For each industry, there are specific warehouse logistics requirements that must be taken into account for successful processing. In the pharmaceutical industry in particular, a large number of criteria must be observed due to strict regulations. The storage of medical products is often associated with strict legal requirements. Warehousing1 has listed here for you the most important facts that need to be considered on the topics of warehouse logistics & fulfillment in the pharmaceutical industry.
Medical progress, demographic change, healthcare innovations and increasing health awareness: The pharmaceutical industry not only plays an important role in the national healthcare system, but now also functions - especially in Germany - as a decisive economic driver.
The industry is characterized by strict laws and regulations. In addition to general regulations in the area of production and operation, logistics is not spared. Requirements in the area of storage and transport of pharmaceutical products are complex and require good industry-specific knowledge.
For pharmaceutical companies, it is essential to work with specialized logistics service providers who already have experience with the storage of pharmaceutical products and thus ensure safe handling in an industry that is highly regulated by the legislator. Certifications and conditions in the warehouse are of utmost importance in the pharmaceutical industry.
The regulations for warehouses in the pharmaceutical industry are based on the GDP (Good Distribution Practice) guidelines, which came into force in 2013 and are aimed not only at all those involved in the supply chain, but also at the manufacturers themselves. These are a series of EU guidelines which, on the one hand, guarantee the safe transport and storage of products and, on the other, are intended to counteract the trade in counterfeit medicines.
Many pharmaceutical products contain thermally sensitive substances and therefore require temperature-controlled storage to guarantee their effectiveness. The same applies to humidity, which must be constantly controlled. There are certain devices in the warehouse for this purpose - on the one hand for monitoring, and on the other hand also for signaling in the event of a deviation.
In addition to the constant control of the cold chain, GDP also stipulates other regulations. At the security level, for example, it must be guaranteed that access controls of the personnel make it possible to trace back exactly who was in the warehouse at what time. In addition, precautions must be taken to ensure that no unauthorized persons have access to the warehouse. Serial number tracking must also be meticulously maintained.
Pharmaceutical logistics companies can have their compliance with GDP standards certified by external certification companies, such as DQS. The ISO 9001 standard, which guarantees uniform process quality, can also be relevant. Furthermore, there is the TAPA FSR, an internationally valid standard for the storage of assets. During corresponding audits, the storage area is inspected and the security level is classified as Level A-C.
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