Guideline for Self-Stability Study on Plastic and Rubber Pharmaceutical Packaging Materials

The self-stability study on pharmaceutical packaging materials is designed to investigate change rule of the packaging materials and containers in direct contact with drugs (hereinafter referred to as pharmaceutical packaging materials) over the time under specified temperature and humidity environment so that scientific basis can be established for storage conditions and expiration date of pharmaceutical packaging materials combination with drugs determined by drug manufactures.
Attachment：Guideline for Self-Stability Study on Plastic and Rubber Pharmaceutical Packaging Materials(T/CNPPA 3017-2021)