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.

Events

Pharmaceutical Supply Chain Security

November 24, 2021

December
6
4 pm UTC+8

On-Demand Webinar
Pharmaceutical Supply Chain Security
In association with
Rx-360
Want to stay in the know of what’s new on the pharmaceutical supply chain security?

Publications

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.

Publications

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 […]

Publications

Rx-360 Responding to the Threat of Illicit Medicines: Methodologies for Monitoring, Investigation & Stakeholder Engagement

March 1, 2021

The distribution and sales of illicit products such as counterfeit, unapproved and diverted medicines are a global concern for pharmaceutical patients, health care professionals, regulators and manufacturers. Counterfeit drugs are not equivalent to the genuine […]

Publications

Rx-360 Understanding the Threat of Illicit Medicines: An Overview of Counterfeit, Tampered, Unapproved and Diverted Pharmaceuticals

The distribution and sales of illicit products such as counterfeit, unapproved and diverted medicines are a global concern for pharmaceutical patients, health care professionals, regulators and manufacturers. Counterfeit drugs are not equivalent to the genuine […]

Templates & Tools

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 […]