Pharmaceutical firms must be aware of their distribution network’s strengths and weaknesses so operations can be optimized and well equipped for any disruptions.
Last year, academics shined a light on the responsibilities of pharmaceutical warehouses, urging operators to step up to their duty of curing supply chains disruptions and improving network design.
A South African study saw around 36% of respondents reveal that moving stock to hospitals was delayed usually because medicines were not available at the warehouse. Another 32% of the base noted lack of staff at the warehouse was the issue. Late medicine requests caused the delays only in a minority of cases.
Some hospital members in the study were concerned at the status of the stock received from the warehouse, with some being damaged or experiencing a break in the cold chain storage requirements.
Success in medicine distribution hinges on how efficient a warehouse is.
Network designs
Last month at Temperature Controlled Logistics 2018 Robin Doppleb, Head Global Logistics & Distribution Director, Vifor Pharmaceuticals presented his case study session on: Centralization of a Temperature Controlled European Hub.
When mapping out your network’s storage he said: “The most important factors are geographic location, pricing and the suitability of the facility itself. If you are using a large number of contract manufacturers it is useful to choose a more centralized approach”.
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Centralized warehousing: A network of lanes that use a single centralized warehouse rather than multiple smaller facilities spread out.
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Decentralized warehousing: Smaller warehouses are scattered around regions.
Robin's factors to consider
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Location: The warehousing location in relation to the nearest airport, seaport and main roads.
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Equipment: Does the facility equipment meet your needs and can it reliably store at the temperatures your products require?
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3rd party logistics: “If you have several different logistics service providers, you are likely to have much higher fixed costs.”
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Licenses: If you are storing products manufactured outside the EU, the facility will have to hold a lot of different licenses, especially for pharmaceutical GDP and GMP requirements.
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Regulatory Landscape: “Regulations are very country-specific, there is EU legislation and different regulations even within countries. Sometimes depending on where the warehouse is located there are very different legal policies to adhere to.
“We spend a large amount of time well in advance considering whether or not the particular facility we are choosing has the capability to fulfill all of the regulatory requirements.”
What are the temperature risks?
Good warehousing and distribution practice requires warehouse temperatures to be controlled and monitored. Warehouses should be temperature mapped to determine the temperature distribution and assess any areas of risk.
Appropriate action should be taken if temperatures exceed the storage conditions stated on product labels.
Temperature excursions are most likely during the loading and unloading process.
Robin stresses that the selection of the facility is crucial. “We have chosen a facility where the cold chain storage path is actually in a fully secluded area with a 2°c – 8°c loading dock, so we are not breaking the cold chain at all.”
He added: “When you’re unloading a truck within an ambient area, you have to make sure that this is being put away into the cold chain area in a very, very timely manner. If you have a 2°c – 8°c receiving dock where you can put a curtain around the receiving truck, it’s a lot easier and the people can do their work properly without as much time pressure.”
On the topic of traceability, Robin believes it all comes down to processes. “We have a lot of quality related processes behind data we receive, where we see excursions we can then take the stability data of the product into consideration and take measures based on the severity of the excursion that has occurred.”
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What are warehouse management systems?
Pharmaceutical and biologic firms should ensure warehouse management systems are used to optimize inventory management and ensure the consistent availability of stock. These systems reduce the risk of human error by providing real-time intelligence on storage restrictions and guidelines on temperature and humidity requirements. Algorithms can be applied to prevent the chances of incorrect shipments being issued as well as maximizing the use of the medicines’ expiry time.
Hospital warehouse professionals should monitor a schedule of orders and log the location of patient treatments being packaged and the whereabouts of completed orders.
The authors of the aforementioned study recommended pharmaceutical warehouse staff need to be trained on the gravity of stock management and tracking practices, any failures should be kept on file. Electronic stock-sheets or stock registers should be used to swiftly retrieve information, manual stock-cards are only advised for use in power emergencies.
Read more: Your guide to selecting warehouse management systems
Robin notes that Vifor Pharma has “A transport protocol established where you can note down the serial numbers of the loggers, where the shipment is from, where it’s going to and so on. Technology is also an enabler of efficiency, you can secure the shipments from daylight exposure or direct sunlight exposure in the storage process.”
Automation
Pharmaceutical companies are increasingly turning to fully automated warehouse solutions to meet the industry’s strict requirements and internal operational challenges. Warehouse automation provides real-time insight for quality control without the need for human contact with the substances that are being manufactured. This greatly reduces the risk of contamination and improves employee safety.
Automation via an automated storage and retrieval system and warehouse execution system increases the speed that products are moved in and out of the warehouse, providing increased productivity. One French company developed a robot that is able to climb warehouse racks and pick up to 400 orders per hour.
Such automated equipment enables manufacturers to develop new drugs with shorter time-to-market metrics, while complying with strict regulations.
However, fully automated warehouses can delay processes if there is an issue with the technology, entire systems may have to be shut down if there is an error, which can cause severe delays.