights and expertise make him a valuable resource in understanding the dynamic landscape of these sectors and their impact on global healthcare.

Disclaimer: The author's biography is provided for informational purposes only and does not imply any endorsement or affiliation with the article or its content.