Bio-Process Systems Alliance releases Consensus Quality Agreement for single-use products
It is available to both suppliers and users single-use products after two years in development
The Bio-Process Systems Alliance (BPSA), a US trade association of the single-use bio-processing industry, has released its 2014 Consensus Quality Agreement for single-use biopharmaceutical manufacturing products.
Known as the BPSA 2014 Quality Agreement Template (QAT), the 19-page guidance document is the result of a two-year effort led by a committee of BPSA members. Quality experts from GE Healthcare, EMD Millipore, CPC, Value Plastics, Sartorius-Stedim Biotech, BIA Separations, Advantapure/New Age Industries, GSK Vaccines, Pall Corporation, Merck and Co, and Sanofi Pasteur all assisted in bringing this project to fruition.
The QAT addresses the need for a common structure for quality agreements between single-use suppliers and users. Specifically, it provides structure to the dialogue between users and customers that immediately focuses on common ground, thus streamlining the negotiation process.
'It is important that the BPSA QAT involves both single-use suppliers and the users of single-use, such as biopharmaceutical companies, to show that such a template addresses the needs of all single-use stakeholders,' said Kevin Ott, BPSA Executive Director.
'The template will only be effective and widely used if it serves both parties, and we believe our BPSA team of quality professionals from both communities of interest accomplished that task.'
The 2014 BPSA QAT covers compliance requirements, change control, right to audit and resolution of quality issues, among others. It is available for free download and distribution at the website below.
