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Rx-360 Best Practices Quality Agreement Guide
This Best Practices Quality Agreement Guide is intended to assist both Customers and Suppliers in efficiently managing the initiation, negotiation, implementation, and ongoing maintenance of quality agreements. “Supplier” is used broadly in this document to […]
Rx-360 Best Practices Quality Agreement Guide
This Best Practices Quality Agreement Guide is intended to assist both Customers and Suppliers in efficiently managing the initiation, negotiation, implementation, and ongoing maintenance of quality agreements. “Supplier” is used broadly in this document to […]
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- Supplier Assessment Questionnaire
- Rx-360 Remote Audit Best Practice Guide
- Remote Auditing – A Supplier Perspective
- Remote Auditing Technology Best Practices and Solutions
- Rx-360 Understanding the Threat of Illicit Medicines: An Overview of Counterfeit, Tampered, Unapproved and Diverted Pharmaceuticals
- Selection and GMP Auditing of Software and Hardware Vendors
Taking a Collaborative Approach to Secure Donated Medicines
Rx-360 Supplier Assessment Questionnaire 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 […]