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
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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.
Virtual European Biomanufacturing Summit
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 […]
Remote Auditing Technology Best Practices and Solutions
Auditing to verify a process or system meet stated criteria. The audit process involves looking for objective evidence that will substantiate that the process or system under review meets the objectives of the quality management […]