WHY IS A QUALITY AGREEMENT TEMPLATE NEEDED?
One of the major challenges with quality agreements that users and suppliers have experienced is that no two companies request
the same information, resulting in many hours spent filling out and modifying each company's unique forms. Singleuse system
suppliers are considered more responsible for the user's processes than stainless steel component or system suppliers because
singleuse components could conceivably vary from lot to lot, with users being highly dependent on the quality and delivery
(and repeat quality) of such systems. Consequently, users are requesting to be kept more informed of supplier process changes
beyond what has been previously acceptable practice. Singleuse equipment suppliers and users must find ways to ensure suitable
change notification on custom-assembled systems for users, while enabling sufficient flexibility of suppliers for updating
standard products and processes. Based on a BPSA informal survey of singleuse supplier QA managers, the BPSA estimates that 60–70% of the work undertaken to establish agreements between supplier and user is redundant and does not serve any added
Adoption of singleuse technologies for biopharmaceutical manufacturing is growing every day, and many user and supplier companies
have expressed the need for an easier way to execute quality agreements in a more timely and lowcost manner. By streamlining
the process, the adoption of single-use technologies can progress more efficiently and rapidly, with a higher sense of process
consistency and product quality, at lower cost. The BPSA has already helped the industry significantly by educating and providing
best-practice guides for the adoption of singleuse technologies. BPSA documents such as extractables/leachables guides, white
papers on component quality test methods, irradiation/sterilization, disposal, and the economic advantages of singleuse are
good examples of what the BPSA has been able to accomplish in a relatively short period of time.
The BPSA QAT will be a consensus document that identifies commonalities of various templates existing today and will be more
effective as a starting point for negotiations. Application of the BPSA QAT will be voluntary (as a trade association, BPSA
has no mandate authority).
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 has been working to define 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
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
customization, but the consensus is that the BPSA QAT will facilitate the finalization of agreements in a more expedient manner.
Requests for quality agreements are likely to increase as regulatory agencies come to expect these to be in place between
users and suppliers of singleuse process equipment.
With thanks to Todd Kapp of Renolit, Jamie Ethier of Millipore, Ann Rich of ThermoFisher, and Terry Cusick of Pall for their
For further information about BPSA's publications and activities, please visit
JEROLD MARTIN is senior vice-president for Global Scientific Affairs, Biopharmaceuticals, at Pall Life Sciences and chairman of the board
for Bio-Process Systems Alliance (BPSA), firstname.lastname@example.org
1. pharmtech.findpharma.compharmtech/survey/surveyList.jsp?id=683202, accessed Aug. 2011.