4.2.5 Wheredrinking-water is purchased in bulk and transported to the user by watertanker, controls should be put in place to mitigate any risks associatedtherewith. Vendor assessment and authorized certification activities, includingconfirmation of the acceptability of the delivery vehicle, should be ...
The assurance of quality to meet the on -demand expectation of water is therefore essential. 在整个 生产、储存和分配 过程中,应控制水的微生物和化学质量 属性 。化学 检测结果通常可以立即获得,而微生物检测则 因为需要 培养通常被使用之后才能得到 结果 。因此,水的质量 保证 需要满足 其灵活 的使用 ...
However, frequency of testing shouldnot normally be stated in the specification since this is to be established after prequalification based on trend data onseveral batches tested by the FPP manufacturer, and based on the principles of vendor qualification.- FPP生产商的质量标准不应包括周期测试或...
Validation protocol 验证⽅案 4.2. Validation should be executed in accordance with the validation protocol and applicable written procedures.验证应根据验证⽅案和适当的书⾯规程执⾏。4.3. A validation protocol should define the objectives, the validation strategy, including roles and ...
One traditional approach is that cleaning validation is performed and the appropriateness of the cleaning procedure was based on acceptance criteria suggested in GMP texts. This approach may no longer be acceptable and justifiable as HBELs were not considered. ...
a “Points to consider” document be prepared in order to describe the current approaches used in cleaning validation and highlighting the complexities involved in order to establish a common understanding. A revision of the relevant appendix would then be considered by the Expert Committee thereafter...
who验证指南2016年版.docx,1. INTRODUCTION 简介 1.1 Validation is an essential part of good practices including good manufacturing practices (GMP) (4) and good clinical practices (GCP). It is therefore an element of the pharmaceutical quality system. Valid
factoryacceptance test. A testconducted, usually at the vendor’s premises, to verify that the system, equipment or utility, asassembled or partially assembled, meets approved specifications. (new) 工厂验收测试。一种测试,通常在供应商场所进行,以确认组装或部分组装的系统、设备或公用设施是否符合批准的...
4.2.5 Wheredrinking-water is purchased in bulk and transported to the user by watertanker, controls should be put in place to mitigate any risks associatedtherewith. Vendor assessment and authorized certification activities, includingconfirmation of the acceptability of the delivery vehicle, should be ...
transmitted, distributed, translated o r adapted, in part or in whole, in any form or by any means outside these individuals and organizations (including the organizations concerned staff and member organizations) without the permission of the World Health Organization. The draft should not be ...