标准品、工作对品标准管理规程.docVIP

1.目的 本规定了检验分析标准品、对照品基本要求。本适用于检验分析所用标准品、对照品。 QC主管：负责标准品、对照品该人应具有一定药学或分析专业知识，熟悉标准品、对照品的性质和贮存条件。 购买国内购买一般到当地药检所或中检所购买或邮购；国外购买可在当地代理处购 买或直接求购。 标准品、对照品购买单分子式、分子量及结构式 息。 4.3.标准品、对照品接收购回后，检查外包装 、标签完好、清楚。复核与购买单的一致性。准确无误填写记录。内容:标准品、对照品的存期 标准品、对照品贮存期限； 4.4 贮存管理 4.4.1.标准品、对照品一般置于干燥器或冰箱中有序存放，特殊品种应按其规定妥善保存。标准品、对照品用多少取多少，已取出的标准品、对照品严禁倒回原瓶中。填写记录使用和退回标准品对照品剩余标准品、对照品应密封好，方可回并记录。 GMP文件 including incentives) to ensure the achievement of the quality objectives. According to the companys quality system documents, combined with the specific circumstances of the project, preparation of project quality manual, procedures and work related to the project implementation rules to improve the quality management system of the project. A management review meeting held each year, on the implementation of the quality policy, objectives and review of the problems and propose corrective measures. Efforts and resources necessary for optimal allocation of project construction management (personnel, finance, facilities, information, etc). 3.2 with customer focus project staff establish a customer-focused thinking, fully aware that meet their customers needs and expectations is the fundamental pursuit of production and services projects. Projects in production and service processes, to: 3.2.1 identify and determine the needs and expectations of the project legal person, interests as the interests of the customer, with customer satisfaction as satisfied, good faith and cooperation, win-win and development; 3.2.2 needs and expectations of the project legal person into production and service management or technical requirements, and allocation of appropriate resources; 3.2.3 meet legal requirements and strive to exceed their expectations. 3.2.4 customers on the quality of projects put into operation for standards, in accordance with the national standard of quality works. 3.2.5 regulations and standards requires the Sta