I sat down recently with Matt Boggess, Staff QC Engineer/Scientist, Patheon, and PPD's Senior Principal Scientist Derek Wood and Xiaochun Yu, to talk about practical considerations of implementing Extractables & Leachables studies in a modern laboratory.
I asked....
All: Can you give viewers a quick overview of your roles and companies?
Matt: For those new to the topic of extractables and leachables, can you give us a brief definition, and why do they matter?
Matt: Why are risk assessments so critical in supporting new Drug Product registrations? What is the driver for ensuring that Risk Assessments are performed? 04:00
Matt: What is the most challenging aspect of executing a PERL risk assessment? 05:36
Matt: How do you determine which components are “in-scope” for a PERL RA? 06:23
Matt: What is your most common frustration when attempting to execute a PERL risk assessment? 06:66
Matt: I understand that you propose a two pronged approach to executing PERL Risk Assessments. One targeting organics and a second for elementals. Why do you feel this is most efficient and or what is the motivation for doing so? 07:53
Derek: After the risk assessment is completed and at-risk components designated what are the next steps? 09:31
Derek: How is such an evaluation conducted? 09:50
Derek: You mentioned analytical evaluation using headspace GC/MS, direct injection GC/MS, LC/UV/MS, and ICP-MS. What are the key aspects of the methodologies that are utilized? 14:14
Xiaochun: Can you talk a little about the extractables and leachables study for the manufacturing components, and how this is differs to container/closure components? 15:48
Xiaochun: You mentioned that the extractables/leachables study is also guided by the safety concern threshold and analytical evaluation threshold, but some the manufacturing components are not exposed to the final product solutions, how do you calculate the AET? 19:25
Xiaochun: What are the main challenges for the extractables and leachables study for manufacturing components? 20:27
Find out how PPD, Patheon and Thermo Fisher Scientific can help you with all things E&L by exploring the links below;
www.ppd.com/our-solutions/ppd...
www.patheon.com/us/en/our-cap...
www.thermofisher.com/uk/en/ho...
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