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基本説明
細胞療法プロダクトサービスに関する定評のあるマニュアル。
Publication of the American Association of Blood Banks.
Full Description
Cellular therapy product services have long been required to write and maintain 'procedures manuals' containing documents that have described the service's technical work activities. These manuals do not always describe how to conduct essential nontechnical work required by the current good tissue practice (cGTP) regulations and the AABB Standards for Cellular Therapy Product Services. The "CT Quality Manual Workbook" remedies this oversight. This workbook provides guidance for writing policies for the Quality System Essentials (QSEs) and identifying the processes and procedures needed to complete a quality manual. It includes templates for QSE policies that address all requirements from the first edition of the AABB CT Standards.
The highlights inclde: answers to the most commonly asked questions about a quality manual; templates for policies for each of the cellular therapy product services QSEs, both in print and electronically captured on a CD that can be used to develop a cellular therapy product service quality manual; a list of processes - both technical and nontechnical - that support the CT Standards and QSEs Comparisons of the QSEs to the recently finalized cGTP regulations and the FACT standards.
