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Developing a quality agreement template for single-use systems.
Single-use systems are being used more and more in manufacturing. The time savings, reduced incidence of cross-contamination, reduced need for cleaning, and increased overall efficiency, to name a few advantages, make these technologies a very attractive proposition for manufacturers. There are, however, several obstacles to implementing the single-use systems; a key obstacle being manufacturers' unwillingness to replace fully installed and validated technologies, while the lack of clarity in understanding the regulatory requirements for single-use technology presents another barrier.
Notwithstanding the potential hurdles, a recent poll of Pharmaceutical Technology readers confirmed that the majority of companies (56%) are already using single-use technologies. Of the remaining respondents, 18% admitted that they planned to use single-use technology in the future (1). So it is clear that, not only is single-use here to stay, but it could fully replace certain stainless-steel technologies in the future.
The development of quality agreements between biopharmaceutical companies and contract manufacturers has long been recognized as a critical activity to ensure that a product's quality meets regulatory requirements. Quality agreements are used to clearly establish each party's responsibilities and assure that manufacturing processes are controlled according to mutual understanding. For outsourced biological products, this is supported by the 2008 FDA Guidance, Cooperative Manufacturing Arrangements for Licensed Biologics. More recently, biopharmaceutical companies have looked to establish quality agreements with raw material and API suppliers as a means to guard the supply chain from counterfeit or adulterated materials. This drive has led to the recent publication of a Quality Agreement Template for API manufacturers by the Bulk Pharmaceutical Task Force (BPTF), an affiliate of the Society for Chemical Manufacturers and Affiliates (SOCMA).
Considering the increased reliance that singleuse manufacturing technology places on suppliers to ensure biopharmaceutical quality, quality agreements have also begun to be established between singleuse process equipment suppliers and users—particularly for critical singleuse equipment, such as filters, biocontainers, tubing manifolds, and other integrated singleuse systems. While some companies have negotiated agreements on a casebycase basis, there is a recognized need within the industry for a common quality agreement template (QAT) specific to single-use manufacturing that highlights key performance criteria. With this in mind, the BioProcess Systems Alliance (BPSA), also an affiliate of SOCMA, has formed a Quality Agreement Template Task Force (QATTF) to develop a suitable template for singleuse technologies for the benefit of users and suppliers.
BPSA is an industry trade organization for suppliers and users of singleuse technologies for production of biopharmaceuticals and vaccines. Its primary objective is to facilitate the implementation of singleuse manufacturing through networking, recognition, and publication of best-practice guides, to provide clarification of current regulatory requirements, and to interact with governmental agencies on emerging issues that may impact BPSA members. The BPSA QATTF is composed of quality department personnel from member companies that are system suppliers and end users. This is a global initiative because many BPSA member participants on the committee represent global companies.
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 value.
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).
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 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 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 valuable input.
For further information about BPSA's publications and activities, please visit www.bpsalliance.org.
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.