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首页> 外文会议>Rapra International Conference on Extractables Leachables for Pharmaceutical Products >APPLICATION OF QUALITY BY DESIGN (QBD) PRINCIPLES TO EXTRACTABLES/LEACHABLES ASSESSMENT: ESTABLISHING A DESIGN SPACE FOR TERMINALLY STERILIZED AQUEOUS DRUG PRODUCTS STORED IN PLASTIC PACKAGING SYSTEM
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APPLICATION OF QUALITY BY DESIGN (QBD) PRINCIPLES TO EXTRACTABLES/LEACHABLES ASSESSMENT: ESTABLISHING A DESIGN SPACE FOR TERMINALLY STERILIZED AQUEOUS DRUG PRODUCTS STORED IN PLASTIC PACKAGING SYSTEM

机译：按设计（QBD）原则在提取物/旁路评估中的应用：建立储存在塑料包装系统中的终端灭菌水性药品的设计空间

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The concept of Quality by Design (QbD) reflects the current global regulatory thinking related to pharmaceutical products. A cornerstone of the QbD paradigm is the concept of a design space, where the design space is a multi-dimensional combination of input variables and process parameters that have been demonstrated to provide the assurance of product quality. If a design space can be established for a pharmaceutical process or product, then operation within the design space confirms that the product or process output possess the required quality attributes. This concept of design space can be applied to the safety (leachables) assessment of drug products manufactured and stored in packaging systems. Critical variables in such a design space would include those variables that impact the interaction of the drug product and its packaging, including (a) composition of the drug product, (b) composition of the packaging system, (c) configuration of the packaging system and (d) the conditions of contact. This presentation proposes and justifies such a leachables design space for aqueous drug products packaged in a specific plastic packaging system. Such a design space has the following "boundaries": 1. Aqueous drug products whose pH is in the range of 2 to 8 and which contain no polarity impacting agents such as organic solubilizers and stabilizers (addressing variable a). 2. Packaging systems manufactured from materials that meet the system's existing material specifications (addressing variable b). 3. Nominal fill volumes from 50 mL to 1000 mL (addressing variable c). 4. roducts subjected to terminal sterilization and then stored at room temperatures for a period of up to 24 months (addressing variable d). The ramification of such a design space is that any drug product that falls within these boundaries is deemed to be compatible with the packaging system, from the perspective of safety, without the requirement of supporting drug product testing.
机译：通过设计（QBD）的质量概念反映了当前与药品相关的全球监管思维。 QBD范例的基石是设计空间的概念，其中设计空间是输入变量的多维组合和已经证明的进程参数，以提供产品质量的保证。如果可以为制药过程或产品建立设计空间，则在设计空间内的操作确认产品或过程输出具有所需的质量属性。这种设计空间的概念可以应用于制造和储存在包装系统中的药品的安全性（浸出物）评估。这种设计空间中的临界变量包括那些影响药物产品及其包装的相互作用的那些变量，包括（a）药品的组成，（b）包装系统的组成，（c）包装系统的配置和（d）联系的条件。本演示文稿提出并证明了在特定塑料包装系统中包装的水性药品的这种鹿设计空间。这种设计空间具有以下“边界”：1。其pH的水性药物产品在2至8的范围内，其含有无极化溶剂（如有机溶解剂）和稳定剂（寻址变量A）。 2.用材料制造的包装系统，符合系统现有材料规格（寻址变量B）。 3.标称填充体积从50毫升到1000毫升（寻址变量C）。 4.对末端灭菌进行的啮齿动物，然后在室温下储存长达24个月（寻址变量D）。这种设计空间的分支是，任何落在这些边界内的药品被认为与安全性的包装系统相容，从安全的角度来看，而不需要支持药物产品测试的要求。

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