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Pharmaceutical warehousing: Layouts, regulations, and tools

If your daily tasks include handling pharmaceutical products, you’ve come to the right place. This article looks into pharmaceutical warehousing, the standards regulating the industry, and tools to ensure high quality and operational efficiency.

July 8, 2024
11 min read
Henry Kivimaa

Henry Kivimaa

Two workers checking pharmaceutical products in a warehouse

Storage facilities are a necessity for any business dealing with physical products. While some can get by with a small shelf in the back room of a shop or a big yard, others may need more specialized warehousing solutions. If the product is being consumed by humans, the warehousing requirements can get very strict. This is the case with pharmaceutical warehousing.

Today, we look at pharmaceutical warehousing to see what it is all about, what you need to keep in mind when storing pharmaceuticals, and what are some of the best practices.

What is pharmaceutical warehousing?

Pharmaceutical warehousing is storing and managing pharmaceuticals in purpose-built facilities that meet all the mandatory regulatory requirements set forth by agencies like the Food and Drug Administration (FDA) and the World Health Organization (WHO). Pharmaceutical warehousing involves handling, storing, and distributing pharmaceuticals while making sure the products adhere to the highest quality, efficacy, and safety standards.

Pharmaceutical warehousing standards and elements affecting pharmaceuticals

Photo of the FDA headquarters in Silver Spring, USA

You need to consider many elements when storing pharmaceuticals. These include temperature, humidity, access, security, cross-contamination, etc. To ensure proper pharmaceutical storage solutions, there are regulatory guidelines that must be followed. In the pharmaceutical industry, the main ones to consider are:

Good manufacturing practices

GMPs are set by the FDA and provide guidelines to ensure that products are consistently produced and controlled according to quality standards. They are designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

Good storage practices

GSPs are established by the WHO and ensure that pharmaceuticals are stored under appropriate conditions to maintain their quality, efficacy, and safety. These guidelines cover aspects such as temperature control, humidity, security, and inventory management to prevent deterioration and contamination.

Good distribution practices

Finally, GDPs are established by the WHO and EMA, among other regulatory bodies, to ensure that the quality of pharmaceuticals is maintained throughout the distribution process. GDPs cover the principles of proper distribution, storage, transportation, and handling practices, ensuring that products reach consumers in a safe and effective condition.

These are not the only guidelines, but some of the most important ones to follow for pharmaceutical warehousing. Some other to look into are good warehousing practices (GWPs) and good laboratory practices (GLPs).

Pharmaceutical warehousing layout

When planning your pharmaceutical warehouse layout, there are many different approaches you can take. However, there are some best practices you should first consider. Let’s cover some of them here,

1. Zoning

  • Temperature-controlled zones — Designate specific areas for products that require different temperature ranges, such as cold storage for vaccines and ambient storage for tablets.
  • Humidity-controlled zones — Certain pharmaceuticals need to be stored in low-humidity environments to prevent degradation. Make sure you have a specific area for that.
  • Quarantine areas — Allocate separate zones for products that are pending quality control checks or are returned and awaiting inspection.

2. Accessibility and flow

  • Efficient workflow design — Create a layout that facilitates smooth and logical flow from receiving, quality control, storage, picking, packing, and shipping.
  • Clear aisles and pathways — Ensure that there are wide, unobstructed aisles for easy movement of goods and personnel, reducing the risk of accidents and improving efficiency.

3. Storage solutions

  • Racking systems — Utilize high-density racking systems such as pallet racks, shelving, and automated storage and retrieval systems (AS/RS) to maximize space utilization.
  • FIFO/LIFO Implement first-in-first-out (FIFO) or last-in-first-out (LIFO) methods depending on the type of products and their shelf life requirements.

4. Security measures

  • Controlled access — Install secure access control systems to restrict entry to unauthorized persons.
  • Monitoring systems — Use surveillance cameras and alarm systems to monitor and protect against theft, tampering, or unauthorized access.

End-to-end traceability

To ensure regulatory compliance, you must have a complete overview of your products from production to shipping. Book a demo to see how Katana can give you full visibility of your operations.

5. Environmental control

  • HVAC systems — Make sure the warehouse is equipped with efficient heating, ventilation, and air conditioning systems to maintain optimal temperature and humidity levels.
  • Backup power supply — Install backup generators to maintain environmental controls in case of power outages.

