浅谈GLP QA工作的几点体会

来源 :2015年(第五届)药物毒理学年会 | 被引量 : 0次 | 上传用户：amincrazy

【摘要】

：

QA[Quality Assurance(质量保证)],IS09000： 2005中的定义是"质量管理的一部分,致力于提供质量要求会得到满足的信任"。在GLP体系中,无论OECD,FDA,还是CFDA,QA工作都强调对法规或规范的遵从性,QA声明所提供的是一种质量信任。接触GLP工作五年以来,笔者就工作中的几点体会进行阐述,抛砖引玉,以期与同行进行更多交流,不断进步。

【作者】

：

王凤华魏金锋

【机构】

：

北京协和建昊医药技术开发有限责任公司&中国医学科学院北京协和医学院新药安全评价研究中心,北京100176

【出处】

：

2015年(第五届)药物毒理学年会

【发表日期】

：

2015年5期

【关键词】

：

GLP QA 质量保证

下载到本地 , 更方便阅读

下载此文赞助VIP

声明 : 本文档内容版权归属内容提供方 , 如果您对本文有版权争议 , 可与客服联系进行内容授权或下架

论文部分内容阅读

其他文献

An Arrayed-Range-Gate Data Acquisition for Spatial Distribution Analysis of Myocardial Tissue Vibrat

Background,Motivation and Objective Coronary Doppler vibrometry(CDV) is a non-invasive diagnosis to detect vibrations from stenosis in coronary artery using ultrasound.

会议

Ultrasound Microbubble Capture Using Bioorthogonal Coupling:An In Vivo Validation

Background,Motivation and Objective Targeted contrast enhance ultrasound allows for the opportunity to visualize and track changes in molecular signalling pathways in relation to disease progression a

会议

How Calcifications Affect Shear Wave Speed Estimations? An Experimental Study

Background,Motivation and Objective OBJECTIVE:To quantify the effect generated by calcifications on shear wave elastography estimates.

会议

Contrast-Enhanced Ultrasound Imaging with High CTR and Improved Resolution by Bubble-Echo based Deco

Background,Motivation and Objective In microvascular perfusion imaging by contrast-enhanced ultrasound(CEUS),inhibiting the strong tissue backscatters to enhance contrast-to-tissue ratio(CTR) and impr

会议

Flow Phantom for Contrast Enhanced Ultrasound Research, Device Validation, and Clinical Training

Background,Motivation and Objective Phantoms are an important part of ultrasound research,instrument development,and clinical training.There are,however,no standardized research or commercial phantoms

会议

Embedded System for In-line Ultrasound Velocity Profile Detection

Background,Motivation and Objective The in-line assessment of the rheological properties of fluids in chemical,cosmetic,pharmaceutical,and food industries is fundamental for process optimization and p

会议

Ultrasound flow mapping for the investigation of crystal growth

Background,Motivation and Objective The production of high quality solar cells requires a deep understanding of the solidification process.Especially when time-dependent magnetic fields are used to im

会议

Cost-effective linear arrays for medical imaging fabricated using PZT thick film technology

Background,Motivation and Objective Screen-and pad-printed single element ultrasonic transducers have been successfully commercialized over the recent years.Typically,PZT(Lead Zirconate Titanate) thic

会议

基于“性味理论”探讨雷公藤配伍减生殖毒性的方法

雷公藤系卫矛科雷公藤属木质藤本植物,味辛、苦,性寒,具有祛风除湿等功效,是我国传统中药中治疗自身免疫性疾病的热点药物和首选药物.其毒副作用较大,近年来已引起临床、药学、毒理学等学科的高度重视.

会议

浅谈高校GLP实验室建设

GLP(Good Laboratory Practice of Drug)即药品非临床研究质量管理规范,意为"良好实验室规范"或"标准实验室规范",是应用于药品的非临床安全性评价研究的实验室,旨在严格控制化学品安全性评价试验的各个环节,确保试验结果的准确性、真实性和可靠性,提高登记、许可评审的科学性、正确性和公正性,更好地保护人类健康和环境安全.

会议

浅谈GLP QA工作的几点体会

与本文相关的学术论文