1.1 Thisdocument concerns water for pharmaceutical use (WPU) produced, stored anddistributed in bulk form. It intends to provide informationabout different specifications for WPU; guidance on GMP regarding the qualitymanagement of water systems;water treatment(production) systems; waterstorage and distribu...
7.29.If it becomes necessary to change theuse-by date, an additional label should be affixed to the investigationalmedicinal product. This additional label should state the new use-by date andrepeat the batch number. This labelling activity should be performed inaccordance with GMPprinciples, standa...
2.4. These products are sometimes not covered by legal and regulatory provisions in the areas of good practices (GxP) and inspection. These complexities, such as lack of high level good manufacturing practices (GMP) requirements, risk of contamination and cross- contamination, clinical trial designs...
11.4. Where activities are outsourced tocontract facilities, the contract must then clearly state, inter alia, theresponsibilities of each party, compliance with GMP or of this guideline, andthat the product(s) to be manufactured or controlled are intended for use inclinical trials. Close cooperat...
WHO《临床试验用药品 GMP 指南》中英文对照版 WHO 发布的 Working document QAS/20.863 《临床试验用药 GMP 指南》,该文件翻译如下,供大家参考:Good manufacturing practices for investigational products 临床试验用药品 GMP 指南 1. Background 背景 1.1. In view of an old publication date,and the recent need...
11 月 5 日,世界卫生组织(WHO)发布了“试验用药品GMP” 指南(Good manufacturing practices for investigational products)的征求意见稿。 该文件是对WHO GMP附录7的修订,目前正处于收集意见期,截止日期为2021年1月。此后,将于2021年2-3月份提交专家工...
近日,WHO发布了Working document QAS/20.863 《临床试验用药GMP指南》,该文件翻译如下,供大家参考: Good manufacturing practices for investigational products 临床试验用药品 GMP 指南 1.Background背景 1.1.In view of an old publication date,and the recent need for new guidelines arising from inspections carrie...
Documented evidence that, for example, the premises, supporting systems, utilities, equipment and processes have been designed in accordance with the requirements of good manufacturing practices (GMP). 设计确认 书面证据,例如,设施、支持系统、公用系统、设备和工艺是根据良好生产规范(GMP)的要求设计的。
近日,WHO发布了 《制药用水GMP指南》,该指南英文全文29页,包含以下内容: 制药用水系统的一般原则 饮用水、纯化水、高纯水、注射用水和其他级别的水的质量标准要求 制水系统、储存和分配系统的注意事项 水系统良好规范 系统消毒与生物污染控制 储罐的要求 ...
1.2. The objective of this update is tobring the guideline in line with current expectations and trends in goodmanufacturing practices and to harmonize the text with the principles fromother related international guidelines. 本次更...