aabb细胞治疗产品标准[第四版].docxVIP

Proposed Standards for Cellular Therapy Standards, 4th edition Introduction The Cellular Therapy Standards Program Unit is soliciting public comment on the proposed Standards for Cellular Therapy Product Services, 4th edition. The summary below presents the most important changes to the proposed CT Standards, 4th edition. Many of the changes are best understood when reviewed in the context of the document. These changes are marked here to assist in your review, but please note that the actual CT Standards is presented without marked changes. To submit comments: Send comments by July 29, 2009 to the Standards Development Department, AABB National Office, 8101 Glenbrook Road, Bethesda, MD 20814; fax (301) 657-0957; email: standards@. Include name and postal address/fax number/email address, as appropriate. Identify the standard by its number at the beginning of the comments. This identification is especially helpful if you comment on more than one standard. Provide alternative wording if you think it would improve the clarity of a standard. If you agree or disagree strongly with a proposed change, please state your reasons or submit data. Significant Changes to the Proposed Standards 1.1.2 Executive Management The facility shall define executive management. Executive management shall have responsibility and authority for the facility’s operations, for appointing a management quality representative, and for performing management reviews. Executive management shall have the authority to establish or make changes to the facility’s quality and operational policies, processes, and procedures. The CT SPU elected to clarify this standard. The change addresses confusion about whether the “management representative” and “quality representative” can be the same individual. Note that the term “quality representative’ is also used later in the section. ?C 2.2.3 Competence Evaluations of competence shall be performed before independent performance of assigned activities and an