Overview
Welcome to the Supplier Quality Working Group
The Supplier-Led Working Group is an Rx-360 working group consisting of members from both pharmaceutical companies and leading suppliers to the pharmaceutical industry. Through this Working Group, both pharmaceutical and supplier members share perspectives and work collaboratively to achieve greater efficiencies in the supply chain and to better serve patients in the long-term.
The Supplier Quality Working Group is currently working on module 5 – single-use systems. We are currently seeking members for this group.
If you are interested in joining this Working Group please contact Michael Cavacini (mcavacini@rx-360.org).
Human Blood Origin Materials for Cell & Gene Therapy Manufacturing Supplier Questionnaire
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.
Natural Disaster Contingency Planning Version 2.0
Rx-360, an International Pharmaceutical Supply Chain Consortium has created this Natural Disaster Contingency Planning guideline in response to natural disasters our members are experiencing. This guideline can serve as a baseline to assist in proactively considering how your organization would internally react in the unfortunate circumstance that a natural disaster impacts one of your business locations.
Rx-360 Guidance and Best Practices for Raw Material Supply Chain Security for Cell and Gene Therapies
Cell and gene therapies (CGT) are novel therapeutic modalities with greater than one thousand clinical trials ongoing globally. The unmet need for treatment options and the promise of these therapies has prompted regulatory agencies world-wide […]