Search results for " equipment"

Article Essentials in Quality Risk Management
All unit operations, formulations, analytical methods, excipients, cell banks, working cell banks, equipment, reagents, chemistry, facilities, and materials are evaluated for the potential influence t…

Article Flexibility in Biopharmaceutical Manufacturing
Maintaining flexibility in biopharmaceutical manufacturing can deliver positive results. By: Simon Chalk BioPharm International There is a high degree of consensus in the biomanuf…

Article A Look Ahead at BioPharma Manufacturing and Regulation
The FDA talks about the changing scope of regulatory science. Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of r…

Article Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech. By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…

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