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Cargo Security Risk Assessment and Planning for Global Operations
This whitepaper provides an overview of industry best practices for developing and implementing an effective conveyance
security program regardless of company size or prior experience with supply chain security issues.
Cargo Security Risk Assessment and Planning for Global Operations
This whitepaper provides an overview of industry best practices for developing and implementing an effective conveyance security program regardless of company size or prior experience with supply chain security issues.
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- Guide to Investigations – A Collaborative Publication by the Rx-360 Latin America Working Group
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- Supplier Assessment Questionnaire
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Rx-360 Best Practices for Quality Agreements Version 2.0
Transition of ISO 13485 2003 to 2016
ISO 13485 is an internationally recognized quality management standard for organizations involved in the development, manufacture and distribution of medical devices. The standard was first published in 1996. It was updated in 2003 and again […]
Taking a Collaborative Approach to Secure Donated Medicines
Providing and receiving donated medicines to populations in need through NGO partners can serve as a tremendous benefit to patients who may not otherwise be able to receive them by way of conventional means. Unfortunately, […]
Guide: Best Practices for Quality Agreements Version 2.0
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. […]
GMP Audit Manual – Data Governance and Data Integrity
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 […]
Integrating a Third Party Audit Provider into an Existing Supplier Quality Management Process
The increase in requirements and expectations from both Regulators and Customers has challenged the Pharmaceutical Industry to maintain sufficient oversite of their Supplier Management Programs. Suppliers as well are being asked to host more customer […]
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 […]
Rx-360 Quality Elements for Suppliers of Products or Services to GMP Regulated Companies
Quality Elements for Suppliers of Products or Services to GMP Regulated Companies outlines the basic GMP elements expected of suppliers whose products or services eventually enter the supply chain for commercial manufacturing and delivery of […]