Current practices surrounding change notification in the biopharmaceutical industry are neither efficient nor conducive to accelerating the adoption of single-use systems.
From a drug manufacturer’s perspective, it is common to observe that change data packages are lacking in technical content or detail, and that the time allowed for change implementation is too short. Occasionally, changes are learned of after the fact, possibly even by happenstance.
From a supplier’s perspective, it is difficult to understand the potential impact of a change on a customer: the end user’s regulatory environment is not always transparent to the supplier; how drug manufacturers use
These observations may be
– End users explicitly inform suppliers of their regulatory, business, and technical drivers/expectations related to change notification, and the ways in which the supplier’s products are being used.
– Suppliers likewise are required to document changes and communicate notifiable changes clearly, promptly, and with technical rigor.
Aligning all parties to a change notification process, to definitions of terms, and to clarified roles and responsibilities would greatly facilitate communication and process standardization across the industry. This is the ongoing mission of the BPOG/BPSA change notification workstream and publication of this whitepaper is a key milestone. The workstream will now be focusing on how these principles can be effectively implemented and derive benefit against the backdrop of existing practices and systems.