Managing Critical Vendors Version 2.0
The manufacture of medical products, drugs and devices is highly regulated all over the world. All aspects of the manufacturing process, from product design to product delivery, require documented procedures. Key points in the process […]
Quality Elements for Suppliers of Products or Services to GMP Regulated Companies
Medical products are items used to diagnose, treat, cure, mitigate or prevent disease in patients. These include pharmaceutical products and medical devices. The manufacture of medical products that are used in the United States, and […]
Good Distribution & Warehouse Practices for Warehouse & Transportation Suppliers in LATAM
The warehousing and distribution of regulated medical products is a very important part of the supply chain from manufacturer to the patient. Various separate entities are responsible for the storage and shipping of these products […]
Selection and GMP Auditing of Software and Hardware Vendors
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 […]
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 […]
Human Blood Origin Materials for Cell & Gene Therapy Manufacturing Supplier Questionnaire
Materials derived from human blood such as human serum albumin and transferrin are frequently used either as components of cell culture medium or in other processes. Suppliers of such reagents have incorporated multiple mitigation steps such as sourcing pharmaceutical grade or licensed drug product, sourcing from safe geographical regions, testing for contaminants and inactivation. In addition, this information needs to be available for review during inspections and in regulatory filings. This questionnaire is a comprehensive list of those requirements and will be a useful document for reference.
Pharmaceutical Supply Chain Security
December
6
4 pm UTC+8
On-Demand Webinar
Pharmaceutical Supply Chain Security
In association with
Rx-360
Want to stay in the know of what’s new on the pharmaceutical supply chain security?
Natural Disaster Contingency Planning Version 2.0
Rx-360, an International Pharmaceutical Supply Chain Consortium has created this Natural Disaster Contingency Planning guideline in response to natural disasters our members are experiencing. This guideline can serve as a baseline to assist in proactively considering how your organization would internally react in the unfortunate circumstance that a natural disaster impacts one of your business locations.