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

Valerie Rowlands Global Industry Advisor
valerie.rowlands@envirotainer.com

A New Product Introduction, NPI, is a complex and risky process. Even though approval dates are often not known in advance, 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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At a New Product Introduction, products should preferably be delivered on the same day to every retailer in a given country or market. To ensure success, pharmaceutical companies plan their product launches months ahead, but there will always be unforeseen events that could put the product launch at stake – bad weather conditions, technical problems, strikes, thefts, packages that are stored in the wrong place, customs delays or other issues that could lead to canceled deliveries or degraded products.

As there are no inventories in the market that could be moved to meet local demand, 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. 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, it is necessary to assess the risk profile of the product and then consider the logistics costs.

  • What is the temperature range of the pharmaceutical?
  • Is the product sensitive to high or low temperatures?
  • Can it be stored for a long time in a chilled warehouse or temperature-controlled container or vehicle?
  • 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

Once product requirements have been established the next step is to plan for transport. What types of transport means are required to deliver the new pharmaceutical to its destination, without risking the product being damaged or degraded? Ocean freight is less expensive for intercontinental bulk transport but for critical shipments, such as NPI's, air transport is generally the preferred transport mode due to speed and efficiency.

3. Determine the appropriate packaging solution

The primary reason for degraded pharmaceuticals is temperature excursions. 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, 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.

There are two types of packaging for cold chain transport, passive and active packaging. 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. The heating and/or cooling technique is based on compressors or dry ice. 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. This is a part of building operational excellence that is sometimes overlooked.

4. Secure freight capacity at the product launch

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. For shipments that are critical, or for very large shipments, such agreements may be necessary.

5. Evaluate capacity and responsiveness of external partners

Apart from securing freight capacity it is also important that service providers in the logistics chain – 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. An important part of operational excellence is in other words to evaluate the services of the external partners of the logistics chain.

If sales of the new product are expected to grow significantly in the coming years, 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. Evaluate training of personnel

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, for example tarmac ground handlers, have thorough training and follow procedures and regulations. A broken cold chain is not necessarily due to technical problems but could be the result of human mistakes. 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.

A broken cold chain is not necessarily due to technical problems but could be the result of human mistakes.

7. Collaborate with proactive logistics and service providers

Logistics is not a core business of pharmaceutical companies. To succeed with the NPI process, 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, or give advice on how to keep cargo temperatures at the right level.

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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