What Challenges Can Be Expected In Pharmaceutical Warehousing Industry?
Pharmaceutical warehouse management presents some distinct issues. Even though they do not exist in businesses like general retail, many of these difficulties can have a significant impact on drugs.
Warehouse managers face a number of challenges, including:
- Keeping parts of their facilities at the proper temperature to avoid drug spoilage.
- Following government imposed excellent manufacturing process guidelines.
- Product and intellectual property security concerns.
- Inventory management.
The following are MHRA approved warehousing UK challenges unique to the pharmaceutical industry:
- Temperature control is typically required for active pharmaceutical ingredients (APIs), precursor compounds, and finished pharmaceuticals. A cool, dry area 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. For example, according to Baystate Health, hormone-containing drugs do not work as well in colder or hotter conditions.
- Moisture condensation inside packages can reduce the effectiveness of medications. 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 includes keeping track of where items are in the warehouse.
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 climate-controlled rooms with temperature and humidity controls.
Pharmaceutical Warehouse Management Challenges
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 degradation of the finished 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 sorts of goods that appear on the packaging bill of materials, all of which must follow GMP guidelines. Unique lot numbers are required for each of these item types:
- 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. Pharmaceutical companies are likewise subjected to intensive government inspection.
Other GMPs in the pharmaceutical business require suppliers to examine products depending on their intended application. Checking beginning chemicals, for example, to ensure that they are:
- According to a company-approved source
- Damage-free and defect-free
- All required information is labeled
- Have a distinctive identifier
- In the inventory database of the company.
- Quarantined pending the results of quality control testing.
For flammable and poisonous materials, they should be stored 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, all materials that fail these tests should have their own area.
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 like dust, microbes, pollen, cleaning agents, and lubricants from entering) and negative air pressure (i.e., the air pressure is lower than outside, allowing contaminants like dust, microbes, pollen, cleaning (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. When the airlock is closed, negative air pressure can be used to keep chemicals from contaminating the bigger warehouse.
Other federally mandated sampling room standards include clean instruments and proper personal protective equipment (PPE).
OSHA and the Food and Drug Administration (FDA). A warehouse safety booklet 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 of the items is correct (e.g., current, expired, etc.)
- Unique IDs are prominently shown.
- When possible, products are organized by type.
Toxins and addictive medications or chemicals are kept in different locations. Only authorized personnel have access.
Materials are tracked as they pass through the manufacturing facility.
From the Receiving area to Production and finally to Shipping
Warehouse managers should keep damaged or returned goods, recalled items, “not for sale” samples, and counterfeit materials in separate sections 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.
Pharmaceutical labeling has additional requirements:
- Dates of expiration
- Additional tracking options with barcodes
- Indicators of status, usually in the form of a color code
- Products under quarantine
- 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 also 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 the federal code of regulations, 21 CFR Chapter 1. For more details, see this article from Cornell Law School.
Taking on Challenges
Warehouse management computer systems, 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
- Mobile device usage
- Support for batch and serial items
- Routing and printing of labels
Managing pharmaceutical warehouses entails dealing with challenges that are not seen in other industries. One of them complies with FDA warehousing rules known as GMPs. Chief financial officers and warehouse managers can avoid and overcome these challenges and more by using excellent warehouse management software.