Recommended Best Practices for Lyophilization Validation 2021 Part II: Process Qualification and Continued Process Verification

This work describes the lyophilization process validation and consists of two parts. Part one (Part I: Process Design and Modeling) focuses on the process design and is described in the previous paper, while the current paper is devoted to process qualification and continued process verification. Th...

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Detalles Bibliográficos
Autores principales: Jameel, Feroz, Alexeenko, Alina, Bhambhani, Akhilesh, Sacha, Gregory, Zhu, Tong, Tchessalov, Serguei, Sharma, Puneet, Moussa, Ehab, Iyer, Lavanya, Luthra, Sumit, Srinivasan, Jayasree, Tharp, Ted, Azzarella, Joseph, Kazarin, Petr, Jalal, Mehfouz
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8575750/
https://www.ncbi.nlm.nih.gov/pubmed/34750693
http://dx.doi.org/10.1208/s12249-021-02107-6

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8575750/
https://www.ncbi.nlm.nih.gov/pubmed/34750693
http://dx.doi.org/10.1208/s12249-021-02107-6

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