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来源：百度知道 编辑：UC知道 时间：2024/05/22 15:21:04
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GMP及药剂设备验证教学资料编辑
摘 要
GMP全称Good Manufacturing Practice，药品生产质量管理规范。GMP验证范围包括人员、厂房与设施、设备、卫生、文件、生产管理、质量管理等制药过程的方方面面。其中，作为药品制造设备的制药机械是决定药品质量的关键因素。制药机械能否符合GMP规定，是制药机械立足制药行业的生死关键，也是药机发展的方向。但目前中国的GMP（1998版）只对制药设备的GMP提出了总体的要求，并没有具体到具体的设备，没有根据不同设备的原理提出设计要求和验证方案。本文搜集整理了企业中具体制药设备的设计要点和验证方案进行了编辑整理，作为设计和验证实例为同学学习GMP课程提供参考。
本文主要介绍了四种典型药剂设备的符合GMP要求的设计要点，随后整理了这四种典型药剂设备的验证方案，这些验证方案均来自药剂厂和药厂的验证实例，通过典型药剂设备符合GMP要求的设计要点和验证方案的编辑整理作为GMP及药剂设备验证课程的补充资料。

GMP and medicine apparatus verify a teaching materials editor
Summary:
GMP full name Good Manufacturing Practice, the standardard management of quality of production of medicines. GMP proves the range includes every aspect of pharmacy course such as personnel, factory building, facility, apparatus, hygiene, file, production management, quality control. Among them, as pharmacy machinery of making the apparatus of medicines being the key factor to determine quality of medicines. Pharmacy machinery could accord with GMP regulation, it is pharmacy machinery that base on pharmacy key of life and death of trade, it is a direction of development of medicine machine too. But GMP (1998 edition) of China has put forward the total requirement only to GMP of the apparatus of pharmacy at present, the concrete apparatus arrives specifically, the principle of different apparatus without good grounds proposes the designing requirement and verifies the scheme. This text collect, put in ord