8. There is nochange category for a change in the variation guideline, what should I do? 若变更未在变更指南中有分类,申请人应怎么办? A change that is notaddressed in the WHOguidelines on variations to a prequalified product (variation guideline) should be considered as a major change by...
The definitions given below apply to the terms used in this guidelinethat are not defined in existing WHO terms and definitions databases. They mayhave different meanings in other contexts. Note: For general definitionsrelating to chromatography, see the relevant pharmacopoeia recognized by thenational...
This guideline applies to human and veterinary medicines.This document is intended to provide guidance on the pharmaceutical use of different grades of water in the manufacture of active pharmaceutical ingredients and medicinal products.Executive summary 1. Introduction (background) ...
附件4 数据完整性指南 本文件取代《世卫组织关于良好数据和记录管理规范的指南》（附件5,世卫组织技术...
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原文地址：https://www.gmp-compliance.org/guidelines/gmp-guideline/eu-gmp-annex-11-computerised-...
Air changes per hour (ACPH) Ref. Guideline: ISO 14644 Air changes in pharmaceutical cleanrooms play a significant role in maintaining the clean room quality as per ISO Clean Room Classification through the HVAC system. Air change per hour is the number of total replacements of any room air ...
This guideline applies to human and veterinary medicines.This document is intended to provide guidance on the pharmaceutical use of different grades of water in the manufacture of active pharmaceutical ingredients and medicinal products.Executive summary 1. Introduction (background) ...