6. Compliance and documentation

  • Labeling and signage — Clearly label all areas and shelves with relevant information to ensure proper storage and easy retrieval of products.
  • Record keeping — Maintain accurate records of inventory, environmental conditions, and movement of products to comply with regulatory requirements.

7. Safety protocols

  • Emergency exits and equipment — Ensure clearly marked emergency exits, fire extinguishers, and first aid kits are readily available.
  • Training and drills — Regularly train staff on emergency procedures and conduct drills to ensure preparedness for any situation.

8. Automation and technology

  • Warehouse management system (WMS) — Implement a robust WMS to track inventory in real-time, streamline operations, and improve accuracy.
  • Automation solutions — Consider automation solutions such as automated guided vehicles (AGVs) and robotic picking systems to enhance efficiency and reduce manual errors.

Many of these best practices apply to other industries as well and can greatly improve your operational efficiency and safety regardless of the type of products you handle.

Pharmaceutical supply chain

The pharmaceutical supply chain is quite a complex one. Besides the standard raw material providers, manufacturers, and distributors, the pharma supply chain also involves many other agencies. These include:

  1. Pharma benefit managers (PBMs) — PBMs play a role in negotiating prices, managing formularies, and processing prescription drug claims.
  2. Healthcare providers — Hospitals, clinics, and healthcare professionals prescribe and administer medications to patients.
  3. Regulatory agencies — Agencies like the FDA, EMA, and WHO ensure compliance with safety, efficacy, and quality standards throughout the supply chain.
  4. Pharmacies — Retail and specialty pharmacies dispense medications to patients and provide essential services such as counseling and adherence support.
  5. Logistics providers — Specialized logistics companies handle the transportation and storage of pharmaceuticals and ensure proper conditions are maintained.

All these elements work together in this intricate web to safely and efficinetly deliver high-quality pharmaceuticals to patients while complying with strict regulatory requirements.

Solutions to simplify pharmaceutical warehousing

While managing pharmaceutical storage is no easy feat, there are technological solutions to simplify the process. Let’s take a look at some of the tools and pharmaceutical storage solutions you should consider to make your life easier.

Warehouse management systems

WMS provides real-time visibility of inventory levels, locations, and movements. This ensures you always know where your stock is and allows you to manage it efficiently. Automatic replenishment features help maintain stock levels and reduce the risk of shortages or overstock. Additionally, batch tracking lets you track batches from receipt to shipment. Full traceability is also mandatory to comply with regulations and ensure recall readiness, should anything go wrong.

Environmental monitoring systems

Environmental monitoring is necessary to track temperature, humidity, and other conditions to ensure compliance with storage requirements. These systems provide instant alerts and notifications for deviations from set parameters, so you can take prompt corrective actions to maintain the integrity of pharmaceutical products.

RFID and barcode systems

RFID and barcode systems enhance the traceability of products through the supply chain. Knowing where your products are at all times ensures authenticity and reduces the risk of counterfeiting. These systems also streamline inventory management by making picking and packing processes more efficient and reducing manual errors.

Cold chain solutions

Advanced refrigeration units that provide precise temperature control must be installed for cold storage requirements. Insulated packaging ensures temperature stability during transportation and handling, which is a must for maintaining the quality of temperature-sensitive pharmaceuticals.

Data analytics and business intelligence tools

Tracking your data is necessary to forecast demand and inventory needs. This helps to optimize your inventory levels and reduce waste. Tracking your key performance indicators (KPIs) helps identify areas for improvement and drive operational efficiency.

Pharmaceutical warehousing management with Katana

One way to pave the way for a streamlined drug warehouse is by implementing a capable inventory management system. Katana Cloud Inventory Platform helps you handle all your stock management needs, from product tracking to barcode scanning to inventory planning. Besides its advanced inventory and production management features, Katana offers a wide range of integrations that make it easy to keep your data in sync, across all your business tools.

To see all the ways how Katana can help you manage your warehouse in the pharmaceutical manufacturing industry, request a demo today, and our experts will provide all the information you need.

Henry Kivimaa

Henry Kivimaa

Henry is an avid traveler with a passion for writing. Having lived most of his adult life abroad, he’s amassed a variety of experiences from many different fields. From ForEx trading to compliance to mobile engineering to demolition, he’s definitely not afraid to test out new things.

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