Pharmaceutical Technology-05-15-2016

Electrophilic and other reactive compounds, and their precursors, must be measured and removed to ensure patient safety.

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.

This article examines the changes now taking place, and what the future might bring.

Revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones.

Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing

Intact enables aseptic filling in non-classified environments, maintains sterility throughout the process, and reduces costs, timelines, and contamination risks.

Erring on the side of safety is a well-established way of ensuring patient safety, but it may now be getting out of hand, as product recalls and withdrawls deprive patients of necessary treatments without the surety that recalled product would have caused any harm to the patient.

This article discusses the issue and offers food for thought and suggestions for more science-driven approaches.