2.省、自治区、直辖药品监督管理局负责本辖区药品生产企业GMP认证申报资料的初审及日常监督管理工作。 二、认证申请和资料审查 1.申请单位须向所在省、自治区、直辖市药品监督管理部门报送《药品GMP认证申请书》,并按《药品GMP认证管理办法》的规定同时报送有关资料。省、自治区、直辖市药品监督管理部门应在收到申...
a Action 诉讼 ARB Arbitration 仲裁 c.l. Civil law 民法 cl. Clause 条款 IP Import permit 进口许可证 rec Reclamation 索赔,要求赔偿损失 ref Referee 仲裁人,鉴定人,受委托者 Reg. Regulations 规则,条例 Reg.No. Registered number 注册号,登记的号 repr Representative 代理人,继承人 resp Respond 承担责...
In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations. Regulatory Action ...
1.国家药品监督管理避负责全国药品GMP认证工作。国家药品监督管理局药品认证管理中心(以下简称"局认证中心")承办药品GMP认证的具体工作。 2.省、自治区、直辖药品监督管理局负责本辖区药品生产企业GMP认证申报资料的初审及日常监督管理工作。 二、认证申请和资料审查 ...
1.5.7.1 Law enforcement/forensic, 1,5.7.2 State and local government, 1,5.7.3 Education and nonprofits, and 1.5.7.4 Public utilities (water, electric, waste treatment). 1.5.7公共部门实验室:1.5.7.1执法/法医、1.5.7.2州和地方政府、1.5.7.3教育和非营利组织以及1.5.7.4公用事业(水、电、废物处理...
law method 敏感性 sensitivity 敏感性流动实验 flowrate test 膜 film , membrane 磨铣 mill 摩擦 friction 摩擦付 friction couples 摩擦系数 friction coefficient 摩阻损失 friction loss 末端毛细管阻力 terminal capillary pressure 木质素磺酸盐 lignosulfonate 模拟 analog, simulate 模式(型) model 目 mesh N ...
picsgmpmed-annex1-technical英文电子资料.pdf,PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI0322 8January2010 RECOMMENDATION GMP ANNEX 1 REVISION 2008, INTERPRETATION OF MOST IMPORTANT CHANGES FOR THE MANUFACTURE OF S
for Switzerland: Federal Law on Medicinal Products and Medical Devices (Law on Therapeutic Products - LTP), SR 812.21 and Ordinance on Establishment Licenses (ELO), SR 812.212.1. PI 032-2 3 of 11 8 January 2010 4. New texts and their interpretation 4.1 Clean room / clean air device ...
EU GMP Requirements 热度: StaatlichesGewerbeaufsichtsamtHannover EUGMPRequirements Sterilemedicinalproduct Dr.MartinMelzer GMPTrainingCourse 20-21October2009 20.10.2009Dr.MartinMelzer2 StaatlichesGewerbeaufsichtsamtHannover Dr.MartinMelzer Pharmacist/GMPInspector ...
We employed a high-throughput screening approach to identify molecules that reduce the c-di-GMP content inP. aeruginosaand, thereby, inhibit biofilm formation and disperse already formed biofilm. The mode of action of the identified c-di-GMP-reducing compounds, H6-335 and H6-335-P1, depends on...