--- title: Profil的GMP资格认证药房 description: Profil拥有一间GMP资格认证的药房，并具有制造试验用药品的完整制造许可。 --- [![profil-logo-wortbild-with claim-4c-offset_1000px-1](https://www.profil.com/hs-fs/hubfs/profil-logo-wortbild-with%20claim-4c-offset_1000px-1.png?width=1000&name=profil-logo-wortbild-with%20claim-4c-offset_1000px-1.png "profil-logo-wortbild-with claim-4c-offset_1000px-1")](https://www.profil.com?hsLang=zh) [![Contact](https://no-cache.hubspot.com/cta/default/481167/1f89c7d1-107f-4c8d-aa7b-f85d0dce14da.png)](https://cta-redirect.hubspot.com/cta/redirect/481167/1f89c7d1-107f-4c8d-aa7b-f85d0dce14da) [Patient information](https://www.profil.de) # [![Header_1077x260px_FurtherServices-1](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/Header/Header_1077x260px_FurtherServices-1.jpg?width=1077&height=260&name=Header_1077x260px_FurtherServices-1.jpg) GMP认证药房 Profil的GMP认证药房](https://www.profil.com/zh/services/pharmacy#) ## 药品生产质量管理规范（GMP）认证的药房 Profil拥有制造包括无菌剂型在内的试验用药品（IMP）的完整GMP制造许可。 ### 事实与数据 制造能力 - B级洁净室内A级层流（LAF） - 2个独立的C级洁净室 - 有（相关）资质的人员 - 对临床建筑内房间压差、温度和湿度的持续监测（包括24小时报警功能） - 定期进行颗粒物和微生物监测 - 定期进行工艺验证（介质灌装）   储存能力 - 大型存储设施能够在室温、2-8°C以及-20°C的条件下进行储存并配有连续温度监控系统（包括24小时报警功能） - 在卫生监管部门（杜塞尔多夫行政区政府）定期监督下的GMP设施   药剂服务 - 肠胃外给药剂型的无菌制备s - 制造含有稳定同位素（例如D2-葡萄糖）的静脉注射液 - )生产口服液体剂型（溶液剂，混悬剂） - 散装口服剂型的装填、包装和标签 - 提供比较药物 - 试验用药在研究中心（中央药房）的受控分发 - 进口非欧盟国家的医药产品作为临床试验中的试验用药（包括比较品） - 与合作伙伴合作开发试验用药的配方 ![pikto2.png](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/piktos/Icon_NewWebinar.png?width=62&height=70&name=Icon_NewWebinar.png) ### 网络研讨会 您的研究正处于临床前试验阶段吗？请观看我们的网络研讨会，了解从临床前试验到临床试验的转变。 [![立即观看](https://no-cache.hubspot.com/cta/default/481167/f1a64bf4-bec9-457f-a4f8-7782ec305726.png)](https://cta-redirect.hubspot.com/cta/redirect/481167/f1a64bf4-bec9-457f-a4f8-7782ec305726) ![Nadine_Hexagon](https://www.profil.com/hs-fs/hubfs/Mitarbeiter/Nadine_Hexagon.png?width=154&height=175&name=Nadine_Hexagon.png) ### 我们的专家 **Nadine Ullrich** IMP 负责人 [![与她联系](https://no-cache.hubspot.com/cta/default/481167/180a4c97-5313-4acd-bf8c-9bcbacf3a2f7.png)](https://cta-redirect.hubspot.com/cta/redirect/481167/180a4c97-5313-4acd-bf8c-9bcbacf3a2f7) ![Pharmacy](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/content-bilder/GMP_Certified_Pharmacy/GMP-Certified-pharmacy_Content1.png?width=220&height=220&name=GMP-Certified-pharmacy_Content1.png) ![Clean Room](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/content-bilder/GMP_Certified_Pharmacy/GMP-Certified-pharmacy_Content2.png?width=220&height=220&name=GMP-Certified-pharmacy_Content2.png) ![blank.jpg](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/piktos/Icon_References.png?width=49&height=49&name=Icon_References.png) #### References We have published with the following sponsors: ![Referenzen](https://www.profil.com/hubfs/BLUE_MOON/content-bilder/Referenzen.gif "Referenzen") [View more](https://www.profil.com/knowledge-center/references?hsLang=zh) ![blank.jpg](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/piktos/Icon_Certificates.png?width=44&height=49&name=Icon_Certificates.png) #### Certificates | ![13485_Zertifikatssiegel_black_A3](https://www.profil.com/hubfs/BLUE_MOON/piktos/ISO_134852016_certificate_blue.png) ISO 13485:2016 ![27001_Zertifikatssiegel](https://www.profil.com/hubfs/BLUE_MOON/piktos/ISO_27001_certificate_.png) ISO 27001 | ![9001:2015_Zertifikatssiegel](https://www.profil.com/hubfs/BLUE_MOON/piktos/ISO_9001-2015_certificate.png) ISO 9001:2015 ![9001:2015_Zertifikatssiegel](https://www.profil.com/hubfs/BLUE_MOON/piktos/BVMA_Logo_Certificate_size.png) BVMA Member | | --- | --- | ![blank.jpg](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/piktos/Icon_Publications.png?width=44&height=49&name=Icon_Publications.png) #### Publications Marquard J. et al., 2015. Characterization of pancreatic NMDA receptors as possible drug targets for diabetes treatment. Nature Medicine 21, 363–372 (2015). [View all](https://www.profil.com/knowledge-center/publications?hsLang=zh) Profil Germany has a GMP-certified pharmacy. The facility includes manufacturing capabilities (grade A laminar air flow, grade B and C cleanrooms, qualified personnel and comprehensive monitoring of rooms); and storage capabilities with various temperatures and appropriate health authority supervision. Profil Germany provides all the pharmaceutical services needed for running clinical trials in diabetes and other metabolic diseases. ###### Profil Institut für Stoffwechselforschung GmbH Hellersbergstraße 9 · 41460 - Neuss, Germany Telefon +49-2131-4018-345 · marketing@profil.com [Imprint](https://www.profil.com/imprint?hsLang=zh) | [Privacy Policy](https://www.profil.com/privacy?hsLang=zh)