If you fail to generate good documentation while conducting the validation test runs, you will not be able to analyse the data when putting together the report. Inadequate or poor quality data to support the validation process will not survive the scrutiny of an auditor. 如果在进行验证测试运行时...
FDA Guidelines for vendor qualification Producers of biotherapeutics must make sure that every component in the manufacture, processing, and storage of the product is supplied by a qualified vendor. To that end, the vendor selection and qualification process requires: Specification- Indicat...
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Standards such as those in the DIN EN ISO series are not laws, so ISO standards differ quite fundamentally from legally binding regulations. Good Manufacturing Practice (GMP), on the other hand, is laid down in laws, regulations and guidelines. 诸如DIN...
《 》》 m o c o. a y r u o w. w w Reviewed by ISPE Ma Yiling, Zhang Jianye, Yang Yalan Initial Translation from NNE Pharmaplan 目录 Table of Contents 第一章 第一章 总总 则则 5 第一章第一章 总总 则则 Chapter1 General Provisions 5 第二章第二章 质量管理质量管理 6 第二章第...
增加了专门的质量体系管理的内容,此章节应结合 Chapter 1 of the GMP guidelines (Part I - Basic Requirements for Medicinal Products)一并阅读和理 解运用. ⬧ 将原先分散的各类要求汇总到统一的章节进行了详细的论述和要求.例如 - 增加了单向流可视化研究的要求; - 细化了隔离器和 RABs 的要求; - 细分了...
x. Process validation. 工艺验证 xi. Validation of sterilisation processes. 灭菌工艺验证 xii. Preventative maintenance – maintaining equipment, utilities and premises (planned and unplanned maintenance) to a standard that will ensure there is no additional risk of contamination. ...
5. Definitions 定义Archiving: 归档Archiving is the process of protecting records from the possibility...
12月4日,世界卫生组织(WHO)于发布《药品生产技术转移指南》(WHO guidelines on the transfer of technology in pharmaceutical manufacturing),提供了药品技术转让期间应考虑的指导原则。 WHO最新指南:《药品生产技术转移指南》(中英文对照) PharmLink指南组 蒲公英 今天 12月4日,世界卫生组织(WHO)于发布《药品生产技术...
1、Annex 4 附件 4Supplementary guidelines on good manufacturing practices: validation 药品生产质量管理规范补充指南:验证1 Introduction 简介2 Scope 范围 3 Glossary 术语4 Relationship between validation and qualication 验证和确认之间的联系5. Validation 5.1. Approaches to validation 验证方法5.2. Scope of ...