本反映了科技进步成果和基于风险的方法在GMP中的运用(2-14)。本文件内容 作为现行版WHO药品GMP中通用建议:“主要原则”(2)以及与生物制品生产和 控制相关的其他WHO专项文件的补充。 Thisdocumentisintendedtoserveasabasisforestablishingnational guidelinesforGMPforbiologicalproducts.Ifanationalregulatory authority(NRA)so...
Filling lot (final vaccine lot): A collection of sealed final containers of vaccine that is homogeneous with respect to the risk of contamination during the filling process. A filling lot must therefore have been filled or prepared in one working session. 3.3生产建议 生产必须符合GMP要求,生物安全...
Considering the varying level of implementation of GMP in WHO Member States, the ECBS decided that national regulatory authorities should decide at their own discretion whether the innocuity test is needed to release a vaccine or not [15]. However, the innocuity test was still listed in the cont...
Regulatory Action and News Influenza vaccines for 2010 southern hemisphere winter WHO Drug Information,2009,23,4 查看 Regulatory Action and News International biosafety guidelines for influenza vaccine production WHO Drug Information,2005,19,4 查看VIP...
2011年10月28日,华兰疫苗有限公司按程序及要求在瑞士日内瓦WHO总部提交了季节性流感疫苗的预认证申请,启动了华兰WHO流感疫苗GMP预认证工作。我们将持续地提高和改善生产和质量管理体系,在各方的支持和自身的努力下,更积极地参与到国际流感研究及防控中,为中国及世界流感的研究防控贡献出应有的力量。
WHO预认证相关技术指标
WHOt HP换苗质量安全性及 有效, 性指导原则GUIDELINES TO ASSURE THE QUALITY, SAFETY ANDEFFICACY OF RECOMBINANT HUMANPAPILLOMA VIRUS VIRUS
Fillinglot(finalvaccinelot):Acollectionofsealedfinalcontainersofvaccinethatishomogeneouswithrespecttotheriskofcontaminationduringthefillingprocess.Afillinglotmustthereforehavebeenfilledorpreparedinoneworkingsession. 3.3生产建议 生产必须符合GMP要求,生物安全上要求无菌。不同类型HPVL1VLP应分别生产,同时,还要有充分的清洁...
Filling lot (final vaccine lot): A collection of sealed final containers of vaccine that is homogeneous with respect to the risk of contamination during the filling process. A filling lot must therefore have been filled or prepared in one working session. 3.3生产建议生产必须符合GMP要求,生物安全...
- - -word.zl- 3、临床方面:〔略〕 三、生产指导〔PartA.Guidelinesonmanufacturing〕 3.1定义definitions 3.1.1国际名称和专有名称 国际名称:重组人乳头瘤类病毒颗粒疫苗〔基因型16L1蛋白〕 3.1.2定义描述 重组HPVVLP疫苗为无菌的液态疫苗,里面含纯化后由一种或多 种HPV基因型重组的主要的衣壳蛋白,并与相应佐剂...