Zobrazeno 1 - 2
of 2
pro vyhledávání: '"David Estape"'
Publikováno v:
PDA journal of pharmaceutical science and technology. 75(4)
This article details a risk-based methodology designed to assign environmental classifications to the different operations in biopharmaceutical facilities manufacturing non-sterile (low bioburden) drug substance. Generally, environmental conditions f
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::70c65958eaab8c372852455d2cae1fa6
https://pubmed.ncbi.nlm.nih.gov/33443138
https://pubmed.ncbi.nlm.nih.gov/33443138
Autor:
Kavita Ramalingam Iyer, Alan Powell, Tim Corbidge, Robin Payne, David Estape, Ken Green, Phil Mcduff, Paul Smock, Jeff Blake, Johnson Jeffrey Charles, Scott Probst, Marc Pelletier
Publikováno v:
PDA journal of pharmaceutical science and technology. 70(3)
This paper is an interpretive response to Annex 2 of Eudralex—Volume 4; the European Union (EU) guidelines for good manufacturing practice (GMP) of medicinal products for human and veterinary use ([1][1]). It was written collaboratively, by a team
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5304a8913f65c24d83d07535073b7409
https://pubmed.ncbi.nlm.nih.gov/27020646
https://pubmed.ncbi.nlm.nih.gov/27020646