7 steps for pharma to protect a New Product Introduction from failure

A New Product Introduction, NPI, is a complex and risky process. Even though approval dates are often not known in advance, 运输必须在批准后立即进行，并且必须符合药品的具体要求. 损坏的批次或延迟可能会使整个m88官方发布面临风险，甚至可能对公司和最终的患者造成毁灭性的后果. 这里有7个步骤，质量经理可以使用作为指导，以保护新m88官方导入过程和建立卓越的运营.

At a New Product Introduction, m88官方最好能在同一天送到指定国家或市场的每个零售商那里. To ensure success, pharmaceutical companies plan their product launches months ahead, 但总会有一些不可预见的事件可能会危及m88官方的发布，比如恶劣的天气条件, technical problems, strikes, thefts, packages that are stored in the wrong place, 海关延误或其他问题可能导致取消交付或降低m88官方质量.

As there are no inventories in the market that could be moved to meet local demand, 与常规运输成熟的药品相比，后果将严重得多. 因此，对于持续推动卓越运营改进的质量管理人员来说，为不同的场景制定计划是至关重要的. The following steps could serve as a guide to protect the NPI process.

1. Assess the product risk profile

A risk management approach is a good starting point for the NPI process. In order to decide what the logistics solution should look like, 有必要评估m88官方的风险概况，然后考虑物流成本.

• What is the temperature range of the pharmaceutical?
• Is the product sensitive to high or low temperatures?
• 是否可以长期储存在冷藏仓库或温控容器或车辆中?
• Is it a risk if it is exposed to shock and vibration?

Risk management is an integral part of operational excellence. 

2. Determine the appropriate mode of transportation

一旦确定了m88官方要求，下一步就是计划运输. 将新药运送到目的地需要什么样的运输方式, without risking the product being damaged or degraded? 对于洲际散货运输来说，海运成本较低，但对于关键货物来说，海运成本较低, 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. Determine the appropriate packaging solution

The primary reason for degraded pharmaceuticals is temperature excursions. 因此，这是质量管理人员努力实现卓越运营的关键领域. 温度漂移是一个越来越大的挑战，因为许多下一代药物必须保持在一个狭窄的温度范围内, which necessitates cold chain transport. As mentioned above, many things can go wrong at the product launch, such as custom delays or canceled flights. It is necessary to choose a solution that will work in such circumstances.

The primary reason for degraded pharmaceuticals is temperature excursions.

冷链运输的包装有被动包装和主动包装两种. 被动式包装解决方案类似于冷却箱，由热材料组成，使m88官方在特定的时间内保持在所需的温度范围内. 被动式包装不能适应不同的环境温度和运输长度是有限的.

主动包装解决方案包括带有内部恒温器的温控容器. The heating and/or cooling technique is based on compressors or dry ice. 只要集装箱电池充电或填充干冰，活性容器就能无限期地保持所需的温度范围.

制药公司必须仔细评估不同类型的包装，以尽量减少温度漂移的风险. This is a part of building operational excellence that is sometimes overlooked.

4. Secure freight capacity at the product launch

新m88官方推出的一个主要挑战是，监管机构的批准日期往往事先不知道. Hence, 制药公司需要与物流供应商合作，以确保运输空间. 一些公司选择通过签署块空间协议来保护他们的新m88官方导入过程，以确保足够的货运能力. 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. Evaluate capacity and responsiveness of external partners

除了确保货运能力，物流链中的服务提供商也很重要 – forwarders, intermediate cold storage providers, ground handlers, airlines, suppliers of containers – have the capacity to quickly respond to and solve problems locally, such as supplying additional storage space or additional containers, or solve other types of acute problems that may arise in the NPI process. 换句话说，卓越运营的一个重要组成部分是评估物流链外部合作伙伴的服务.

If sales of the new product are expected to grow significantly in the coming years, 与有能力处理大量货物的物流和服务公司合作可能是一个不错的策略. Likewise, 如果长期战略是开拓新市场，那么与拥有大型分销网络的合作伙伴合作是明智的.

6. Evaluate training of personnel

药品运输的一个挑战是m88官方由几个中介机构处理. 特别是对温度敏感的药品的运输，至关重要的是，所有人员处理包装或容器, for example tarmac ground handlers, have thorough training and follow procedures and regulations. 冷链断裂不一定是由于技术问题，也可能是人为错误的结果. In terms of operational excellence, it is therefore not only the services of external partners that must be evaluated, as mentioned above, but also that they provide adequate and on-going training of their personnel.

冷链断裂不一定是由于技术问题，也可能是人为错误的结果.

7. Collaborate with proactive logistics and service providers

Logistics is not a core business of pharmaceutical companies. To succeed with the NPI process, 制药公司需要具有前瞻性的物流合作伙伴，并能提供专家建议. 例如，服务提供商可以提供有关负载优化的建议，以最大限度地提高集装箱内的m88官方体积, or give advice on how to keep cargo temperatures at the right level.

温控容器和其他包装解决方案的供应商应提供鉴定服务，为制药公司提供可用于验证敏感货物包装的信息. 一些服务提供商还可以协助向FDA提交新药申请，以满足新的温度要求.