The pharmaceutical business has its own set of issues when it comes to warehouse management. Many of these problems can have a big impact on drugs, even if they don’t exist in other industries like retail.
The following are some of the major difficulties that MHRA approved warehousing UK managers face:
• Keeping parts of their facilities at the proper temperature to avoid drug spoilage.
• Adherence to federally mandated excellent manufacturing process guidelines.
• Product and intellectual property security concerns.
• Inventory management.
The following are warehouse challenges unique to the pharmaceutical industry:
• Temperature control is typically required for active pharmaceutical ingredients (APIs), precursor compounds, and finished pharmaceuticals. A cool, dry location should be between 59- and 77-degrees Fahrenheit (15 and 25 degrees Celsius). Vaccines, for example, may need to be frozen. Temperatures outside of a drug’s therapeutic range can trigger chemical changes and diminish its potency. Medications containing hormones, for example, do not operate as well when exposed to colder or hotter temperatures, according to Baystate Health.
• Moisture condensing inside packages can have an impact on a medication’s effectiveness. Blood glucose strips exposed to dampness, according to Baystate Health, will yield erroneous readings.
• Light exposure: UV light from the sun and other sources can cause some drugs’ chemical structures to alter. Photodecomposition occurs as a result of the light exposure, lowering the medication’s efficacy. According to a 1997 PubMed article, light exposure might cause negative effects such as phototoxicity and photoallergy after dosing.
• Following the FDA’s Current Good Manufacturing Process (CGMP) guidelines for warehouses, procedures, and drugs: This entails keeping meticulous records of item whereabouts throughout the facility.
The FDA’s CGMP warehouse standards, according to Kanban, include:
• Preventing contamination requires storage that allows for inspection and cleaning.
• Each medicine must have a unique, traceable code that indicates whether the lot has been approved, quarantined, or rejected.
• Written procedures defining the distribution process for each drug, including recalls, are known as distribution procedures.
• Storage Procedures: Each medicine must have written procedures specifying the storage conditions.
Only temperature controls for particular ranges are required for some medications. Other drugs necessitate temperature and humidity control in a climate-controlled facility.
Observing GMP Guidelines
Following the Good Manufacturing Process (GMP) regulations, according to GMPSOP, allows firms to:
• During storage, keep medicines and raw materials for medicines safe.
• Prevent the degradation of the end product.
• Other materials should not be contaminated.
• Prevent the shipment of faulty or expired goods.
Warehouse managers also have to keep track of three different categories of goods that appear on the packaging bill of materials, all of which are governed by GMP regulations. Each of these item categories necessitates its own set of lot numbers:
• APIs, precursor compounds, and other raw materials are used to make APIs.
• Materials for packaging.
• Materials in print.
Inventory control is a need for all warehouse managers. Those in the pharmaceutical industry are likewise subjected to a great level of government monitoring.
Other GMPs in the pharmaceutical business necessitate an evaluation of materials arriving from suppliers based on their intended use. It’s critical, for example, to double-check starting compounds to ensure they’re:
• The information came from a company-approved source.
• Damage-free and defect-free.
• All needed information is clearly labeled.
• Have a one-of-a-kind identification.
• In the inventory database of the company.
• Quarantined pending the results of quality control testing.
• For flammable and hazardous materials, they should be stored properly and safely, such as in a temperature-controlled portion or a “Dangerous Goods” area.
Pharmaceutical warehouse managers should set aside an area for raw supplies that have been inspected and certified to fulfill all essential criteria, unlike retail goods warehouse managers. According to GMPSOP, any materials that fail these tests should be placed in a separate compartment.
Testing and Sampling
Sampling and testing should be done in a room with positive air pressure (i.e., the air pressure is higher than outside, preventing contaminants such as dust, microbes, pollen, cleaning agents, and lubricants from entering) and negative air pressure (i.e., the air pressure is lower than outside, preventing contaminants such as dust, microbes, pollen, cleaning agents, and lubricants from entering) (i.e., the pressure is lower than that outside to prevent materials from inside the room going outside). External pollutants are kept out by using a positive-pressure airlock. The inner testing can have negative air pressure since the airlock is sealed, preventing chemicals from polluting the bigger warehouse.
Clean instruments and adequate personal protective equipment (PPE) are also required by the federal Occupational Health and Safety Act (OSHA) and the Food and Drug Administration (FDA). A warehouse safety brochure is available for download from OSHA.
Inside the warehouse, storage and tracking
According to GMPSOP, “lack of control over material movement in the warehouse can and has resulted in defective products.”
The following are general warehousing practices (GWP):
• Unused commodities and completed products are held in quarantine until they are approved for release.
• The status labels on the items are right (e.g., current, expired, etc.)
• Unique IDs are prominently shown.
• When it’s acceptable, products are organized by type.
• Toxins and addictive medications or chemicals are kept in different locations. Only authorized personnel have access.
• Materials are traced from the Receiving area to Production and subsequently to Shipping as they move through the manufacturing facility.
Warehouse managers should keep damaged or returned goods, recalled items, “not for sale” samples, and counterfeit materials in separate locations whenever possible.
Accurate labeling is another difficulty for pharmaceutical warehouse managers. Labels must incorporate a standard name and Unique Identification Number that differs from the supplier’s lot number, according to GMP guidelines. In the lab, on the facility’s computer system, and in production, the UIN must be documented. The IUN should not be referred to as a batch number, according to GMPSOP.
The following are some more regulations specific to pharmaceutical labeling:
• Dates of expiration.
• Additional tracking options with barcodes.
• Indicators of status, usually in the form of a color code.
• Products that have been quarantined.
• Items that are being investigated.
• When an object fails to satisfy the required requirements, it is given a rejection label.
• Approval and/or release labels indicating that the item is ready to move forward in the supply chain.
Threats to Security
The increasing demand for medicines and other pharmaceutical products makes them attractive targets.
Raw materials and final products should be stored in safe physical storage rooms in warehouses.
Avcostar further claims that the formulary, medications, and drug components are all pricey and vulnerable to theft. It recommends conducting a risk analysis audit that includes the locations of known security breaches. “The company can then concentrate on identifying and eliminating the most vulnerable posts and systems against malicious access, data modification or deletion, improving access control to systems and data, and implementing new cybersecurity best practices,” says Arecont Vison Costar VP of Marketing Jeff Whitney.
Control of all production steps, including system validation and audit trails, is required under 21 CFR Chapter 1 of the Code of Federal Regulations. For further details, see this article from Cornell Law School.
Taking on New Challenges
Warehouse management computer solutions, such as the warehouse management module in Microsoft Dynamics 365’s Supply Chain Management, can assist pharmaceutical companies keep accurate track of inventories and overcome these issues.
According to Microsoft, the module “offers a wide range of functionality to support the warehousing facility at an ideal level at any time.” Among the functions of the warehouse module are:
• Workflow assistance
• Making use of mobile devices
• Support for batch and serial items is complete.
• Routing and printing of labels
Managing pharmaceutical warehouses entails dealing with challenges that are not seen in other industries. One of them adheres to GMPs, or Good Manufacturing Practices, established by the FDA for warehousing. Effective warehouse management software assists CFOs and warehouse managers in preventing and resolving these difficulties, as well as others.