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Quality management system for a virtual/non-integrated biotechnology company seeking regulatory approval.

机译：虚拟/非集成生物技术公司的质量管理系统，正在寻求监管部门的批准。

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The quality system regulation as described in Part 211 of Title 21 of the Code of Federal Regulations and other guidance and regulatory documents provide the information necessary for an integrated company to determine how to assure the quality, purity, safety and effectiveness of their product. A virtual, non-integrated organization manufacturing through contract manufacturing and seeking to develop their quality system may find that these same documents are deficient. They may be lacking in the detail necessary to ensure an effective quality management system that relies on the quality system of contract manufacturing organizations. The standard operating procedure that has been developed as a result of this project is designed to provide a quality management system that will assure that the quality system of the sponsor is aligned and integrated with the quality system of the contract manufacturing operations that support the sponsor's product.

机译：如《联邦法规》第21篇第211部分所述的质量体系法规以及其他指南和法规文件，为一家综合公司确定如何确保其产品的质量，纯度，安全性和有效性提供了必要的信息。一个虚拟的，非集成的组织通过合同制造进行制造，并试图开发其质量体系，可能会发现这些相同的文档不足。他们可能缺少必要的细节，无法确保有效的质量管理体系依赖于合同制造组织的质量体系。由于该项目而制定的标准操作程序旨在提供质量管理体系，以确保赞助商的质量体系与支持赞助商产品的合同制造运营的质量体系保持一致和整合。。

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作者
Wilson, Beverly R.;
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作者单位

California State University, Dominguez Hills.;

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授予单位 California State University, Dominguez Hills.;
学科 Health Sciences Pharmacology.
学位 M.S.
年度 2005
页码 38 p.
总页数 38
原文格式 PDF
正文语种 eng
中图分类药理学;
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5. Designing quality system organization in a newly started biotechnology company. [D] . Hosseini, Minoo. 2004

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7. Proposal for a Council Decision on the recognition of the British Standard BS7750: 1994, establishing specification for environmental management systems, in accordance with article 12 of the Council Regulation (EEC) N. 1836/93 of 29 June 1993, allowing voluntary participation by companies in the industrial sector in a community eco-management and audit scheme; Proposal for a Council Decision on the recognition of Irish Standard IS310: First Edition, establishing specification for environmental management systems, in accordance with Article 12 of the Council Regulation (EEC) N. 1836/93 of 29 June 1993, allowing voluntary participation by companies in the industrial sector in a community eco-management and audit scheme; Proposal for a Council Decision on the recognition of Spanish Standard UNE77-801(2)-94: , establishing specification for environmental management systems, in accordance with Article 12 of the Council Regulation (EEC) N. 1836/93 of 29 June 1993, allowing voluntary participation by companies in the industrial sector in a community eco-management and audit scheme (presented by the Commission). COM (95) 422 final, 27 September 1995 [O] . 1995

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Quality management system for a virtual/non-integrated biotechnology company seeking regulatory approval.

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