China Accelerates Internationalization of Their Pharmaceutical Guidelines

Since China has applied for PIC/S pre-accession in September 2021, interest in adopting PIC/S GMPs is growing. Descriptions in Chinese GMPs and the Chinese Pharmacopoeia sometimes differ from PIC/S GMPs or the ICH Quality Guidances, so the questions that follow were raised at a recent stability storage seminar for China’s Stabilitarians. Answers were supplied by Nagano Science, a leading manufacturer of stability chambers in Japan.

Can the parameters for stability testing of biologics be adopted from the 2020 Chinese Pharmacopoeia?
You should refer to both the 2020 Chinese Pharmacopoeia and ICH Q5C to reconcile factors that could influence biologics stability testing in China.

The Accelerated storage condition for semi-permeable containers is described as 40℃ NMT 25%RH in ICH, while described as 40℃/25%RH in the 2020 Chinese Pharmacopoeia. How should we reconcile this difference?
The ICH document should be translated into a Chinese document and you can refer to that.

When should stress testing should be performed?
Stress testing should be scheduled during the earlier development stage and probably repeated just before the time of application.

When the storage condition of drug product would be below 25℃ or in a cool place in the shade, would the stability test condition be 5℃, or 25℃?
When the storage condition is below 25℃, stability testing at 25℃ 60%RH should be appropriate. There is no stability test description for product storage in a cool place in the shade.

How often should mapping studies for re-qualification of stability chambers be conducted and what is a recommended time interval for measuring temperature and humidity?
For the frequency of the mapping interval, it should be justified or by risk evaluation regarding how long the chamber sensors hold their precision within pre-established limits, estimating replacement of key equipment parts or significant load patterns change (usually every 1 to 2 years in US and 1 year in Japan). For measuring temperature and humidity, 24 hours and at 5 minutes interval is the recommendation to confirm the stable function during the changes of condition of surrounding temperature and voltage fluctuation.

China shows great interest in the business of biological products, and other seminars are planned in conjunction with their National Medical Products Administration (NMPA).