When it comes to the pharmaceutical supply chain, the word “safety” comes to mind. The warehouse, maybe more than any other part of the supply chain, is critical to the safety of pharmaceutical goods.
Pharmaceutical Warehousing is a part of the pharmaceutical supply chain.
The Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) have strict regulations in place for pharmaceuticals (DEA). Current Good Manufacturing Practice (CGMPs; sometimes known as “Good Manufacturing Practice” [GMP]) standards are the FDA’s regulatory requirements for the industry. Pharmaceutical warehouses, procedures, and pharmaceuticals themselves are all subject to these guidelines.
The following CGMPs apply to warehousing:
- To avoid contamination, drugs must be kept in a way that allows for examination and cleaning of the area.
- Each lot of drug items must be recognized by a unique (and traceable) code, as well as the lot’s state (approved, quarantined, rejected).
- Each drug’s distribution process must be described in writing. This covers recall processes.
- The proper storage conditions for each medicine must be described in writing.
Temperature and environment control in storage
These “proper storage conditions” constitute a key pharmaceutical warehousing problem. In terms of temperature, humidity, and illumination, various medications may have quite varied requirements. The warehouse provider must verify that each medicine is stored in accordance with the manufacturer’s specified specifications. This can include temperature-controlled warehousing and/or climate-controlled warehousing, both of which need cutting-edge control and monitoring systems to maintain specified environmental conditions.
Storage that is kept at a specific temperature. To keep the temperature within a given range, a warehouse with temperature-controlled area uses cooling (and/or heating) systems. These units are carefully distributed around the region to ensure that it remains within range. Season of the year (i.e., more units may be required during the summer), ceiling height, insulation density, and warehouse construction materials are all factors that influence the amount and location of cooling units.
Storage in a regulated environment. While many people confuse this word with temperature-controlled storage, there are several important distinctions between the two. In climate-controlled storage, not only the temperature but also the humidity of the room is controlled. Commercial humidifiers/dehumidifiers are used in conjunction with other equipment to keep humidity levels within product specifications.
The mapping of temperature. Sensors are used in this procedure to detect temperature in various parts of the warehouse. Most 3PLs will conduct a temperature mapping procedure multiple times a year and alter cooling and heating equipment as a result of the findings. For example, if mapping reveals that a certain region is very hot, the location of cooling equipment will be altered.
Temperature measurement. Temperature monitoring is the day-to-day observation and control of such temperatures, whereas temperature mapping is a proactive approach of guaranteeing optimal temperature coverage. Kanban, for example, works with external monitoring businesses to check temperatures in real time and promptly notify important staff of any significant changes.
As items are received by the warehouse, the manufacturer and/or a 3PL’s warehouse management system (WMS) assign them a lot number based on shared criteria significant to the manufacturer (e.g., the same expiry date). In the case of a recall, 3PLs can rapidly identify batches of merchandise using this lot number. It also allows the 3PL to use inventory management protocols such as FIFO (first in, first out; the oldest lots of things will be distributed first) and FEFO (first in, first out; the oldest lots of items will be distributed first) (first expired first out; the products closest to their expiration dates will be distributed first).