If you’re looking for a pharmaceutical distribution center to store and distribute your products, the right partner can make all the difference. Quality third-party logistics (3PL) providers can protect the safety and efficacy of your products throughout crucial points of your supply chain. In this article, we help you identify the traits that set the best 3PLs apart from the rest.
Pharmaceutical CGMP regulations
Any warehousing assessment should first start with the 3PL’s ability to comply with industry regulations. Pharmaceuticals are regulated according to Current Good Manufacturing Practice (CGMP) standards from the Food and Drug Administration (FDA).
Warehousing CGMPs include:
- Drugs must be stored to prevent contamination and be positioned to allow for inspection and cleaning of the area.
- Each lot of drug products must be identified with a distinctive (and traceable) code, and the lot’s status must be identified (approved, quarantined, rejected).
- Written procedures must describe the distribution process for each drug. This includes procedures for recalls.
- Written procedures must describe the appropriate storage conditions for each drug.
Pharmaceutical products in a warehouse must also be stored under “appropriate storage conditions” as specified by manufacturers. These conditions may include requirements related to temperature, humidity and lighting within the warehouse.
5 things to look for in pharmaceutical distribution center provider
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 lean on their warehouse management systems (WMS) to segregate products within the pharmaceutical distribution center. A cornerstone of the modern warehouse, a WMS is software that manages many key warehouse functions including inventory management (including lot numbers and expiration dates), inventory positioning, order management, order visibility and customized reporting. The WMS can appoint 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 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 in which the warehouse’s temperature is managed so that it stays 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 your 3PL provider? Just about every 3PL that stores pharmaceutical products will welcome regular audits by the products’ owners – 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.
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.
Can your 3PL provider handle mock recalls? Recalls can occur when a specific lot or batch of products needs to be removed from inventory. As all products are scanned into a 3PL’s WMS upon entry into the warehouse, and every movement within the warehouse is carefully managed by the same WMS, such a recall should be relatively straightforward.
To make sure recall events run smoothly and efficiently, however, 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. In 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 your 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 centers. 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.
Lean on Kanban for pharmaceutical warehousing
If you’re looking for a pharmaceutical distribution center on the East Coast, look no further than Kanban Logistics. Located in Eastern North Carolina – with more than 1,000,000 sq. ft. of warehousing space across our campuses – Kanban’s climate-controlled facilities are ready to support your pharmaceutical supply chain. To learn more about our services, contact us today.