By Ellen Leinfuss, SVP and Life Science practice leader, UL EduNeering
At the PDA Quality Metrics Conference in December 2013, FDA CDER (Center for Drug Evaluation and Research) Director Janet Woodcock set out her goals for the conference: “to shift [the FDA’s] focus to performance and away from compliance.” Under the FDA’s lead, the life sciences community will have no choice but to follow suit in its own operations and approaches to quality.
By Gary Partington, Walker Barrier Systems
If you are considering purchasing one, here are five questions to answer that will help you prepare before contacting or working with a containment system vendor.
By Kevin Lee, DPT Laboratories
With the increased globalization and accompanying complexity of the pharmaceutical supply chain, managing the role of materials sourcing has become extremely challenging. Reducing time and costs are important goals of sourcing, but increased regulations and more rigorous enforcement make these goals difficult to achieve.
By Sean Birch, Applications Engineer, Lighthouse Worldwide Solutions
Cleanroom Classification and class limits are established in ISO 14644-1, while specifications for testing and monitoring to prove continued compliance are established in ISO 14644-2.
By Stephen E. Szabo, Ph.D. and Sarah Monroe, B.S., Beckman Coulter, Inc.
Stem cells, due to their differentiation into mature blood cells, are the key to successful bone marrow transplantations. More recently, it has been found that umbilical cord blood is also a plentiful and rich source of hematopoietic stem cells.