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Industry Best Practices for Pharmaceutical-Grade Storage

In light of the COVID-19 pandemic, the Food and Drug Administration (FDA) has placed an even greater emphasis on safe and sustainable storage of pharmaceutical goods and products. Both federal law and international organizations have established numerous rules and regulations for the intake, storage, transportation, and distribution of pharmaceutical products, and failing to abide by them could lead to a loss of business as well as serious civil or criminal consequences.

If your business handles pharmaceutical products of any kind, you should ensure you are aware of industry best practices for pharmaceutical-grade storage. Here are a few particularly critical factors to keep in mind as you work to build a safe storage environment for these sensitive and essential products.

Quality and Risk Management Systems

Among the various best practice guidelines outlined by the U.S. Pharmacopeia for the distribution of FDA-regulated products, two of the most important for warehouse managers to emphasize are the implementation of systems to minimize the risk of product contamination and systems to control product quality. According to the USP, a good Risk Management System should track:

  • The types of drugs a business has in its inventory
  • How many stages each product must go through in the supply chain
  • What instructions each product’s manufacturer provides regarding proper storage
  • Which substances may become damaged if stored at the wrong temperature

Consequently, the Quality Management System (QMS) for a warehouse that handles pharmaceutical products should take all the aforementioned pieces of information into account and establish strict procedures for employees to follow so they can maintain each product’s efficacy and integrity. The QMS should be a warehouse’s single source for guidance on what protocols to adhere to, how to record the fulfillment of those protocols, and what action should be taken in the event of a deviation.

Perhaps most importantly, both these systems should be robust enough to allow for intra-warehouse protocols and best practices to evolve over time in response to new information and new products. This focus on continuous improvement rather than overreliance on a static set of rules can be key to maintaining prospects for future business growth.

Best Practices for Pharmaceutical Storage

Like risk and quality management systems, plans for the storage of pharmaceutical products should take every part of the supply chain into account, including the receipt of new products, transferal of products within or outside of a storage facility, and where products may be stored both temporarily and on a long-term basis. Specific industry best practices to follow when it comes to safely storing pharmaceutical-grade products include:

  • Maintaining drug products at the temperature indicated on their labels
  • Setting up storage facilities for easy cleaning and control of environmental conditions
  • Using storage areas big enough to prevent overcrowding
  • Separating products based on whether they are approved, rejected, returned, recalled, or quarantined

Temperature Management Concerns

While temperature monitoring systems are crucial to ensuring pharmaceutical-grade products can be stored at the right temperature, they can only work effectively if they comprehensively track the temperature throughout an entire storage unit – whether that unit is a single freezer, a shipping container, or an entire facility. With that in mind, it may be a good idea to have a professional temperature mapping service performed to identify any areas where the heat or cold may leak out of or into a secure storage space. This analysis should help identify potential thermal risks and measure the stability and uniformity of temperature on all axes.

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