|
翻译：julia 来自：蒲公英 GMP News 03/05/2016 New FDA Guidance on 'Safety by Design' 新的FDA“安全源于设计”指南 On April 11, 2016, the FDA released a new guidance on 'Safety Considerations for Product Design to Minimize Medication Errors'. 在2016年4月11日，FDA公布了“将用药失误降至最小的药品设计的安全考量”新指南。 The recommendations in this guidance apply broadly to the development stage of drug and biologic products. The guidance provides a set of principles for using a systems approach to minimize medication errors relating to drug product design and container closure design to enhance patient safety. The recommendations are intended to provide best practices on how to improve the drug product and container closure design. The guidance also contains examples of product designs that have resulted in postmarketing medication errors. Many medication errors can be avoided at the design stage by drawing on lessons learned from past medication errors and by conducting proactive risk assessments before marketing. 该指南中的建议广泛适用于药品和生物制品的研发阶段。指南提供了一套原则，使用一个系统方法来最小化由于药品设计和容器密闭设计引起的用药失误，以提高患者安全。建议意在提供最佳规范，指导如何提高药品和容器密闭设计。指南还包括了导致上市后用药失误的药品设计的例子。许多用药失误是可以在设计阶段通过汲取之前用药失误的教训，以及在上市前实施主要风险评估来避免的。 The guidance is the first in a series of three planned guidances to minimize or eliminate hazards contributing to medication errors at the product design stage. The second guidance focuses on minimizing risks associated with the design of drug product container labels and carton labeling, and the third focuses on minimizing risks when developing and selecting proposed proprietary names. 该指南是三个系列指南中的第一个。这系列指南是为了在药品设计阶段最小化或消除对用药失误的危害而制订的。第二份指南主要关注的是最小化与药品容器标签和纸盒标签设计相关的风险，第三份指南主要关注的是研发和选择拟定商业名时最小化风险。 Safety by Design: FDA expects manufacturers to perform proactive risk assessments when developing drug products to build safety into drug product throughout its lifecycle and to identify those safety characteristics of the product that they consider to be critical. A proactive risk assessment should start with an evaluation of why and how problems have occurred with similar products and should be conducted before finalizing the physical design features of a drug product. Additionally, the guideline provides examples of known problems and medication errors due to design of the drug product and container closure systems. 安全源于设计：FDA期望生产商在研发药品时实施主动风险评估，将安全嵌入药品生命周期，识别出他们认为关键的药品安全特性。主动的风险评估应从评估类似药品中的问题为什么以及如何发生开始，应该在最终确定药品的物理设计属性之前 实施。另外，指南还提供了由于药品和容器密闭系统设计引起的已知问题和用药失误的例子。 The selection of the container closure system, for example, should be based not only on stability and manufacturing considerations, but also on the ability of the design to protect against improper use: 容器密闭系统的选择，例如，应该不仅仅基于稳定性和生产方面的考虑，还应该基于保护不恰当使用的设计能力： Drug products should not be packaged in a container/closure system that implies or affords a route of administration other than the route intended; 药品不应该包装在暗示日常服用的容器/密闭系统中，而应该是包装在有意才会使用的容器中 Container closures should not look confusingly similar to those of other products within the same product line or a different product line; 容器密闭器看起来不应该与其它同类药品或不同类药品易混淆 Products that require further dilution prior to administration should not be packaged in containers that could afford direct administration; 服用前需要稀释的药品不应该包装在可以直接服用的容器中 Small-volume and large-volume injectable products whose labeling advises against admixing with other drugs should be packaged in a container with a single port; 标注不能与其它药品混合的小容量和大容量注射剂应该包装在单一接口容器中 Commercial containers should not provide an amount of drug that is incongruent with recommended doses; 商业化容器不应该提供与建议的剂量不一致的药品数量 The amount of residual drug in a system after use should be minimized to the lowest possible level; 在一个系统中使用后残留药品的数量应最小化至可以达到的最低水平 If container closures serve as the container labels, they should not have illegible lettering or make information such as product name and strength difficult to read; 如果容器密闭器用作容器标签，他们上面的字母不应该模糊，信息如产品名称和剂量不应该难以读取 Thoughtful use of unit-of-use container closures (e.g., blister packaging, calendar-packaging, sachets, and pouches) that can be dispensed intact to patients may help to reduce medication errors; 单剂量容器密闭器全部使用之后（例如，泡罩包装、日历包装、香袋和小袋）如果患者处理时不需打开可能会有助于减少用药失误 Requirements for special packaging to confer child resistance should be considered to minimize accidental ingestions. 要考虑防止儿童误开的特殊包装要求以减少意外服用 To avoid safety issues and costly redesigns when a product is already on the market, it is important to consider the end user(s) in their environments of use early in the development and design of a drug product. FDA recommends the use of proactive risk assessments (e.g. by using FMEA) early and throughout the development and design of a drug product. Identification of clinically relevant characteristics of the drug product during development will highlight potential areas for risk assessment. Risk assessments also are valuable for identifying potential medication errors that may result from postmarketing changes or additions to an already marketed drug product throughout its lifecycle. 为了避免药品上市之后的安全问题和高成本的重新设计，在药品的研发设计阶段早期就考虑在使用环境中的最终用户是很重要的。FDA建议在药品研发设计早期和整个阶段使用主动风险评估（例如，使用FMEA）。在研发中识别药品的临床相关特性能暴露潜在的风险评估领域。风险评估对于辨识药品生命周期中上市后变更，以及增加已在销售中的药品可能导致的潜在的用药失误也是很有价值的。 For more details please see the complete FDA guidance 'Safety Considerations for Product Design to Minimize Medication Errors'. 更多细节参见官网完整指南。 |
|
|
