9 Dust, vapour and fume control 粉尘、蒸汽和烟雾控制 10 10 Protection of the environment 环境保护 11 11 Commissioning 试运行 11 12 Qualification 确认 11 13 Maintenance 维护 12 1Introduction介绍 略 2Scope范围 These guidelines focus primarily on GMP for the design, qualific...
This document represents Part 2 of the HVAC systems guidelines. It contains non-binding examples, drawings, technical representations and interpretation in support of Part 1 of the HVAC systems guidelines. 本文件代表第二部分的暖通空调系统指南。它包含非强制性的示例、图纸、技术描述及说明,作为第一部分...
若翻译内容有不当之处，还望不吝赐教。GOOD MANUFACTURING PRACTICES FOR HEATING, VENTILATION AND AIR-CONDITIONING SYSTEMS FOR NON-STERILE PHARMACEUTICAL DOSAGE FORMS: PART 2非无菌制剂暖通空调系统GMP：第二部分 INTERPRETATION OF PART 1 – GMP FOR HVAC SYSTEMS 第一部分说明-暖通空调系统GMP ...
This document represents Part 2 of the HVAC systems guidelines. It contains non-binding examples, drawings, technical representations and interpretation in support of Part 1 of the HVAC systems guidelines. 本文件代表第二部分的暖通空调系统指南。它包含非强制性的示例、图纸、技术描述及说明,作为第一部分...
Guidelines for testing normal and patient plasmas will be random and must reflect the thromboplastins and plasma used to control oral anticoagulant therapy with order of blood collection if this is considered random. As an example vitamin K antagonists. WHO Technical Report Series 2013; No. 979: ...
1、附件14Annex 14WHO现场主文件编写指南11WHO guidelines for drafting a site master file1. 介绍 Introduction2. 目的 Purpose3. 范围 Scope4. 现场主文件的内容 Content of site master file附件Appe ndix现场主文件的内容Content of a site master file1基于制药检查会议对药品生产商编写现场主文件的注释...
changes per hour. Manufacturers should also establish how much time it takes for a room, which is out of its classification, to return within the specified class. This is often referred to as clean-up or recovery time. A guidance time period for clean-up or recovery is about 15 to 20 ...
1、WHO 937 Annex 附件2Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms在GMP的基础上补充指导药剂生产的供暖,通风,空调系统的指导条例。1. Introduction 介绍2. Scope of document 文本范围3. Glossary 术语...
Data classification policy: These guidelines enable users to categorize data based on various factors, including sensitivity, confidentiality, and business value. The policy determines the levels of security, access, and handling procedures for diverse data assets. Data ownership policy: A data ownership...
(GMP) guidelines (1) within the context of the WHO Prequalification of Medicines Programme , clarifying , editorial modifications have been proposed. These changes were adopted for maintenance purposes. In order to ease reading the full guideline has been reproduced again as an Annex to the ...