Change notification is an important aspect of biopharmaceutical manufacture. It is part of ensuring that the drug manufacturers have control of their processes, are aware of, and can respond to, changes that may impact their product so as not to adversely effect product quality or supply. At the same time suppliers need to be aware of the impact necessary changes may bring, how they can support end users and manage necessary changes smoothly. Typically those suppliers working directly with end users (tier one suppliers) will also have an extended supply chain and it is also important to manage change notification consistently with these suppliers, and indeed throughout the extended supply chain

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 supplier data can also be unknown or misunderstood by the supplier, and; drug manufacturers do not have a uniform set of needs and expectations.

These observations may be attributed to industry-wide deficiencies in communication and process standardization. Communication requires that:

– 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.

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