2.5. The principles of this guideline apply to contract givers and contract acceptors. Contract givers are ultimately responsible for the integrity of data provided to them by contract acceptors. Contract givers
2.12. Where production and/or quality controlis transferred from one site to another, the recommendations in the guidelinefor transfer of technology should be followed. 如果生产和/或质量控制要从一个场所转移至另一个场所,则应遵守技术转移指南中的建议。 2.13.This document should be read inconjunction...
3.6. This guide is not intended to define registration requirements or modify pharmacopoeial requirements or other guideline recommendations. For details on process development, it is recommended that other guidelines, such as those published...
WHO发布新《数据完整性指南》解读! QAS/19.819 GUIDELINE ON DATA INTEGRITY 数据完整性指南 (October 2019) 2019 年 10 月 1. INTRODUCTION AND BACKGROUND 前言与背景 1.1. Data governance and data integrity (DI) are important elements in ensuring the reliabi...
Annex 6 Guideline on bioanalytical method validation and study sample analysis 附件6 生物分析方法验证和临床试验样品分析指南 Annex 7 Good practices of national regulatory authorities in implementing the collaborative registration procedures for medical products ...
The Expert Committee adopted the Pro duction of water for injection by means other than distillation guideline and recommended that it should also be integrated into WHO’s existing guideline on Good manufacturing practices: water for pharmaceutical use . 2019 年初, WHO 秘书处委托起草了一份关于...
Republication of WHO good manufacturing practices for excipients used in pharmaceutical products, WHO Technical Report Series No. 1052, Annex 2, with two appendices.重新发布WHO关于药用辅料良好生产实践的规定,出自WHO技术报告系列第1052号文件附录2,附有两个附录。 Background背景 The WHO guideline Good man...
2.2 This guideline should be applied when transferring the technology of processes and procedures relating to active pharmaceutical ingredients (APIs), in-process bulk materials, finished pharmaceutical products (FPPs), process validation, cleaning procedure development and validation and analytical...
The World Health Organization (WHO) has published the guideline entitledGood ManufacturingPractices for pharmaceutical products: main principlesin the WHO Technical Report Series, No. 986, Annex 2, 2014(1). WHO于2014年TRS 986附录2发布了题为“药品GMP:主则”的指南。
2.2. The guideline covers ”GxP” for medicalproducts. The principles could also be applied to other products such as vectorcontrol products. 本指南涵盖了医药产品“GxP”。这些原则也可应用于其他产品,如病媒控制产品。 2.3. The principles of this guideline alsoapply to contract givers and contract ...