... 产品或服务的需求与特性（product or service requirement and characteristic） 产品验收标准（product acceptance criteria） 项目边界（project boundary） ...
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Product acceptance criteria. Defines the process and criteria for accepting completed products.
产品验收准则。产品验收准则确定了验收已完成产品的过程和原则。
Release testing program, including a written standard operating procedure (SOP) detailing the test methods you will use to test each product and the acceptance criteria for each test.
放行检测计划，包括一份书面标准操作规程(SOP)，其中详细说明你们将用于检测每种药品的方法以及每种检测的可接受标准。
Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person (s) authorizing release of product (see 4.2.4).
包含接收准则的符合性证据应加以记录，记录应指明授权产品放行的人员。(见4.2.4)。
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