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 […]
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 […]
Real Value of Rx-360’s Consortium Membership and Joint Audit Program
Read the 2024 Case Study – showing significant budget relief that came from Rx-360’s programs and consortium membership on a major player in biotech, chemical manufacturing, and life sciences.
Rx-360 Announces Approval as a Pilot Center of Excellence for the APEC Regulatory Harmonization Steering Committee
Rx-360® is pleased to announce that it has been accepted as a Pilot Center of Excellence (CoE) for the APEC Regulatory Harmonization Steering Committee. The pilot will be focused on the Global Medical Product Supply Chain Integrity Priority Work Area Roadmap.