内容PROCEDURE 3 5.1 GENERAL INFORMATION ON THE MANUFACTURE 3 5.2 QUALITY MANAGEMENT 4 5.3 PERSONNEL9 5.4 PREMISES AND EQUIPMENT 10 5.5 DOCUMENTATION 13 5.6 PRODUCTION 14 5.7 QUALITY CONTROL 18 5.8 DISTRIBUTION, COMPLAINTS, PRODUCT DEFECTS AND RECALLS 18 5.9 SELF-INSPECTIONS20 6 附件ATTACHMENTS21 7 ...
EU GMP Annex 1 : Manufacture of Sterile Products DRAFT Annex 1 : Manufacture of Sterile Products 附录 1 :无菌药品生产 Document map 文件导览 Section Number General overview 章节编号 概览 1. Scope Includes additional areas (other than sterile products) where the general principles of the annex can...
that a cleanroom (or clean area) meets a defined class of the ISO 146441 standard 认证:认证洁净室 (或洁净区)符合一个ISO 146441标准所定义的等级 • Performed every 6 to 12 months (as required in ISO 146442) 每六个月到1年需做一次 (ISO 146442要求) • To a specific procedure…特定...
DIFFERENCES不同点 US GMPs only consider the possibility of recalling a product, and that recall should be performed according a procedure. Writing procedures should be established to notify the firm responsible official about the recall. FDA basis its recall strategy in the approval of the recall ...
In order to provide for the same level of access to critical medicines to all the patients in the Union, the centralized procedure is mandatory for orphan products, biotechnological products, advanced-therapy products (gene therapy, somatic cell therapy and tissue engineering) and products intended ...
In section 8.47, the disinfection procedure for transfer of items into Grade A and B areas is outlined together with the necessity of demonstrating that the disinfection process is effective in reducing any contamination on packaging to acceptable levels. This will increase the focus on ...
In the middle of the spectrum, many laboratories opt for data models that are procedure-centric (that is, test methods are defined from approved external procedures and SOPs) in which the requestor selects the appropriate tests based on knowledge of which procedures are appropriate for the sample...
•Toaspecificprocedure…特定流程 •Numberofsamplepoints(√offloorarea,inm 2 )定义采样点的数量(面积开平方) •Locationofsamplepoints(equidistantandworkheight)定义采样点位置(距离高度等) •Volumeofairsampledateachpoint每个采样点的空气采样体积
Pursuant to the attached letter from AGENT, we •药品主文件持有者的姓名地址hereby authorize AGENT to act on behalf of •与FDA的联系人和在美国的代理HOLDER with respect to all matters concerning •每个人员的简历和具体职责this the required procedure, we are •承诺声明submitting a duplicate ...
9-2 EDQM对欧盟GMP的要求和原料药厂商检查-2 英文 q p EU GMP requirements and inspections of API manufacturers organized by EDQM 2012 June 2012 Shanghai Shanghai, , 29 29 June