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 […]
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 […]
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 Selection and GMP Auditing of Software and Hardware Vendors
Your computerized systems are only as compliant as the vendors behind them. Explore best practices for assessing software and hardware suppliers, evaluating quality systems, conducting GMP audits, and ensuring data integrity throughout the system lifecycle.
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.
Rx-360 Guidance and Best Practices for Raw Material Supply Chain Security for Cell and Gene Therapies
Cell and gene therapies (CGT) are novel therapeutic modalities with greater than one thousand clinical trials ongoing globally. The unmet need for treatment options and the promise of these therapies has prompted regulatory agencies world-wide […]
Rx-360 Responding to the Threat of Illicit Medicines: Methodologies for Monitoring, Investigation & Stakeholder Engagement
The distribution and sales of illicit products such as counterfeit, unapproved and diverted medicines are a global concern for pharmaceutical patients, health care professionals, regulators and manufacturers. Counterfeit drugs are not equivalent to the genuine […]
Rx-360 Understanding the Threat of Illicit Medicines: An Overview of Counterfeit, Tampered, Unapproved and Diverted Pharmaceuticals
The distribution and sales of illicit products such as counterfeit, unapproved and diverted medicines are a global concern for pharmaceutical patients, health care professionals, regulators and manufacturers. Counterfeit drugs are not equivalent to the genuine […]