Good Manufacturing Practices课件.ppt,Good Manufacturing Practices By: Carolina Gallango-Brun Sana Khan Vedrana Sahovic 精品文档 The Early Beginnings 1900s house-calls Home remedies, ointments and “miracle elixirs” Entertainment and music No regulations
GxPs GMP “Good Manufacturing Practice” GCP “Good Clinical Practice” GLP “Good Laboratory Practice” GTP “Good Tissue Practice” Regulatory Bodies that maintain guidelines TGA - Australia “Therapeutic Goods Administration” http://.tga.gov.au/ FDA - USA “Food and Drug Administration” http:...
系统标签: 药品 生产 manufacturing 修订 practice 质量 1 19981998 GoodManufacturingPracticeGoodManufacturingPractice (GMP)(GMP) 19981998 GoodManufacturingPracticeGoodManufacturingPractice (GMP)(GMP) 文件、自检内容介绍文件、自检内容介绍 2 •药品GMP是药品生产管理、质量管理全过程的准则;是药品质量控制的有力保证...
•GoodManufacturingPracticeisasetofregulations,codes,andguidelinesforthemanufactureofdrugsubstancesanddrugproducts,medicaldevices,invivoandinvitrodiagnosticproducts,andfoods.。。Fig.4GMPhandbooksforeveryindustry GoodManufacturingPracticesWorldwideEnforcement •GoodManufacturingPracticesareenforcedintheUnitedStatesbytheFDA...
CGMP--Current-Good-Manufacturing-Practice(中英文对照版).doc,§ 211.28 Personnel responsibilities. Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. P
2. Good manufacturing practices for pharmaceutical products (GMP) 2.1 Good manufacturing practice is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization...
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。 特殊限制: 部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。 关键 词: GoodManufacturingPractice药品生产质量管理规范 温州...
Good Clinical Practice GCPGCP GCP.ppt,By: Kris Traver and Nitin Jain Goals and Objectives To understand: The affect of Good Clinical Practices on institutions conducting Clinical Research To discuss: What is GCP Guidelines for GCP The history of Good Cli
SOPs are mandatory for the implementation of GCP and other GxPs, namely, cGMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice), within the scope of quality systems; therefore, it is well said that without SOPs there are no GxPs: no SOPs, no quality systems, and no GxPs ...
中国科学院广州生物医药与健康研究院2024年招聘1名GMP(Good Manufacturing Practice)负责人启事 中国科学院广州生物医药与健康研究院因工作需要,面向院外公开招聘GMP车间负责人1人,具体如下: 一、招聘岗位信息 岗位名称:GMP车间负责人 招聘人数:1人 岗位主要职责:...