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April 28, 2014
05:48 EDTPSTIPluristem's manufacturing facility approved by EU auditors for Phase III trials
Pluristem Therapeutics announced that its new manufacturing facility has received the European Union's Qualified Person Declaration. With this declaration, Pluristem is now approved to use cell therapies manufactured at its state-of-the-art facility located in Haifa, Israel, in all phases of its clinical trials conducted in the European Union, including Phase I, Phase II and Phase III. The Qualified Person inspection was conducted in line with the European Union's Good Manufacturing Practice, or GMP, legislation, directives and guidelines. The audit focused on the design, construction and validation of Pluristem's new facility, equipment, utilities, and quality management systems. Pluristem's manufacturing and cell expansion operations were deemed compliant with EU GMP requirements.
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