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 […]

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 […]

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 […]

Remote Auditing Technology Best Practices and Solutions

January 11, 2021

Auditing to verify a process or system meet stated criteria.  The audit process involves looking for objective evidence that will substantiate that the process or system under review meets the objectives of the quality management […]

Publications

Remote Auditing – A Supplier Perspective

December 8, 2020

Although remote auditing has been in existence for quite a while the practice has become more prevalent and expanded with the recent onset of COVID-19. With public health or other emergencies that could cause risk […]

Rx-360 Technical Visit Guidelines for the Regulated Medical Product Industry Upstream Supply Chain

October 27, 2020

Supplier qualification audits and supplier technical visits are part of routine operations when working in the pharmaceutical or biotech industry.  Many times, technical visits and audits are confused with one another because there is some […]

Rx-360 Supply Chain Security White Paper: Incident Management Version 2.0

The threats of intentional adulteration, cargo theft, counterfeiting, illegal diversion, and tampering are a serious problem in our global marketplace; where criminals are profiting by putting unassuming patients at risk. These threats are product integrity […]

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 […]