This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
News|Articles|May 15, 2016
- Pharmaceutical Technology-05-15-2016
- Volume 2016 eBook
- Issue 2
Qualification and Validation of Single-Use Shipping Systems
In this article, the authors look at the limitations of the validation for a single-use shipping system and provide a perspective on what shipping validation means.
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As the biotech industry evolves, there are mounting concerns about the transportation, security, and robustness of cell-culture media, intermediate, or bulk drug substance (BDS). Safe, stable, and closed systems are needed when sterile products are shipped in single-use bags. In this article, the authors look at the limitations of the validation for a single-use shipping system and provide a perspective on what shipping validation means.
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Articles in this issue
over 10 years ago
Measuring and Removing Genotoxic Impuritiesover 10 years ago
Lessons Learned Accelerate Vaccine Developmentover 10 years ago
Protecting the Product and the Patientover 10 years ago
Deconstructing the Regulatory SpiralAdvertisement
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