Publications

Human Blood Origin Materials for Cell & Gene Therapy Manufacturing Supplier Questionnaire

May 24, 2022

Materials derived from human blood such as human serum albumin and transferrin are frequently used either as components of cell culture medium or in other processes. Suppliers of such reagents have incorporated multiple mitigation steps such as sourcing pharmaceutical grade or licensed drug product, sourcing from safe geographical regions, testing for contaminants and inactivation. In addition, this information needs to be available for review during inspections and in regulatory filings. This questionnaire is a comprehensive list of those requirements and will be a useful document for reference.

Rx-360 Insights

Rx-360 Supplier Assessment Questionnaire Team Publishes Module 6 – Single Use Bioprocessing Product Questionnaire

May 5, 2021

The Rx-360 Supplier Assessment Questionnaire (SAQ) team, a sub-committee of the Rx-360 Supplier Quality Working Group (SQWG), is very pleased to announce the release of the newest module of the Supplier Assessment Questionnaire Kit: Module […]

Publications

Supplier Assessment Questionnaire

January 19, 2021

Background on Supplier Assessment Questionnaire Pharmaceutical manufacturers and industry suppliers recognize the inefficiency and waste of resources when each individual pharmaceutical company creates its own supplier assessment questionnaire. Suppliers routinely exhaust valuable resources continuously completing […]