制药公司保护新全球十大赌钱软件app引入免于失败的7个步骤

瓦莱丽•罗兰兹 全球行业顾问
valerie.rowlands@basilinfracon.com

全球十大赌钱软件app导入(NPI)是一个复杂而有风险的过程. 尽管批准日期通常事先不知道, transport must take place immediately after approval and must follow the specific requirements of the pharmaceutical. Damaged batches or delays could put the whole product launch at risk and could even have devastating consequences for the company and ultimately the patients. Here are seven steps that quality managers could use as a guide to protect the NPI process and to build operational excellence.

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在新全球十大赌钱软件app介绍会上, products should preferably be delivered on the same day to every retailer in a given country or market. 确保成功, 制药公司会提前几个月计划全球十大赌钱软件app上市, but there will always be unforeseen events that could put the product launch at stake – bad weather conditions, 技术问题, strikes, thefts, 包被存放在错误的地方, 海关延误或其他问题可能导致取消交付或降低全球十大赌钱软件app质量.

由于市场上没有库存可以转移以满足当地需求, consequences will be much worse compared to regular shipments of well-established pharmaceuticals. It is thus crucial for quality managers who continuously drive operational excellence improvements to plan for different scenarios. 以下步骤可以作为保护新全球十大赌钱软件app导入过程的指南.

1. 评估全球十大赌钱软件app风险概况

风险管理方法是新全球十大赌钱软件app导入过程的良好起点. 以决定物流解决方案应该是什么样子, it is necessary to assess the risk profile of the product and then consider the logistics costs.

  • 药品的温度范围是多少?
  • 全球十大赌钱软件app对高温敏感还是低温敏感?
  • Can it be stored for a long time in a chilled warehouse or temperature-controlled container or vehicle?
  • 如果暴露在冲击和振动中会有危险吗?

风险管理是卓越运营的一个组成部分. 

2. 确定合适的运输方式

一旦确定了全球十大赌钱软件app要求,下一步就是计划运输. What types of transport means are required to deliver the new pharmaceutical to its destination, 不会有全球十大赌钱软件app损坏或退化的风险? Ocean freight is less expensive for intercontinental bulk transport but for critical shipments, such as NPI's, 由于速度快、效率高,航空运输通常是首选的运输方式.

3. 确定合适的包装方案

药物降解的主要原因是温度漂移. This is consequently a key area for quality managers in their efforts to achieve operational excellence. Temperature excursions are an increasing challenge as many next generation pharmaceuticals must be kept at a narrow temperature range, 哪些需要冷链运输. 如上所述, 在全球十大赌钱软件app发布会上,很多事情都可能出错, 比如海关延误或航班取消. 有必要选择在这种情况下有效的解决方案.

药物降解的主要原因是温度漂移.

冷链运输的包装有被动包装和主动包装两种. Passive packaging solutions are similar to cooling boxes and consist of thermal materials that keep the products at the required temperature range for a specific number of hours. Passive packaging cannot adjust for varying ambient temperatures and shipment length is limited.

Active packaging solutions consist of temperature-controlled containers with internal thermostats. 加热和/或冷却技术是基于压缩机或干冰. Active containers keep the required temperature range indefinitely as long as the container batteries are recharged or the containers are refilled with dry ice.

Pharmaceutical companies must carefully evaluate different types of packaging in order to minimize the risks of temperature excursions. 这是构建卓越运营的一部分,有时会被忽视.

4. 确保全球十大赌钱软件app发布时的货运能力

A major challenge at a New Product Introduction is the fact that approval dates from regulatory bodies are often not known in advance. Hence, pharmaceutical companies need to partner with logistics providers that can secure shipment space. Some companies choose to protect their NPI process by signing block space agreements to secure enough freight capacity. 对于至关重要的货物,或者非常大的货物,这样的协议可能是必要的.

5. 评估外部合作伙伴的能力和响应能力

Apart from securing freight capacity it is also important that service providers in the logistics chain – forwarders, 中间冷库供应商, 地面处理程序, airlines, 货柜供应商- 是否有能力在当地快速反应并解决问题, 例如提供额外的存储空间或额外的容器, 或解决新全球十大赌钱软件app导入过程中可能出现的其他类型的紧急问题. An important part of operational excellence is in other words to evaluate the services of the external partners of the logistics chain.

全球十大赌钱软件app的销量预计在未来几年将大幅增长, it may be a good strategy to partner with logistics and service companies that have the capacity to handle larger volumes. Likewise, if the long-term strategy is to expand to new markets it is advisable to have partners with large distribution networks.

6. 评估人员培训

A challenge with transport of pharmaceuticals is that products are handled by several intermediaries. Especially for transport of temperature-sensitive pharmaceuticals it is crucial that all the personnel handling packages or containers, 比如停机坪地勤人员, 是否接受过全面的培训并遵守程序和规章制度. A broken cold chain is not necessarily due to 技术问题 but could be the result of human mistakes. 在卓越运营方面, 因此,必须评价的不仅是外部伙伴的服务, 如上所述, 而且,它们还应为其人员提供充分和持续的培训.

A broken cold chain is not necessarily due to 技术问题 but could be the result of human mistakes.

7. 与物流和服务供应商合作

物流不是制药公司的核心业务. 要使新全球十大赌钱软件app导入过程取得成功, pharmaceutical companies need logistic partners that have a proactive approach and that can give expert advice. Service providers can for example give advice on load optimization to maximize product volume inside containers, 或者就如何将货物温度保持在合适的水平给出建议.

Providers of temperature-controlled containers and other packaging solutions should have qualification services that provide pharmaceutical companies with information that can be used to verify the packaging for sensitive shipments. Some service providers can also assist in filing new drug applications for FDA submission to meet the new temperature requirements.

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