Wholesale distributors play a pivotal role in safeguarding the integrity of the U.S. pharmaceutical supply chain under the Drug Supply Chain Security Act (DSCSA). The Rx‑360 DSCSA Readiness Checklist for Distributors distills core requirements into […]

Ensuring full compliance with the Drug Supply Chain Security Act (DSCSA) is essential for maintaining product integrity, meeting FDA expectations, and enabling seamless interoperability across the pharmaceutical supply chain. The Rx‑360 DSCSA Readiness Checklist for […]

Optimize Supplier Corrective Actions with Rx‑360’s SCAR Template The Supplier Quality Working Group at Rx‑360 has developed a standardized Supplier Corrective Action Report (SCAR) template designed to strengthen pharmaceutical supply chain integrity and improve quality […]

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 […]