Cell Therapy: cGMP Facilities and Manufacturing is the source for a complete discussion of facility design and operation with practical approaches to a variety of day-to-day activities, such as staff training and competency, cleaning procedures, and environmental monitoring. This in-depth book also includes detailed reviews of quality, the framework of regulations, and professional standards. It meets a previously unmet need for a thorough facility-focused resource, Cell Therapy: cGMP Facilities and Manufacturing will be an important addition to the cell therapy professionalas library. Additional topics in Cell Therapy: cGMP Facilities and Manufacturing...Standard operating procedures - Supply management - Facility equipment - Product manufacturing, review, release and administration - Facility master file.Bethesda, MD: AABB. Brecher, M.E., ed. 2005. Technical Manual, 15th edition, p. 22. Bethesda, MD: AABB. Badley, J. K. 2004. Do You Have Any Plans? In Introducing the Big Q: A Practical Quality Primer, L. M. Walters, ed., p. 100. Bethesdaanbsp;...
|Publisher||:||Springer Science & Business Media - 2009-09-18|