Hardware Podcasts

229 -Outsourcing Analytical Testing: What Sponsors Get Wrong in Combination Products

Let's Combinate · 11 Mar 2026 · 31m

What this episode covers

Jen Riter, an analytical testing leader with experience at West Pharmaceutical Services and Kindeva Drug Delivery, explains the critical differences between validating chemical methods under ICH Q2 and functional/mechanical methods for combination products. She details the necessity of using an engineering mindset, including Measurement System Analysis (MSA) and gage R&R, and the use of fabricated surrogate standards like metal syringes to validate performance methods. The discussion covers leveraging ISO 11040 for platform methods, the verification versus validation debate between ISO and USP standards, and strategic decisions regarding outsourcing specialized testing such as Container Closure Integrity Testing (CCIT) and extractables/leachables to contract laboratories.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
West Pharmaceutical Services, Kindeva Drug Delivery
Also
ICH Q2, ISO 11040, USP 382, CCIT

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