ISPE 良好实践指南-高活化合物的遏制(密闭)ISPE Good Practice Guide - 高活密闭 Containment-2022(中文版)2 下载积分: 1000 内容提示: ISPE 良好做法指南: 高活化合物的密闭性 文档格式:PDF | 页数:123 | 浏览次数:488 | 上传日期:2023-09-21 13:02:11 | 文档星级: ...
ISPE Good Practice Guide_ Operations Management ISPE 良好实践指南-制药用水、蒸汽和工艺Sampling for Pharmaceutical Water, Steam, and Process Gases-2016(英文版) ISPE Good Practice Guide Critical Utilities GMP Compliance ispe-releases-ispe-good-practice-guide-critical-utilities-gmp-compliance-guide ISPE...
Critical Utilities GMP Compliance How to Be Compliant and Ready to Prove It 良好实践指南: 关键公用系统 GMP合规性 如何做到合规、 并可证明 Disclaimer: This Good Practice Guide is intended to provide guidance on achieving and maintaining critical utility systems compliance, and to be an aid to org...
ISPE GOOD PRACTICE GUIDE: Practical ementation of the Lifecycle Approach to Process Validation aceutical Developrhe Process Qualificatio Validatio ontinued/Ongoirq recess Verificati anufacturi Historical Statistica I Detll
https://ispe.org/publications/guidance-documents/good-practice-guide-imp-reverse-logistics)ISPE 良好实践指南:研究药品逆向物流 - 良好退货和对账实践。该指南是有关研究产品问责制、对账和销毁退货管理最佳实践的第一个集合。 It will help organizations effectively plan and implement reverse logistics policies an...
2019年3月,ISPE发布了一份新指南:Good Practice Guide: Process Validation。该指南英文全文208页。下面是ISPE官网对该指南的介绍,翻译如下,供参考和了解。 The shift in processvalidation from a one-time event to the product lifecycle approach expected bymost global markets has led to significant changes in...
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Covering a wide varietyof manufacturing types, the ISPE Good Practice Guide: Practical Implementationof the Lifecycle Approach to Process Validation is a reference of technical andscientific detail to help organizations conduct process validation fromscientifically sound development to robust reliable processes...
近日,ISPE发布了有关数据完整性的一个新的指南,名为GAMP RDI良好实践指南:数据完整性源于设计 (GAMP RDI Good Practice Guide: Data Integrity by Design)。 数据完整性,源于设计 本指南的名称——“数据完整性源于设计”,这是一个行业正在倡导的概念:从业务流程的初始计划,到支持该业务流程的计算机系统的实现、操...
近日,ISPE发布了有关数据完整性的一个新的指南,名为GAMP RDI良好实践指南:数据完整性源于设计 (GAMP RDI Good Practice Guide: Data Integrity by Design)。 数据完整性,源于设计 本指南的名称——“数据完整性源于设计”,这是一个行业正在倡导的概念:从业务流程的初始计划,到支持该业务流程的计算机系统的实现、操...