Drugmakers are about to be assigned greater responsibility for the in-transit portion of their finished products' supply chain expedition. A proposed revision to US Pharmacopeia section 1079, "Good Storage and Transportation Practices for Drug Products," maps the multi-handoff pathway from manufacturer to end user and reassesses it as a global, rather than regional, trek.
The draft revision, now out for comment, ups the ante to strategic planning from the tactical recommendations established in 2006, reports Pharmaceutical Commerce magazine. The update pushes manufacturers towards systems-level thinking: quality management systems for both storage and transportation, and environmental management requirements encompassing temperature monitoring devices and standard operating procedures. And it recommends a risk management system for assessing temperature excursions and other sources of product damage.
The public review runs through March. Completion is expected by end of year.