Search results for " capture"
Article
The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…
Article
Quality by design for biotechnology products—part 1
The paper is intended to capture and reflect both the current and future state of QbD implementation. Therefore, new tools and terminology (e.g., expanded change protocol and the post-approval managem…