Pharmaceutical warehousing is an operation that preserves the integrity and quality of drugs that will affect millions of people’s health and well-being. It is closely related to the life savings and benefits of using or consuming pharmaceutical products. Therefore, pharmaceutical warehousing is more comprehensive than just simple storage of products. A well-designed pharmaceutical warehouse must ensure the safety, efficiency, and compliance with regulatory requirements of sensitive and temperature-controlled products. It should be well equipped with the right processes, technology, and procedures for handling each stage of the supply chain, including storage, picking, delivery, and product recalls. These are the keys to contributing to the success of the supply chain activities in the pharmaceutical industry. This article discusses several key focus areas of pharmaceutical warehouses.
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Compliance in the pharmaceutical industry covers multiple areas, including legal, financial, technological, medical innovation, cultural, educational, and demographics. Appropriate governance, risk, and compliance enable pharmaceutical companies to identify the right approach that can contribute to process efficiency, improvement of risk management, and internal controls. Pharmaceutical warehouses must be managed in a compliant manner to maintain product quality and protect against contamination. It could negatively affect the organization’s reputation as well as its ability to run a business without compliance or even endanger the health of consumers. The concept of compliance is sometimes seen as an obligatory expense of doing business. Still, it is an opportunity to build trust with stakeholders and improve competitive advantage and intelligent risk-taking.
In the pharmaceutical industry, temperature and humidity are considered critical factors and are a part of the regulatory requirements. The temperature and humidity levels can vary depending on the products and the nature of the operations. Still, they must be appropriate, with particular attention given to storage areas that will be used for long periods. A pharmaceutical warehouse must select the right temperature recording instrumentation, validate its processes, and maintain documentation of records and procedures, including responding to alarm conditions. The storage environment should be monitored with temperature recording devices, and the record should be reviewed and filed with their results tabulated and analyzed. If any temperature deviates outside the relevant recommended conditions, the suitability of the products for use may be affected. It is recommended that the manufacturer of the products be contacted to resolve the problem.
Standard Operation Procedures (SOPs)
The SOPs for the pharmaceutical industry are the cornerstone of daily operations. It is against the regulated law without a properly developed, approved, and controlled SOP while performing tasks. Various standardization and regulatory bodies such as European Union Good Manufacturing Practice (EU GMP), U.S. Food and Drug Administration (USFDA), World Health Organization (WHO), and Health Sciences Authority (HSA) require SOPs as part of their regulatory requirements. During the inspection process, these regulatory bodies will review the SOPs of the processes, in which the inspector can issue a non-conformance or warning if there is a deviation between the performed procedure and the approved SOP. SOPs are strictly tested and verified by relevant personnel for accuracy to prevent failure and variations from expected results. SOPs must be continuously updated in response to any changes in the process requirements or due to the latest trend, which helps to increase the efficiency and productivity of a process in the most beneficial, effective, and proven way in the pharmaceutical industry.
Qualified Warehouse Design and Layout
Pharmaceutical companies face a unique challenge in developing a warehouse design and layout due to the nature of their products. A quality warehouse design and layout can help to streamline the operation’s workflow. In contrast, a poorly designated warehouse can lead to the failure of an entire operations and supply chain. Moreover, it can also lead to inadequate storage locations and underutilization of the available storage. This results in a longer process due to the backtracking of the products, which slackens the warehouse operations and decreases the overall productivity and fulfillment rate. Traceability is essential for monitoring product expiry dates as pharmaceutical goods are sensitive to external contamination, such as bacteria or chemicals and temperature changes. Therefore, the warehouse design should also include designated segregation areas that identify approved, expired, recalled, and returned products.
Warehouse Hygiene and Sterility
To maintain the quality and integrity of every pharmaceutical product, pharmaceutical warehouses must adhere to a standard of Good Manufacturing Practices (GMP), which includes Good Distribution Practices (GDP) and Good Warehousing Practices (GWP). Pharmaceutical warehouses must maintain a clean and protected environment due to the critical nature of the product. Specific designs are implemented in the warehouse to prevent dirt, dust, particles, moisture, and pests. For instance, there are roller shutters to separate the clean room or controlled area from the general area. The workers must ensure the doors are always closed whenever possible. In addition, every pharmaceutical warehouse is required to implement a pest control protocol. The chemicals used in pest control programs must fulfill the Occupational Safety and Health (OSH) requirement to protect the surrounding environments and personnel.