As China continues to evolve its pharmaceutical regulatory landscape, organizations operating within or in partnership with the Chinese market must proactively adapt to remain compliant and competitive. The National Medical Products Administration (NMPA) has outlined […]

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 […]

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 […]

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 web-based Supplier assessment questionnaire is now live 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 […]

The Data Integrity Working Group of Rx-360 members has generated an addendum to the previously issued GMP Audit Manual, Data Governance and Data Integrity which provided an approach for GMP auditing and self-assessment of pharmaceutical […]

Quality Agreements (QAs) have become an essential tool to define quality and regulatory responsibilities between participants of the pharmaceutical supply chain. Especially in regulated environments, QAs form a crucial part of the supplier qualification process. […]

This data integrity audit manual provides an approach for GMP auditing and self-assessment of pharmaceutical manufacturers, contract manufacturers and laboratories for data integrity and data governance elements. The scope includes the manufacture and testing of […]

About: This tool has been developed in excel document: Tab 1: Cause and Effect Matrix Tab 2: Failure Mode and Effects Analysis. Background of Template: The template was designed to compliment the Upstream Supply Chain […]