Stability testing is significant throughout drug research and development, clinical trial, marketing and post-market quality research. As a basic factor for determining a product’s expiration dates and quality standards, stability testing provides the basis for a drug’s production process, formulation, packaging materials, storage, and transportation.

Biological products are more sensitive to environmental factors such as temperature, humidity, and light. To ensure the biologics are safe and effective and keep them from inactivation or degradation, stability testing must be carried out according to the products’ characteristics.

The Guidelines applies to the biological products’ stability research design and result analysis. For some special varieties, such as gene therapy and cell therapy products, research should be carried out according to their characteristics.

The Guidelines aims to standardize the research and evaluation of biological products’ stability test so as to make the relevant work more comprehensive, scientific, and effective.