FDA Draft Guidance (Withdrawn): Validation of Blood Establishment Computer Systems, 9/93
$0.00
September, 1993 CBER draft guideline regarding blood establishment system validation testing, change control, security, audit trails, SOPs, manuals, training, maintenance, and audits.
NOTE: The FDA withdrew this guideline in March, 2005
| Issuing Body | FDA Guidance Documents |
|---|
You may also like…
-
FDA 21 CFR 606: cGMP for Blood and Blood Components
21 CFR 606 specifies current Good Manufacturing Practices for blood and blood products.
$0.00 Add to cart -
FDA Guidance: Blood Establishment Computer System Validation in the User’s Facility, 4/13
In April, 2013, the FDA published this guidance to assist blood establishments in developing computer system validation programs consistent with recognized principles.
$0.00 Add to cart -
FDA Guidance: Changes to an Approved Application: Biological Products: Human Blood and Blood Components, 12/14
This December 2014 US FDA guidance provides manufacturers of licensed blood and blood components with recommendations on submission of BLA changes.
$0.00 Add to cart
