Publications

Rx-360 Remote Audit Best Practice Guide

August 28, 2020

Rx-360 through our Member Consortium has developed a Version 1.0 Best Practice Guide for Remote Auditing. This initial version will present a foundation on best practices that the Rx-360 membership have utilized and observed as […]

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.

Natural Disaster Contingency Planning Version 2.0

October 5, 2021

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

May 13, 2021

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 […]