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 […]
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 […]
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 […]
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 […]
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.
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 […]