09/09/2024
Refresh your knowledge about below:
1. Shelf-life of Medicinal Products.
2. How the shelf life is determined?
3. ICH recommended Stability zones.
4. ICH Stability Storage conditions with minimum requirements
🔵Shelf-life of Medicinal Products (Expiration Period) as per ICH Q1A:
The time period during which a drug product is expected to remain within the approved shelf-life specification provided that it is stored under the conditions defined on the container label.
🔵How the shelf life is determined?
Drug applicants to provide stability testing data with a proposed expiration date and storage conditions when they apply for respective agency approval of their drug. This testing is designed to provide confidence that the product will meet the applicable standards of strength, quality, and purity throughout its shelf-life.
The expiration date/shelf-life date is calculated by considering the release of the batch if released within 30 days of the production.
The date of production of a batch is defined as the date that the first step is performed involving combining the active ingredient with other ingredients (excipients). For medicinal products consisting of a single active ingredient filled into a container, the initial date of the filling operation is taken as the date of production.
🔵ICH recommended Stability zones.
🔹 Zone I: Temperate Zone
🔹Zone II: Mediterranean/Subtropical zone
🔹Zone III: Hot dry zone
🔹Zone IVa: Hot humid/tropical zone
🔹Zone IVb: Hot/higher humidity
Stability testing is a critical process in the pharmaceutical industry used to determine how the quality of a drug substance or drug product varies with time under the influence of environmental factors such as temperature, humidity, and light. This testing helps ensure that the drug remains safe, effective, and of high quality throughout its shelf life.
As the environmental conditions are different around the world, accordingly regions are classified into various zones, as mentioned in my last post.
Here is a citation of a few territories per the assigned climatic zone for the stability testing.
🌍Zone I: Russia
🌍Zone II: United States, Europe, Canada, Australia, New Zealand, China, Iran, Israel, Japan, Kazakhstan, Kirghizia, Korea, Libya, Mexico, Morocco, Namibia, Nepal, Oman,
🌍Zone III: Chad, Iraq, Jordan
🌍Zone Iva: Bahrain, Bangladesh, Barbados, Belize, Benin, Bolivia, Brazil, Burkina Faso, Burundi, Congo, Costa, Dominican Republic, Dutch Antilles, Ecuador, EI Salvador, Ethiopia, Fiji, Gabon, Gambia, Guatemala, Gunia, Haiti, Honduras, Hong Kong, Ivory Coast, Jamaica, Kuwait, Liberia, Madagascar, Malawi, Maldives Islands, Mali, Marshall Islands, Rico, GCC, Pakistan
🌍Zone IVb: India, Barbados, Bolivia, Central African Republic, Columbia, Cuba, Ghana, Guyana, Indonesia, Lao, Malaysia, Mozambique, Myanmar, Nigeria, Panama, Peru, Philippines, Singapore, Tanzania, Togo, Thailand, Venezuela, Vietnam.
Thanks & Regards,
Aryabrat International Pte Ltd [AIPL]