Prevention of Reuse of Genuine Packaging Components for Counterfeit Products
“Prevention of Reuse of Genuine Packaging Components for Counterfeit Products” addresses the growing threat of counterfeit pharmaceutical products entering the legitimate supply chain through the reuse of genuine packaging components. Counterfeiters often retrieve discarded packaging—such […]
Supplier Readiness Checklist
Use Rx-360’s Supplier Readiness Checklist to ensure that you – the supplier – meet the operational, quality, and compliance standards required industry-leading global pharmaceutical manufacturers. Developed from an industry-leading global pharmaceutical manufacturer’s supplier management standard […]
Direct-to-Patient Pharmaceutical Programs
The pharmaceutical landscape is evolving rapidly, and one of the most transformative shifts is the rise of direct-to-patient (D2P) distribution. As manufacturers seek to bypass traditional channels and deliver medications straight to patients’ doors, the […]
Rx-360 Technical Visit Guidelines for the Biopharmaceutical Industry
Get guidance from subject matter experts on the requirements, execution, and management of the “technical visit”, as a tool in the supplier quality manager’s toolbox, and as it compares to the “quality audit”. The publication […]
The Life of an Rx-360 Auditor by Kristen Hedrick
Clarifying QMS Relevancy: Why We Need Industry Guidance Now
In the world of regulated industries—Quality Management Systems (QMS) are the backbone of consistent, safe, and effective operations. But here’s the catch: the language in ISO and other standards often leaves too much room for […]
SCAR – Supplier Corrective Action Report Programs: A Practical Guide Developed by the Supplier Quality Working Group
‘SCAR’ gives pharmaceutical industry professionals a framework for handling improvements that they demand from their suppliers (i.e., vendors) based on regulations and/or the outsourcing entity’s own quality standards. This guide includes a template SCAR form […]
Patient Safety Blog – How to Plan for the Unplannable
Life sciences and healthcare organizations must have comprehensive risk management and crisis management plans that can provide for proactive risk scenario planning and a rapid response to supply chain emergencies. They also need to develop […]
What We Read
Decision making might be tougher now than it has been for most of our careers. Today, we all have unprecedented needs for reliable info sources. “Grassroots” style info sharing is proving to be a critical […]