欢迎您注册蒲公英
您需要 登录 才可以下载或查看，没有帐号？立即注册
x
有人问到，因此分享，2007版
GUIDELINE ON DECLARATION OF STORAGECONDITIONS: A: IN THE PRODUCT INFORMATIONOF MEDICINAL PRODUCTS B: FOR ACTIVE SUBSTANCES ANNEX TO NOTE FOR GUIDANCE ONSTABILITY TESTING OF NEW DRUG SUBSTANCES ANDPRODUCTS ANNEX TO NOTE FOR GUIDANCE ONSTABILITY TESTING OF EXISTING ACTIVE SUBSTANCES ANDRELATED FINISHED PRODUCTS 贮运指南：A药品产品信息中 B 原料药 新原料药和制剂稳定性测试指南注解附录 现有原料药和相关制剂稳定性测试指南注解附录
1. BACKGROUND 背景 Suitable storage conditions, consistent with thosedefined in the SPC should be included in the package leaflet and on the productlabelling, if appropriate, as stated in Directive 2001/83/EC. The storageconditions for medicinal products should be based on evaluation of thestability studies undertaken on the finished product. Details of the conditionsrecommended for these stability studies are included in the relevant CHMP/ICHGuidelines where storage conditions for real time studies were chosen as 25°C/60%RH supported by accelerated or, where applicable, intermediate conditions andbased on the mean kinetic temperature of climatic zone I/II, the relevant zonefor the EU. The mean kinetic temperature includes the annual variations, i.e.lower and higher temperatures during winter and summer seasons. Thus, storageat a continuous temperature of 25°C during real time stability studies coversthe actual temperature exposure likely to be encountered under ambientconditions throughout Europe, including real time excursions from 25°C. 与其在SPC中定义相一致的适当的存贮条件，应包括在包装说明书里以及在药品标签上。适当时，与指令2001/83/EC一致。药品的存贮条件应基于对制剂所做的稳定性试验的评估上。所建议的这些稳定性试验条件包括在相关的CHMP/ICH指南中，其中存贮条件实时研究被选择为25°C/60% RH，由加速或中间条件来支持，并且是基于气候带I/II和相关EU气候带的平均动态温度。平均动力学温度包括年度变化，即冬季和夏季较低和较高的温度。这样，在实时稳定性研究中持续存贮于25°C就会包括了实际可能遭遇的整个欧洲范围内室温下温度暴露情形，包括实时温度偏出25°C的情形。 2. OBJECTIVE 目的 The purpose of this guideline is to set out uniformstatements on storage conditions for inclusion in the labelling of medicinalproducts and to define when they apply. 本指南的目的是设定药品标签中所要包括的存贮条件的统一声明，以及界定什么时候适用它们。 3. SCOPE 范围 This guideline is intended as an Annex to thestability guidelines and relates to marketing authorisations for all productcategories. 本指南意在作为稳定性指南的附录，与所有药品类型上市许可相关。
| 
|手机版|蒲公英|ouryao|蒲公英
( 京ICP备14042168号-1 ) 增值电信业务经营许可证编号：京B2-20243455 互联网药品信息服务资格证书编号：(京)-非经营性-2024-0033
发表于 2016-7-19 12:06:36
置顶卡
变色卡
发表于 2016-7-19 12:08:44
