Developing A Quality Agreement Template For Single-Use Systems - Pharmaceutical Technology

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PharmTech Europe

Developing A Quality Agreement Template For Single-Use Systems

Pharmaceutical Technology Europe
Volume 22, Issue 10

Progress to date

At the moment, the BPSA QATTF is comparing existing templates and will be creating subsections to the document that cover the key points that the QAT must have. Some of the issues to be addressed will be identification of critical changes, change control and notification, subcomponent supplier qualification, component origin information, customer involvement in changes to standard products, levels of disclosure and custom product quality specifications. Rather than hinder uptake, we envision the BPSA QAT will provide higher assurance of quality supply and facilitate faster uptake of singleuse equipment by reducing the time, cost and effort to establish agreements.

The BPSA QATTF had its first meeting on 12 August 2010. The task group is currently defining a process for developing the document, which is expected to be completed over the next 4–6 months. This template will be another tool that biopharmaceutical companies and suppliers can use to ensure that high quality, safe drug and vaccine products can be delivered to patients at the time they are needed, to save and improve the quality of peoples' lives. Interested parties are invited to contact the BPSA for corporate membership and participation information.

Based on preliminary feedback from singleuse suppliers and users, we anticipate that, when published, the impact of the BPSA QAT will be positive. Smaller companies are more likely to accept it as offered while larger companies are likely to demand customisation, but the consensus is that the BPSA QAT will facilitate the finalisation of agreements in a more expedient manner. We predict that requests for quality agreements will increase as regulatory agencies come to expect these to be in place between users and suppliers of singleuse process equipment.

For further information about the BPSA's publications and activities, please visit


With thanks to Todd Kapp of Renolit, Jamie Ethier of Millipore, Ann Rich of ThermoFisher, and Terry Cusick of Pall for their valuable input.

Jerold Martin is Senior Vice President, Global Scientific Affairs, Biopharmaceuticals at Pall Life Sciences and Chairman of the Board, Bio-Process Systems Alliance.


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