Overview: Although the concept of test method validation is based on good science, the expectation that test methods in the pharmaceutical industry be validated was established by the USP in the 1980s ...

Swab recovery parameters are reviewed in detail to define best practices and highlight common mistakes to assure successful recovery studies using a risk-based approach. Parameters affecting cleaning ...

Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...

This article considers the distinction among the terms qualification, validation, and verification in the context of pharmacopeial usage.A recommendation for a standardized usage of the terms ...

This article is a condensed version of an article that appeared in the November/December 2022 issue of Chip Scale Review. Adapted with permission. Read the original ...

Single-use bioreactors have been successfully implemented by the biopharmaceutical industry up to the 2,000-L scale. The performance of single-use bioreactors is comparable if not superior to ...

(MENAFN- GlobeNewsWire - Nasdaq) Dublin, Feb. 13, 2025 (GLOBE NEWSWIRE) -- The "Analytical Method Validation, Verification and Transfer Course" training has been added to ResearchAndMarkets.com's ...