1.12.These Guidelines develop the GMP requirements that should be applied in the manufacturing of ATMPs that have been granted a marketing authorisation and of ATMPs used in a clinical trial setting. These Guidelines do not apply to medicinal products other than ATMPs. In turn, the detailed guidel...
1、紧接上一条,其含义就是如果某些操作或管理没有法规进行规定以及没有与本GMP相同或等同的标准/法规参考则应当执行本GMP,要满足本GMP的要求。 2、关于细胞治疗、基因治疗有很多法规,但不是每个法规都会对相关的GMP要素,例如降低混淆、差错、污染与交叉污染、不可控变化风险所采取的措施,会因硬件条件、产品特点的不...
7 第四部分•先进治疗药物的GMP要求 Part IV - GMP requirements for Advanced Therapy ...
EU GMP Part IV 先进疗法药物的GMP要求 9. 生产 > 9.3. 公用工程 > 9.3.1 水 9.23. 应保证前沿药物(ATMPs)生产用水的的质量,并进行常规检查,证明水中没有污染物(化学的、生物的和视情况而定的细菌内毒素)。9.24. 应注意水系统的维护,以避免微生物繁殖的风险。对于工厂制造注射用水的情况,应特别注意...
参照修订版Directive81/851/EEC中文件第16和第24,详细的GMP原则和指导方针适用于 需获得市场授权的生产商的全部活动,也有其他广泛的与制药生产的相关过程如在医院的活 动,以及产品的临床试验。 AllmemberStatesandtheIndustryitselfareagreedthattheGMPrequirementsapplicabletothe ...
Part IV - GMP requirements for Advanced Therapy Medicinal Products Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products Other documents related to GMP and GDP Compilation of Union Procedures on Inspections and Exchange of Information ...
EU_GMP_Vol 4_pharma quality system EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health Systems and Products Medicinal Products - Quality, safety and efficacy Brussels,SANCO/AM/sl/ddg1.d.6(2012)860362 EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU ...
设施、设备和工艺应按照良好生产规范(GMP)指南的相关章节进行适当的设计、确认和/或验证,并在适用的情况下,进行持续确认。应考虑使用适当的技术(例如限制进入屏障系统(RABS)、隔离器、机器人系统、快速/替代方法和连续监测系统),以加强对产品的保护,使其免受潜在的外来内毒素/热原、颗粒物和微生物来源(如人员、物料...
EU-GMP指南-第1部分第2章-人员.pdf,EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE — GENERAL Public Health and Risk Assessment Medicinal Product – quality, safety and efficacy Brussels, 16 August 2013 EudraLex The Rules Governing Medicinal Products
(i i i) all necessary facilities for GMP are provided including: (iv) appropriately qualified and trained personnel; (v) adequate premises and space; (vi) suitable equipment and services; (vii) correct materials,containers and labels; (viii) approved procedures and instructions; (ix) suitable ...