When evaluating the 3PL provider in charge of your pharmaceutical distribution warehouse, safety is the name of the game. You want to make sure that your provider is doing all that it can to protect the integrity of your products while adhering to GMP guidelines.
In this article, we’ve listed several specific questions that you should ask your current or prospective 3PL provider to make sure that your pharmaceutical products are in good hands.
Key pharmaceutical distribution warehouse questions to ask a 3PL
Can the 3PL segregate products appropriately? Many pharmaceutical products have segregation requirements. For instance, a product’s appropriate storage conditions may dictate that it needs to be stored away from other foods, other pharma products, and even items that emit strong odors (e.g., tires or coffee). Importantly, it is not enough to simply segregate products – your 3PL must commit to taking additional steps to avoid cross contact at all times throughout the facility.
Most 3PLs will use their warehouse management systems (WMS) to segregate products within the pharmaceutical distribution warehouse. A cornerstone of the modern warehouse, WMS software manages many key warehouse functions, including inventory control (e.g., lot-level traceability and expiration date tracking), inventory positioning, order management, order visibility and reporting. The WMS can assign a given product to a warehouse position where it is segregated from incompatible products and then ensure that those types of incompatible products are never stored nearby or moved through that area.
Can the 3PL perform lot control? Items that have common characteristics important to the manufacturer (e.g., the same expiration date) are given a lot number by the manufacturer and/or by a 3PL’s WMS as they are received in the warehouse. This lot control allows 3PLs to quickly identify batches of items in the event of a recall. It also lets the 3PL manage inventory protocols like FIFO (first in first out; the oldest lots of items will be distributed first) and FEFO (first expired first out; the products closest to their expiration dates will be distributed first).
Can the 3PL provider handle mock recalls? Recalls can occur when a specific lot or batch of products needs to be removed from inventory.
To make sure actual recall events run smoothly and efficiently, many leading 3PLs leave nothing to chance. These 3PLs routinely perform practice runs called ‘mock recalls’ that are every bit as thorough as the real thing. During such a recall, specific items (as directed by the product owner) will be identified by the WMS and designated for quarantine as the 3PL awaits further instruction.
Can the 3PL warehouse meet your product’s climate needs? A pharmaceutical product’s appropriate storage conditions may require that it be kept within a specific temperature and/or humidity range at all times. Many 3PLs provide temperature-controlled storage within the desired range (e.g., between 56°F and 75°F).
Some 3PLs also offer climate-controlled warehousing in which both temperature and humidity are regulated.
Can you audit the 3PL provider? Just about every 3PL that stores pharmaceutical products will welcome regular audits by customers – announced or unannounced. Such audits can include a review of storage conditions, product placement, potential hazards, facility cleanliness, records and training protocols, and other factors.
The FDA may also periodically audit warehouses that store food and pharmaceutical products. The best 3PLs operate in a constant state of ‘audit-readiness’ and are always prepared for an impromptu visit by the FDA or any other auditing agency.
Is the 3PL ISO-certified? Some 3PLs – like Kanban Logistics – go a step further and undergo regular external audits as part of ISO-9001 (quality management) certification. These audits occur annually.
It doesn’t get much more buttoned up than being ISO-9001-certified. ISO-certified companies have conformed their procedures to rigorous international standards to ensure quality and consistency.
For example, there are a variety of exacting ISO-9001 standards related to product recalls, including standards to identify and control “nonconforming outputs” (products that are damaged, expired, or otherwise fall short of requirements). In order to become ISO certified, companies must be able to demonstrate consistent compliance to every letter of these standards.
Can the 3PL flex space? In the wake of COVID-19 and resultant supply chain disruptions, many companies have begun to rethink their inventory management strategies. For some, this may involve having more product on-hand at pharmaceutical distribution warehouses. If you anticipate fluctuations in your inventory volumes – whether up or down – you will want to make sure that your 3PL has the space and resources to accommodate this flexibility. Your costs will also flex up and down to match your space and service requirements.
Are the 3PL’s associates adequately trained? Warehouse staff must be adequately trained to recognize the potential allergens at the facility, the opportunities for cross contact, and the policies and procedures in effect at the facility.
Turn to Kanban for pharmaceutical distribution and warehousing
Located in Eastern North Carolina, Kanban Logistics is a pharmaceutical warehousing provider that goes the extra mile to protect your products. We undergo regular GMP audits from AIB International to ensure that our processes and procedures are in line with the most up-to-date regulations. And, as an ISO-9001-certified company, we go the extra mile to protect the safety and quality of all products in our care. To learn more about our supply chain capabilities – including our nearly 2 million square feet of East Coast warehousing space – contact us today.