They havebeen aligned as far as possible with the terminology in related WHO guidelinesand Good Practices and included in the WHO QualityAssurance of Medicines Terminology Database - List of Terms and relatedguideline https://www.who.int/docs/default-source/medicines/norms-andstandards/guidelines/mq...
1.2. In recent years, the number of observations made regarding the integrity of data, documentation and record management practices during inspections of good manufacturing practice (GMP), good clinical practice (GCP) and good laboratory practice (GLP) has been increasing. Possible causes for this ...
年(glossary_of_terms_june-2024.pdf()). 2世界银行的国家和贷款集团。世界银行集团,2024。 (https:///knowledgebase/articles/906519-world-bank-country-and-lending-groups). XI 全国医疗机构感染监测网 执行摘要 引言 医疗保健相关感染(HAI)是医疗保健中最 ...
They have been aligned as far as possible with the terminology in related WHO guidelines and Good Practices and included in the WHO Quality Assurance of Medicines Terminology Database - List of Terms and related guideline https://www....
Working document QAS/20.869 WHO 制药生产技术转移指南（草案）GMP办公室翻译组 WHO guidelines on the transfer of technologyin pharmaceutical manufacturing WHO制药生产技术转移指南 Background 背景 1. Introduction 介绍 2. Scope 范围 3. Glossary 术语 4. Due diligence and gap assessments 尽职调查和差距评估...
3. GLOSSARY 术语The definitions given below apply to the terms used in these guidelines. 12、 They may have different meanings in other contexts.本指南使用的术语定义如下。它们在其它环境中可能有不同的含义calibration. The set of operations that establish, under specified conditions, the relationship ...
1.2. Data governance and related measures shouldbe part of a quality system, and are important to ensure the reliability ofdata and records in good practice (GxP) activities and regulatory submissions.The data and records should be 'attributable, legible, contemporaneous,original’ and accurate, ...
(WHOguidelinesonthetransferoftechnologyinpharmaceutical manufacturing),提供了药品技术转让期间应考虑的指导原则。 本指南主体部分分为12个章节,内容如下: 背景 1.简介 2.范围 3.术语 4.尽职调查和差距评估 5.组织与管理 6.质量管理和质量风险管理 7.文件 ...
Art Terms Glossary: 1. Composition: The arrangement and organization of visual elements in a work of art. It refers to how different elements such as lines, shapes, colors, and textures are positioned to create a harmonious or dynamic composition. 2. Perspective: The technique of creating an ...
2011 WHO第961号技术报告附件7药物生产技术转移指南 Annex7附件7 WHOguidelinesontransferoftechnologyinpharmaceuticalmanufacturing WHO药物生产技术转移指南 1.Introduction介绍 2.Scope范围 3.Glossary术语 4.Organizationandmanagement组织和管理 5.Production:transfer(processing,packagingandcleaning)生产:转移(工艺、包装和...