Interview with MERCK

Ahead of the upcoming Extractables & Leachables China 2020 conference, we caught up with Queenie Gai, Global E&L Senior Consultant at Merck. She gave us a sneak peek of what we can expect from her presentation on day one, taking place during our 'Global Regulatory Landscape and Updates on E&L' session.

Current Industry Focus:

Q. As consumers/end users continually push for more safer solutions, what do you think is the biggest concern regarding Extractables and Leachables?
The biggest concern is what we do with extractables and leachables data. Ultimately we must perform a patient safety evaluation which consist of determining whether or not the compounds identified may migrate from the plastic elastomer into the drug would cause safety concern for the patient.  

Q. What are some of the biggest opportunities gaining attention within the Extractables and Leachables field? How has your company chosen to react/adapt to stay on trend?
Biggest opportunities is the industry moving toward a standardized approach for extractables. That will significantly simplify and accelerate extractables evaluation, while maintaining equal safety requirements. Our company has decided to follow guidance from the industry and have developed standard extractables data that covers more than 600 components (Merck components and also 3rd party components) of Merck Mobius single use library. This unique database includes all model solvents and timepoints according to BioPhorum and draft USP<665> guidelines. Within 2 weeks, our customers can build their own standard extractables library. This solution is part of Merck Emprove® Program which aims to confidently speed our clients' way through the regulatory maze and fast track new drug to market.
Future Focus:

Q. What industry topics are getting the most attention at this time? How are these factors influencing the future of pharmaceutical packaging/medical device materials (of plastic components and systems used in pharma and biopharma manufacture)?
USP 665 and USP 1665 draft and <化学药品注射剂生产所用的塑料组件系统相容性研究技术指南(试行)> get the most attentions at this time.  These will provide clearer instructions to both supplier and end user.

Q. What does your company/organization hope to achieve over the next 5 years with regards to the future of pharmaceutical (packaging)/medical device industry (of plastic components and systems used in pharma and biopharma manufacture)?
Our objective is to be able to support our customers with extractables data and without performing any extractables testing. 

Q. What do you expect the future regulatory landscape of Extractables and Leachables in China is going to be?
The future regulatory landscape of E&L in China will speed up its alignment with global regulatory environment, continue to evolve. 
Conference Related:

Q. Your presentation at this year's E&L China will cover 'Interpretation of USP 665 latest revision: how standardized extractables data support E&L risk assessment of manufacturing process'. Why is it important for others in your industry to hear this message? What are some of the key take-aways?
USP <665> new draft gets the most attention at this time, it plays a critical role for both supplier and end user.
  • Current industry guidelines established by USP <665> draft
  • End user's process materials risk management
  • The use of standard extractables data from SUS supplier for risk mitigation 

Q. Which presentations (what session topic) are you most looking forward to hearing about at E&L China? 
I would like to hear more about case studies – especially unknown compound. Also some topics deliver by Chinese officers from CDE(NMPA).