Industry proposal for change notification in single use systems
A BPOG and the BioProcess Systems Alliance (BPSA) workstream comprising contributors from 17 drug manufacturers and 12 suppliers has been working on a proposed practice to the industry.
The document looks to support aligning all parties to a change notification process, clarifying roles and responsibilities, facilitating communication and process standardization.
Implementation of this practice will support companies and regulators to ensure safe medicines. It is also anticipated that widespread adoption of this practice will improve communication and education of suppliers and manufacturers and result in more robust quality systems.
The document is now available on the BPOG and BPSA websites. Click on the link to access it here.