Ahead of her presentation at the much-anticipatedExtractables and Leachables China 2019, we spoke to Fangfang Zhang, Senior Engineer - Deputy Director of Analysis Department at Shanghai Food and Drug Packaging Material Control Center, to discuss evaluation strategies for comparability of container closure system, future significant changes to regulations and more.
Q. You will be speaking on Evaluation strategy for comparability of container closure system. Can you give us a brief insight into what areas you covering in your speech?
The design of E&L experimental scheme on quality consistency evaluation of container closure system based on the guidelines in China.
Q. In your opinion, what is the #1 takeaway of your presentation?
I think it is product quality consistency by E&L experimental scheme design.
Q. What do you see as the most significant changes coming up in the E&L regulations in China in the next 12-24 months?
The E&L regulations about pharmaceutical in China may be mainly related to quality consistency evaluation, especially in the stability of product quality combined with drug approval and evaluation. The E&L regulations about food contact material may continue to promote the construction food contact material standard. And all the most, enterprise is the first responsibility for quality.
Q. What are the biggest challenges that you see across the sector?
The challenges I think may be big data integration which can divide into two part, one is degradation origin confirmation, the other is effective widely recognized biocompatibility data. And at the same time keep E&L uniformity in different countries.
Q. Why do you feel it’s important for companies to attend E&L China 2019?
E&L China 2019 brings together experts in E&L from all over the world who may introduce the preface, policy and E&L research, and this may promote the quality both in the manufacturing company and in technical service institutions.
Q. Who are you most looking forward to at E&L China 2019?
Fangfang will be presenting as part of the Focus on Packaging session at the event this November. Other speakers in the session include Becton Dickinson Medical Devices (Shanghai) and Tiankun Pharma.
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