Stability Studies of Pharmaceutical Packaging Materials in China
The regulatory landscape in China continues to evolve and become more stringent. In December 2018, the Chinese Pharmacopoeia Commission (ChPC) published: Second Draft for Comments on Guideline for Stability Study of Plastic and Rubber Pharmaceutical Packaging Materials. This guideline comprises part of the results of a research project organized by ChPC in 2016 and is one of the actions taken by National Drug Administration of China (formerly the China Food and Drug Administration, CFDA) to support the previously announced Opinions on Reforming the Review and Approval System for Drugs and Medical Devices (No. 44).
Second Draft … was revised based on comments received on the first draft, which was published in February 2018. Both drafts note that the purpose of a stability study is to investigate the performance of primary plastic and rubber packaging materials with time , under defined temperature and humidity conditions. The study will provide a scientific basis for manufacturers of packaging materials to identify and recommend storage conditions and effective shelf life. The shelf life of the packaging materials from the pharmaceutical manufacturer’s perspective should start from the manufacture date of the packaging material, to the end of the drug product shelf life.
Key points of Second Draft … include:
- The stability study consists of three areas: factors influencing packaging materials, accelerated aging and real-time aging.
- The packaging of samples should be the same as, or equivalent with, the packaging of the commercial products.
- If drug product is expected to be stored at low temperature, a low temperature real-time aging study is required.
- The evaluations include characteristics relevant to functionality, protection, and safety.
- A minimum of “1 batch” is required , vis-à-vis “3 batches” in the first draft.
Comments are being collected for Second Draft … – the timeline for official release is not known yet. The West Scientific Affairs team will remain vigilant on this, and other regulatory matters, in order to help customers effectively navigate the regulatory landscape.