●post-approval commitment study:上市后的承诺研究 ●post-approval variation application:上市后补充申请 ●Quality by Design (QbD):质量源于设计 ●Imported Drug License (IDL):进口药品注册证 ●Manufacturing License (ML):生产许可证 ●Clinical Trial Per...
在医疗器械申请MDL(Medical Device Establishment License)注册过程中,GMP指的是"Good Manufacturing Practice",即良好生产规范。 GMP是一套制定和实施医疗器械制造过程中的质量管理要求和标准的规范。它涵盖了医疗器械的设计、开发、生产、质量控制和售后服务等方面,旨在确保医疗器械的质量、安全性和有效性符合相关法规和标...
PLA Product License Application产品许可申请 QA Quality Assurance质量保证 QC Quality Control质量控制 QMP Quality Management Procedure质量管理程序 SDA State Drug Administration国家药品监督管理局 SMP Standard Management Procedure标准管理程序 SOP Standard Operating Procedure标准操作程序 TQC Total Quality Control全面...
产品许可申请PLA Product License Application 质量管理程序QMP Quality Management Procedure 国家药品监督管理局SDA State Drug Administration 标准管理程序SMP Standard Managmert Procedure 标准操作程序SOP Standard Operating Procedure 全面质量管理TQC Tatal Quality Control 美国药典USA Uneted States Pharmacopeia 生产管理...
产品许可申请PLA Product License Application 质量管理程序QMP Quality Management Procedure 国家药品监督管理...
The Steps to receive the European GMP License (1) 取得欧洲GMP证书的步骤(1) Based on the strength of Yangtze Group, we have decided to apply for the GMP license for the following products. 基于扬子江药业集团的实力,我们决定申请以下产品的GMP证书 Terbinafine hydrochloride 盐酸特比奈酚 Omeprazole...
PLA Product License Application 产品许可申请 QA Quality Assurance 质量保证 QC Quality Control 质量控制 QMP Quality Management Procedure 质量管理程序 SDA State Drug Administration 国家药品监督管理局 SMP Standard Managmert Procedure 标准管理程序 SOP Standard Operating Procedure 标准操作程序 TQC Tata...
或者当出现投诉的时候复查。ThiscertificateiscalledGMPlicense.这就是GMP证书。.Now,everypharmaceuticalmanufacturerinthePeoplesRepublicofChinahasaGMPlicensefromtheChineseSFDA.Therefore,thereisnoneedtocontinuethispresentation,现在，每一家中国的制药企业都已经通过中国SFDA的检查并获得证书。因此，没有必要持续现状。
Article 25:?Qualified Person 1.?Qualification: The Qualified Person should, at a minimum, possess a college degree in pharmaceutical or relevant specialties (or with an intermediate professional technique certificate or a pharmacist’s license), with at least five years of practical experience in ...