By: GE Healthcare
Single-use equipment may be strategically adopted by biopharmaceutical manufacturers as a means by which to accelerate time to market, thereby serving patients more effectively and gaining a greater return on investment. Adoption of single-use equipment represents a shift in the responsibilities between supplier and end-user with respect to managing critical quality attributes.
Among these quality attributes are extractables/leachables, sterility assurance, integrity/leak assurance, and particulate load. Regulators across the globe have taken various approaches to lending guidance, either maintaining that today’s regulations and guidance are fully applicable to any modality of manufacturing (multi- or single-use), or deciding to embark on guidance intended to coalesce todays best practices.
Relative to multi-use equipment, a large fraction of this responsibility shifts to the suppliers. On the other hand, the end-user still retains full accountability for assuring that the single-use equipment is suitable for use and is being appropriately managed from a quality perspective. This shift in responsibility and the attendant regulatory challenges may cause hesitation on the part of the end-user as one works through development of control strategies that, by their nature, include an important element of reliance on the supplier’s quality management.
GE Healthcare views the current state of the biopharmaceutical manufacturing industry as an opportunity to provide insights that delineate the differences between multi- and single-use equipment. In addition, sharing best practices of how supplier and end-user responsibilities must evolve are critical to ensure effective quality management of single-use equipment for biopharmaceutical manufacturing.