SUBSCRIBE

Breaking News on Global Pharmaceutical Technology & Manufacturing

Headlines > Regulatory & Safety

Read more breaking news

 

 
News in brief

US FDA revises blood storage and testing rules for manufacturers

29-Aug-2012
Last updated on 29-Aug-2012 at 13:13 GMT

The US FDA has revised storage and testing requirement for human blood intended for transfusion or further manufacturing.

According to a document published yesterday manufacturers can now store thawed fresh frozen plasma at 1-6°C for 24 hours

Additionally, pharmaceutical manufacturers will no longer have to test blood samples for HIV and HCV from donors whose previous samples have tested positive for HIV and HCV antibodies, which indicates that  they have been exposed to the infections.

The FDA said: “These donors participate in a Source Plasma High Risk Donor program and their plasma with be used for further manufacturing into non-injectable products.”

The revisions update the original guidance, which is available here

Related products

Key Industry Events

 

Access all events listing

Our events, Events from partners...

Products

Solid Lipid Excipients: Born to be Extruded !
Gattefossé Pharma
USP<233> Elemental Impurities Sample Prep Strategy
SGS Life Science Services
Online Cell Density Monitoring
Hamilton Bonaduz AG
Residual moisture in lyophilized pharmaceuticals
Metrohm – customized analysis for the pharmaceutical industry