ARLINGTON, Va., Oct. 25, 2017 /PRNewswire-USNewswire/ -- The Bio-Process Systems Alliance (BPSA) announced today
The uptake of single-use technologies (SUT) in more critical good manufacturing practices (cGMP) processes and applications has made assurance of integrity a critical quality attribute for both suppliers and end-users.
"I expect this to be one of the most significant documents written in the last five years to support our mission of driving the adoption of single-use technologies worldwide," said Kevin Ott, BPSA Executive Director.
The document provides recommendations to both suppliers and end-users in the single-use technology industry regarding strategies, tools and procedures that can assist in providing enhanced assurance of integrity of single-use systems. It can help end-users convey their specific requirements to the supplier. In turn, suppliers can use the document to demonstrate what they can provide to the end-user.
The technical guide divides best practices into two separate but complementary sections a risk-based approach and practical tests for SUTs.
The document was written by a working group of end-users and suppliers who recognized the need to provide guidance in the absence of industry standards.
About BPSA The Bio-Process Systems Alliance (BPSA) is an industry association whose mission is dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of pharmaceuticals and vaccines. BPSA facilitates education, sharing of best practices, development of consensus guides, and business-to-business networking opportunities among its member company employees. For more information on BPSA, visit www.bpsalliance.org.
Contact: Kevin Ott Executive Director Bio-Process Systems Alliance (BPSA) firstname.lastname@example.org www.bpsalliance.org
View original content:http://www.prnewswire.com/news-releases/bpsa-releases-technical-guide-for-design-control-and-monitoring-of-single-use-systems-for-integrity-assurance-300543414.html
SOURCE Bio-Process Systems Alliance (BPSA)
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