参考资料: [1] Immel B K. A brief history of the GMPs for pharmaceuticals[J]. Pharmaceutical technology, 2001, 25(7): 44-53. [2]https://www.theatlantic.com/technology/archive/2018/01/the-accidental-poison-that-fo...
No. The CGMP regulations neither approve nor prohibit specific equipment for use in manufacturing of pharmaceutical products (with the exception of asbestos and fiber-releasing filters, see 21 CFR 211.72).? We do not maintain a list of appr...
1969年第22届世界卫生大会WHO建议各成员国的药品生产采用GMP制度,以确保药品质量和参加“国际贸易药品质量签证体制” (Certificate-ion Scheme On the Quality Of Pharmaceutical Products Moving in International Commerce,简称签证体制)。
提升无菌药品生产质量管理水平CONTENTS目录CHAPTER01药品GMP概述与重要性药品GMP定义及目标药品GMP定义药品GMP目标药品GMP(GoodManufacturingPracticeforPharmaceuticalProducts)是指药品生产质量管理规范,它是一套适用于药品生产企业的强制性标准,要求企业从原料、人员、设施设备、生产过程、包装运输、质量控制等方面按国家有关法规...
该概念更早源于2014年8月医药保健科学学会(Pharmaceutical and Healthcare Scie⁃nces Society,PHSS)发布的《无菌药品生产控制策略白皮书》(Control Strategy White Paper⁃In manufactu⁃ring of Sterile Pharmaceutical/Drug Products)[9]。白皮书阐述了无菌药品生产、质量和污染控制策略相关要求。2017年欧盟修订的附录...
该概念更早源于2014年8月医药保健科学学会(Pharmaceutical and Healthcare Sciences Society,PHSS)发布的《无菌药品生产控制策略白皮书》(Control Strategy White Paper⁃In manufacturing of Sterile Pharmaceutical/Drug Products)[9]。白皮书阐述了无菌药品生产、质量和污染控制策略相关要求。2017年欧盟修订的附录1征求意见...
Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles 附录2 WHO药品GMP:主要原则 Introduction引言 General considerations总则 Glossary术语 Quality management in the medicines industry: philosophy and essential elements 制药企业的质量管理:GMP 理念和基本元素 1. Pharmaceutical quality...
3.2 Although the focus is on medicinal (pharmaceutical) products, some of the principles may be applied to other investigational products. 尽管重点放在医药产品(药品)上,但某些原则可能适用于其他研究性产品。 4. Quality management 质量管理 4.1 There should be a comprehensively designed, clearly defined,...
2.1 The manufacture of sterile products is subject to special requirements in order to minimize risks of microbial, particulate and endotoxin/pyrogen contamination. The following key areas should be considered: 无菌产品的制造须遵守特定要求,以尽量减少微生物、微粒和内毒素/热原污染的风险。应考虑以下关键领...
In response to this need, the Chinese government has issued the Chinese GMP, which outlines the requirements for the manufacturing of pharmaceutical products. Facility Design Equipment Validation Process Controls 第三篇示例: GMP是Good Manufacturing Practice的简称,是指良好生产规范。GMP是一套通过设立相关...