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| GMP与质量管理和质量保证系列标准 | |
| 引用本文： | 翁信源,曹凤兰. GMP与质量管理和质量保证系列标准[J]. 中国药房, 1996, 0(3) |
| 作者姓名： | 翁信源 曹凤兰 |
| 作者单位： | 天津市解放军第２５４医院 |
| 摘 要： | ＧＭＰ是医药行业对药品生产质量管理的规范，质量管理和质量保证系列标准（简称ＩＳＯ９０００系列）是国际上物品生产通用的质量管理和质量保证的规范。它们在各自发展基础上互相渗透，互相影响。尤其在１９９２年ＷＨＯ对ＧＭＰ采用了ＩＳＯ９０００系列中的质量保证的措施，因此在医药行业了解ＩＳＯ９０００系列标准更有必要。本文简介了１９９２年ＷＨＯ对ＧＭＰ与ＩＳＯ９０００系列标准的主要内容和一些基本观点。 |
| 关 键 词： | GMP，质量管理，质量保证，ISO9000系列标准 |
GMP and Quality Control and Quality Assurance Serial Standard |
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| Weng Xinyuan, Cao Fengla/. GMP and Quality Control and Quality Assurance Serial Standard[J]. China Pharmacy, 1996, 0(3) | |
| Authors: | Weng Xinyuan Cao Fengla/ |
| Abstract: | GMP is the standard for quality control in drug production. Quality control and quality assurance serial standard (ISO9000) is in common use in the world as the standard of manufacture of products. GMP and ISO9000 interpenetrate and interact each other. The measures of quality assurance in ISO9000 was adopted by WHO GMP in 1992,therefore we should be familiar with ISO9000. This paper briefly presents the content and main points of view of WHO GMP and ISO9000. |
| Keywords: | GMP quality control quality assurance ISO9000 serial standard |
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