一、2023年全球GMP微生物监测新规核心要点 1. 欧盟GMP Annex 1(2023)颠覆性升级 动态监测常态化: 新规明确要求所有A/B级洁净区必须实施连续动态监测系统(每小时数据记录),取代传统的静态取样模式。 关键条款: "对于高风险区域,应建立基于粒子计数器的在线监测系统,数据完整性需符合GDP原则" 微生物限度新标准: 浮游...
附件为：PIC/SGMPANNEX 1 MANUFACTURE OF STERILE MEDICINAL PRODUCTS 无菌医用产品制造 2023-8-25生效 ...
而对于同一个问题,中国CFDI官网上面的回答是很机械的-采用最新的ISO标准;这样认识显然是肤浅的。不过,笔者可以预测,这个问答要修订了,因为EU GMP附录1在2023年8月25日要实施;这个EMA官网问答已经显得过时了。 2. What type of accuracy checks (annex 11 p 6) are expected for the use of spreadsheets H+V ...
30May2023ECGUIDETOGOODMANUFACTURINGPRACTICEREVISIONTOANNEX1 Title:ManufactureofSterileMedicinalProducts 35.Watertreatmentplantsanddistributionsystemsshouldbedesigned,constructedandmaintainedsoastoensureareliablesourceofwaterofanappropriatequality.Theyshouldnotbeoperatedbeyondtheirdesignedcapacity.Waterforinjectionsshouldbeproduce...
一、2023年全球GMP微生物监测新规核心要点 1.欧盟GMP Annex 1(2023)颠覆性升级 动态监测常态化: 新规明确要求所有A/B级洁净区必须实施连续动态监测系统(每小时数据记录),取代传统的静态取样模式。 关键条款 "对于高风险区域,应建立基于粒子计数器的在线监测系统,数据完整性需符合GDP原则" ...
Article1 Subject matter This Regulation lays down the rules on good manufacturing practice(GMP)for the groups of materials and articles intended to come into contact with food(hereafter referred to as materials and articles)listed in Annex I to Regulation(EC)No 1935/2004and combinations of those ...
2023GMP统》解读 附录《计算机化系2023GMP2023526〔CFDA〕正式公布了2023GMP的附录2023121日关注。一、本附录出台的背景1、与国际化接轨的要求。国内外GMP法规明显。CFDA2023GMP法规内容与国际上其他法规机构的cGMPFDA21CFRPart21121CFRPart11GMP21CFRPart11Annex11的内容是类似的,都是针构之间相互认可的前提条件之一。
There is much interest regarding additions to this latest revision of Annex 1, which has much more detail compared to previous versions. In this article, we have reviewed the section on Aseptic Process Simulation (APS), which previously consisted of five brief paragraphs, and now consists of ...
(1)comethereof,intoOctobercontact2004withon1Whereas:(1) GroupsRegulationof materials and articles listed inthosearticlesmaterials(EC)andNo 1935/2004Annex I toarticles orand combinations ofmanufacturedused inrules on goodinthosemanufacturingcompliancematerialsrecycled materials andwithand articles should be...
2023 年 8 月 25 日:发布之日起一年后生效(除8.123节外) 25 August 2024 : two years from the date of publication in Eudralex Volume 4 for point 8.123 2024 年 8 月 25 日:发布之日起两年后第 8.123 节生效 解读: 关于隔离器的背景环境:对于开放式隔离器,要求背景环境至少达到C级,不再允许D级...