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 […]
Downloadable Supplier Assessment Questionnaire
simplify supplier assessments using Rx-360’s SAQ 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 […]
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 […]
SAQ
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 […]
Quality Elements for Suppliers of Products or Services to GMP Regulated – Spanish Version
Los Elementos de Calidad para los proveedores de productos o servicios que proveen a empresas reguladas por las Buenas Prácticas de Fabricación (BPF); describen los elementos básicos de las buenas prácticas de fabricación (BPF) que […]