Specification-driven acceptance criteria for validation of biopharmaceutical processes

Intermediate acceptance criteria are the foundation for developing control strategies in process validation stage 1 in the pharmaceutical industry. At drug substance or product level such intermediate acceptance criteria for quality are available and referred to as specification limits. However, it...

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Detalles Bibliográficos
Autores principales: Marschall, Lukas, Taylor, Christopher, Zahel, Thomas, Kunzelmann, Marco, Wiedenmann, Alexander, Presser, Beate, Studts, Joey, Herwig, Christoph
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Bioengineering and Biotechnology
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9537461/
https://www.ncbi.nlm.nih.gov/pubmed/36213075
http://dx.doi.org/10.3389/fbioe.2022.1010583

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9537461/
https://www.ncbi.nlm.nih.gov/pubmed/36213075
http://dx.doi.org/10.3389/fbioe.2022.1010583

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