Warehouse management is a unique challenge for the pharmaceutical industry. These issues can have a significant impact on medication, even though they are not common in other industries like general retail.
The following are key issues that warehouse managers need to be aware of:
- To prevent medication spoilage, ensure that portions of the facility are kept at the right temperature.
- Follow federally-mandated good manufacturing process rules.
- Security concerns for intellectual property and products
- Inventory control.
The pharmaceutical industry has specific warehouse issues:
- Temperature control Precursor chemicals, active pharmaceutical ingredients (APIs), and manufactured drugs often require controlled temperatures. The temperature range for cool and dry places is between 59-77 degrees F (15-25 degrees C). Some products, such as vaccines, may need to be frozen. Exposure to temperatures outside of their range of effectiveness can result in chemical changes and decreases in drug effectiveness. Baystate Health, for example, states that hormone-containing medications don’t work well when they are exposed to higher or colder temperatures.
- Humidity control The effectiveness of the medication can be affected by moisture condensing in packages. Baystate Health warns that glucose strips exposed to humidity can give incorrect readings.
- Light Exposure: Some medications can be affected by ultraviolet light. Photodecomposition can reduce the medication’s effectiveness. Phototoxicity and photoallergy can also be caused by light exposure, as PubMed states in a 1997 post.
- Respecting the Food and Drug Administration’s (FDA) Current Good Manufacturing Processes (CGMP), standards for warehouses and processes, and drugs. This includes tracking the locations of items within the warehouse.
Kanban states that the FDA’s CGMP warehouse standards are:
- Preventing contamination: Storage must be open for inspection and cleaning.
- Identification Every drug must have a unique code that can be traced to identify its status. This code could be used to identify whether it is approved, rejected, or quarantined.
- Distribution Procedures Written procedures that describe the distribution of each drug, including recalls.
- Storage Procedures Written procedures are needed to describe the storage conditions of each drug.
Some pharmaceuticals only require temperature control for certain ranges. Others require controlled climate conditions that affect temperature and humidity.
Follow GMP Rules
GMP SOP says that manufacturers can follow the Good Manufacturing Process (GMP), rules which allow them to:
- Protect medicines and medicines raw materials during storage
- Prevent finished product degradation
- Avoid cross-contamination with other materials
- Avoid shipping damaged or expired products
Warehouse managers are also faced with the challenge of tracking three types of items on packaging bills of materials that follow GMP procedures. Each item type requires unique lot numbers.
- APIs, precursor chemicals, and other starting materials
- Packaging materials
- Print materials
Inventory control is a requirement for all warehouse managers. The government is also closely monitoring those in the pharmaceutical industry.
Other GMPs within the pharmaceutical industry require that materials coming from suppliers be reviewed based upon their use. Check the starting chemicals for any problems to ensure they are correct.
- Source: Company approved
- No damage or defects
- All information required
- Have a unique identifier
- Register in the inventory database of the company
- Quarantined until quality controls tests are conducted
- Properly and safely store them, such as in a temperature-controlled section or “Dangerous Goods” area for flammable or toxic materials
Managers of pharmaceutical warehouses should not forget to reserve an area for raw materials that have been approved and tested. For any material that fails these tests GMPSOP states, a similar area should be created.
Sampling and Testing
The room should have sections with positive pressure. This is to prevent contaminants like dust, pollen, cleaning agents, and lubricants from entering. External contaminants are kept out by an airlock that has positive pressure. The airlock sealing can allow inner testing to be performed with negative pressure. This will prevent chemicals from entering the larger warehouse.
Clean instruments and proper personal protective equipment (PPE), are other requirements for sampling rooms. These are also required by OSHA and FDA. OSHA offers a brochure that can be downloaded about warehouse safety.
The Warehouse’s Storage and Tracking
“Lacking control over material movement within the warehouse can and has led to defective products,” GMPSOP states.
The following are general warehouse practices (GWP).
- Received unused goods or finished products are kept in quarantine until they can be released.
- Correct status labels are applied to items (e.g. current, expired, etc.).
- Unique identifiers can be seen
- When appropriate, products are sorted by type
- Separately, toxins and addictive drugs are not accessible to the public. Only approved personnel have access to the chemicals.
- Material is tracked from the Receiving Area to Production to Shipping.
Warehouse managers should create separate areas to store damaged or returned goods, recalled products, samples that are not for sale, and, when possible, counterfeit materials.
Achieving accurate labeling is another challenge for pharmacist warehouse managers.
GMP regulations require labels to contain a standard name and a Unique Identification Number. This number must not be the same as the supplier’s lot numbers. The UIN must also be recorded in the laboratory, in the facility’s computer system, and production.
GMP SOP recommends not using the IUN number as a batch number.
Additional requirements for pharma labeling are:
- Expiration dates
- Additional tracking options can be provided by barcodes
- Status indicators are usually in the form of a color code
- Products that are Quarantined
- Items held for investigation
- Rejection labels are issued when an item does not meet the required standards.
- The next step in the supply chain can be completed with approval and/or release labels that indicate the item.
The high demand for medicines and other pharmaceutical products makes them attractive targets.
Warehouses must have safe storage for finished products.
Avcostar also states that formulary, drugs, and drug components can be stolen and are costly. The company suggests that a risk analysis audit be conducted to identify security vulnerabilities. According to Jeff Whitney, Arecont Vision Costar’s VP of Marketing, “The company can then concentrate on identifying and eliminating vulnerable posts and systems against malicious or modified data deletion, modification, or access,” he states.
Code of Federal Regulations 21 CFR Chapter 1 requires that all production stages are controlled, including system validation and audit trails. For more information, refer to Cornell Law School’s article.
Solutions to Your Challenges
The warehouse management module in Microsoft Dynamics 365’s Supply Chain Management is a warehouse management software that can be used to effectively manage warehouse inventory in pharmaceuticals.
Microsoft says the module “has many features to support warehouse facility at an optimal level at all times.”
The following are some of the functions of the warehouse module:
- Support for Workflow
- Using mobile devices
- Support for serial and full batch items
- Printing and routing labels
Management of pharmaceutical warehouses can present unique challenges that are not common in other industries. One is complying with FDA regulations about MHRA approved warehousing UK, known as GMPs. Warehouse managers and chief financial officers can avoid and solve these problems by using warehouse management software.