Interview with Sci-Tech
Ryan Yang, Department Director from Sci-Tech will be presenting at next week's Extractables & Leachables China 2021, discussing challenges caused by the pandemic.
Q. What are the biggest challenges facing the E&L sector (in China)?
Read on to hear his thoughts on the biggest priorities for medical device and pharmaceutical companies and how the future regulatory landscape will impact E&L studies in China.
Take a look below now to find out what was said...
I think the following three aspects are the current challenges. First, the key risk points of polymers in the pharmaceutical field and the spectrum of toxic substances released are not clearly defined and standardized. Second, for the discovery, identification and identification of the extracted unknown, there is no general and comparable test program in the industry, which can also be understood as a threshold standard; With the threshold standard, repeated experimental research in the industry can be reduced, and the selection of polymer packaging materials and components to be used by users will become simple. Third, there is still a long way to go based on "safety" judgment standards for different products and fields.
Q. What are the biggest priorities for medical device and pharmaceutical companies when it comes to E&L studies?
For pharmaceutical and pharmaceutical companies, ensuring "safety" has always been the priority focus of their supplier selection process and design research scheme. The safety profile of the products supplied can be preliminarily understood through the certificates, formulas, compliance statements, etc. provided by the supplier, and on this basis, the scope of known risk targets can be determined; Further identify possible risk points in future products or process flow by means of full scanning of unknown substances and toxicological evaluation, design targeted unknown substance extraction research scheme, select experimental methods with sufficient sensitivity to find and identify specific targets for further monitoring, and formulate appropriate release standards.
Q. What technical issues to you think still need to be addressed in the future?
1. Broad spectrum and applicable unknown multi-target screening method is the key point of continuous attention in E / l field;
2. The most advanced analytical techniques should be considered for the quantification of unknown substances, and the research data from multiple sources should be comparable and reproducible;
3. The safety threshold of transdermal preparations, eye drops, oral solutions and other dosage forms need to be further defined and a consensus needs to be formed.
Q. How do you think the future regulatory landscape will impact E&L studies in China?
"Safe, effective and controllable quality" is the basic requirement of regulators for the industry. Establishing access standards for various materials and components, promoting research institutions to form standardized and wide-ranging research schemes in the E / l field, and emphasizing the comparability and standardization of research data will become an important direction of the new regulatory rules.
Q. What opportunities are there for harmonization of pharmaceutical packaging/ single use systems/medical devices in China and the rest of the Asia Pacific region?
Recent research cases show that the regulatory requirements and research ideas of drug packaging materials and components tend to be consistent, and a high degree of attention has been paid to the discovery, identification and quantification of unknown extractables. Medical equipment has its own unique characteristics in E / L due to its complexity, diversity and wide application. A large part of the basic raw materials and components used are basically consistent with drug packaging materials and components. I think this part can converge in terms of access standards and research schemes.
Q. What are you most looking forward to at the conference of E&L China?
I look forward to seeing special cases, solutions, research progress in unknown identification and quantification, and the selection and interpretation of safety assessment domain values for different dosage forms and products at this conference.