Single-use, change notification: Guidance and implementation tool kit

A BioPhorum and the BioProcess Systems Alliance (BPSA) workstream comprising contributors from 17 drug manufacturers and 12 suppliers has developed a proposed practice to the industry for change notification on single-use systems.

The document looks to align 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 the safe and timely production of medicines. It is anticipated that with widespread adoption of these practices will improve communication up and down the single use supply chain and result in more robust quality systems.

The document is now available on the BioPhorum and BPSA websites.

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CN-Implementation-End-User-letter (3).docx
BPOG-Classification-of-Changes-to-SUS-Proof-05 (1).pdf
An-industry-proposal-for-change-notification-practices.pdf
CN-Implementation-Supplier-letter.docx

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Create Date 26th June 2018
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