The Biopharmaceutical Manufacturing Facilities Baseline Guide may be used by industry for the design, construction, commissioning, and qualification of new facilities for the manufacture of biopharmaceutical Active Pharmaceutical Ingredients (APIs).
The appendices consider non-U.S. regulatory differences, with input by ISPE Members from both Europe and Asia - particularly Japan.
Document identifier
ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities
ISPE Category
Baseline Guides
Publication date
2004-06-01
International Relationship
History of version
ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities*ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities * ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities * ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities
| Price |
Contact |
ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities
.jpg){kind=logo}
---Logo.jpg){kind=logo}
.jpg){kind=logo}
-_-logo.png){kind=logo}
.jpg){kind=logo}
.png)
