Titlebook: Cell Therapy; cGMP Facilities and Adrian Gee Book 2009 Springer-Verlag US 2009 cancer.cell.gene.gene therapy.genes.regulation.research.ste

贪婪的人

harpsichord

和谐

AABB Cell Therapy Standards and the events leading up to the need to regulate these activities. It will also explore how the quality management system approach to regulatory compliance has been applied to the development of the AABB cell therapy standards and accreditation program.

知道

Standard Operating Proceduresor tenet of GMP/GTP is “if an activity was not documented, it was not done.” Both quality oversight and documentation are largely facilitated by use of Standard Operating Procedures (SOPs). This chapter reviews the structure and development of SOPs.