TAS::75 0872::TAS SMARTT (11-8470187)

如有需要，作为SMARTT指导委员会(SC)和小组委员会的成员参加 为整个Smartt计划提供输入。(第3.0条) 为编制cGMP和GLP级程序手册(MOP)作出贡献，更新如下 在生产阶段(Smartt第二阶段)是必要的。(第2.3.1节) 制定和实施材料转让协议(MTA)，由NHLBI和 CC.(第2.3.2.1节) 为制定评估、确定优先顺序和处理服务请求的程序作出贡献 应用程序(RSA)。(第2.3.2.2节)然后在生产阶段使用这些程序以 评估每个RSA，包括完成可行性评估(FA)。(第2.3.2.3节) 对协调中心(CC)客户满意度调查的设计和内容的贡献 (第2.3.2.5节)、营销计划(第2.3.4节)、公共和私人网站(第2.3.3节)以及 电子数据库，用于跟踪整个生产过程中的所有生物制品和数据。ABL‘s计算机 文中还描述了系统功能。(第4.2条)。 作为美国FDA定义的生物治疗产品cGMP生产工厂提供服务。 生产的产品的加工、分析(第2.3.5节)、储存和运输(第4.1.2节)。 向要求生物治疗的调查人员提供翻译支持或制造服务 产品。(第2.3.5节) 向NHLBI PO和CO提供半年度生产报告(第2.3.2.4节)，同时不断 保持生产非临床和临床产品所需的所有认证和要求； 所有数据均可用于CC每年的现场访问。监测方案的设计与实施 产品，包括生产和遵守监管要求。(第2.3.6节) 维护所有生物制品的质量控制和质量保证计划。(第2.3.6节) 对于每个制造的产品，提供完整的协议信息，包括质量控制和 根据《议定书》的质量保证程序，并准备每批的档案样品 制造的。(第2.3.6节) 在合同的最后几个月有秩序地完成和终止服务协议。 (第2.3.2.6节)

Participation as a member of the SMARTT Steering Committee (SC) and subcommittees as necessary to provide input to the overall SMARTT program. (Section 3.0) Contribution to the creation of a cGMP- and GLP-grade manual of procedures (MOP) with updates as necessary during the production phase (SMARTT Phase II). (Section 2.3.1) Development and implementation of Material Transfer Agreements (MTA) with input from NHLBI and the CC. (Section 2.3.2.1) Contribution to developing procedures for evaluating, prioritizing and processing Request for Services Applications (RSAs). (Section 2.3.2.2) These procedures will then be utilized in the production phase to evaluate each RSA, including completion of a Feasibility Assessment (FA). (Section 2.3.2.3) Contribution to the design and content of the Coordinating Center's (CC) customer satisfaction survey (Section 2.3.2.5), marketing plan (Section 2.3.4), public and private websites (Section 2.3.3), and the electronic database for tracking all biologics and data throughout the production process. ABL's computer system capabilities are also described. (Section 4.2) . Provision of services as a US FDA-defined cGMP production faculty for biological therapy products. Processing, analyzing (Section 2.3 .5), storing, and shipping products (Section 4.1.2) produced. Provision of translational support or manufacturing services to Investigators with requested biological therapy products. (Section 2.3.5) Provision of semi-annual production reports to the NHLBI PO and CO (Section 2.3.2.4), while constantly maintaining all required certifications and requirements to manufacture both nonclinical and clinical products; all data is available for the yearly site visits by the CC. Design and implementation of monitoring plans for products, including production and compliance with regulatory requirements. (Section 2.3.6) Maintenance of quality control and quality assurance plans for all biologics products. (Section 2.3.6) For each manufactured product, provision of complete protocol information, including quality control and quality assurance procedures, in accordance with the MOP, and preparation of archival samples from each lot manufactured. (Section 2.3.6) Provision of orderly closeout and termination of service agreements during the final months of the contract. (Section 2.3.2.6)