What is a Stability Study?
A stability study is the evaluation of the ability of a pharmaceutical product to remain in its quality, safety and efficacy over a period under designated environmental conditions. It is critical in the establishment of shelf life, packaging, and storage rules. The regulatory bodies demand stability data so that medicines can be useful and safe during their required usage.
Purpose of Stability Studies
- Decides on the shelf life of the drug product.
- Determines the best conditions of storage (humidity, light, temperature).
- Checks the packaging system to guarantee product safety.
- Determines physical, chemical, microbiological and therapeutic stability.
- Assists in regulatory filing as well as product labeling.
Types of Stability Studies
- Long-term studies: Studies performed in recommended storing conditions (e.g., 25 o C, 60 RH) during a duration of up to 24 months.
- Accelerated studies: Conducted at a high condition (e.g. 40 O C/75 percent RH) to forecast long term behavior.
- Stress testing: Exposes the product to extreme conditions in order to determine degradation pathways.
- Intermediate studies: These are applied when the accelerated studies show substantial changes.
Regulatory Expectations
- Global harmonization by ICH guidelines Q1A1F.
- New Drug Applications (NDAs) and Abbreviated NDAs (ANDAs).
- Data should be contained in Common Technical Document (CTD) format.
- Maintains FDA, EMA, CDSCO and other regulatory authorities.
- The stability data accompanies the post-approval changes and surveillance of the market.
The stability tests play a vital role in guaranteeing the safety and efficacy of the pharmaceutical products during their lifecycle. They lead the strategy of formulating, packaging and regulation. To provide specialized assistance in pharmaceutical records and regulatory compliance, Masuu Global is able to offer customized services which will enable the companies to ensure adherence to global norms with certainty and accuracy.
