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 ...

Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Shiri Hechter, senior lab operations manager for Nelson Laboratories, provide a simple approach to validating ...

Dublin, April 21, 2023 (GLOBE NEWSWIRE) -- The "Analytical Method Validation, Verification and Transfer Virtual Seminar" training has been added to ResearchAndMarkets.com's offering. Dependable ...

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 ...

In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA ...