Understanding Warehouse cGMP Guidelines for Pharmaceutical Products

As of 2023, more than 131 million Americans take at least one prescription medication. Among those people, the average number of prescriptions taken is four. And, while such medications can provide vital, even life-saving, benefits, they can only have their intended effects when quality and potency are preserved from production to consumption. Warehouse cGMP guidelines help protect quality and potency of these products during key parts of the pharmaceutical supply chain. We’ll take a closer look at those guidelines in this article and tell you how your third-party logistics (3PL) partner can help.

What are warehouse cGMP guidelines?

Pharmaceuticals are stringently regulated by the Food and Drug Administration (FDA). The FDA’s regulatory standards for the industry are referred to as Current Good Manufacturing Practice (CGMP) standards. These standards apply to warehouses, processes, and to the products themselves.

CGMPs related to pharmaceutical warehousing include:

1. Products must be stored to prevent contamination and be positioned to allow for inspection and cleaning of the area.

Role of warehousing 3PL: A big part of preventing contamination involves keeping the warehouse clean and preventing cross contact between different products.

Cross-contact-prevention measures include:

• Separation of materials. Products in the pharmaceutical warehouse must be kept separate from each other to prevent cross contact. This includes movement of products through unauthorized areas.
• Education of associates. Warehouse staff must be trained to recognize potential allergens at the facility, the opportunities for cross contact, and the facility’s policies and procedures.
• Designation of facility sections. Areas of the warehouse containing sensitive items must be clearly identified; unapproved equipment and unauthorized personnel must be prevented from entering.
• Sanitation efforts. Associates must wash hands with soap and water after handling any pharma product. Appropriate clothing must be worn and changed or cleaned as needed. Equipment and storage areas must be maintained and cleaned in accordance with facility and/or regulatory requirements.
• Designation of supplies. Supplies such as stretch-wrap and pallets can be designated for a specific product type and their use will be solely limited to that product type.
• Quarantine of rejected items. Rejected pharmaceutical items must be appropriately identified and quarantined to prevent their use. Similarly, incomplete or incorrect packaging for any item should result in removal of that product from the available inventory pool until it can be repackaged or discarded.

2. Each lot of products must be identified with a distinctive (and traceable) code, and the lot’s status must be identified (approved, quarantined, rejected).

Role of warehousing 3PL: Items that have common characteristics important to the manufacturer (e.g., the same expiration date) are given a lot number by the manufacturer and/or by a 3PL’s warehouse management system (WMS) as they are received by the warehouse. This lot number allows your 3PL to quickly identify batches of items in the event of a recall. It also enables the 3PL to perform inventory management protocols like FIFO (first in first out; the oldest lots of items will be distributed first) and FEFO (first expired first out; the products closest to their expiration dates will be distributed first).

3. Written procedures must describe the distribution process for each product. This includes procedures for recalls.

Role of warehousing 3PL: Common recall occurrences involve products that pose safety concerns, are damaged or are at-or-near expiration, or are otherwise designated for removal from circulation by the manufacturer. As all products are scanned upon initial entry into the warehouse, your 3PL should be able to quickly identify the item’s location and segregate the items in question using its WMS. The items are placed on hold pending further instructions.

Before you find out whether your 3PL can handle a real recall, find out if it can handle fake ones. “Mock recalls” are an important part of food and pharmaceutical warehouse management provided by your 3PL. These mock recalls are “practice runs” for real recall events. Importantly, they should be orchestrated just as carefully and extensively as the real thing.

A mock recall typically proceeds as follows.

1. The customer and 3PL coordinate details of the event, including the product being ‘recalled’ and key related information (e.g., lot numbers).
2. Items are flagged by the WMS which assigns the products a segregated hold location and prevents them from being distributed. In the event the recalled product was shipped, the WMS can determine which lots were shipped and where.
3. Warehouse personnel are notified and associates each follow specific protocols.
4. ‘Recalled’ items are taken from the main warehouse floor and placed in the segregated hold location.
5. The WMS is updated as the products enter the hold location and all warehouse staff is notified of the location, and appropriate signage is displayed.
6. The customer is updated and the 3PL provider awaits further direction (e.g., whether to hold, arrange destruction of items, etc.).

4. Written procedures must describe the appropriate storage conditions for each product.

Role of warehousing 3PL: Different pharmaceutical products can have vastly different requirements in terms of temperature, humidity, and lighting. The warehousing provider must ensure that the storage of each product is in line with its specific requirements as defined by the manufacturer. This can involve temperature-controlled warehousing and/or climate-controlled warehousing space – both of which require state-of-the-art control and monitoring equipment to keep the space compliant.

• Temperature-controlled storage. A warehouse that has temperature-controlled space utilizes cooling (and/or heating) units to keep the temperature within a set range. These units are strategically placed to ensure that the area stays in range. A variety of factors will affect the quantity and placement of cooling units, including the season of the year (i.e., more units may be needed during the summer), ceiling height, density of insulation, and warehouse building materials.
• Climate-controlled storage. With climate-controlled storage, the humidity of the space is regulated in addition to temperature. Commercial humidifiers/de-humidifiers are used along with other equipment to ensure that humidity stays within required ranges for products.

What to look for in a pharmaceutical warehousing 3PL

In addition to the parameters described above, the following characteristics can help you identify 3PLs that are most qualified to handle your sensitive products.

Security Measures: Security is paramount in pharmaceutical warehousing. Look for providers with robust security measures, including access control, surveillance systems, and protocols to prevent unauthorized access.

Inventory Management Systems: An efficient inventory management system is crucial for cGMP compliance as it enables 3PL providers to segregate products and prevent cross contact.

Quality Assurance Protocols: Inquire about the warehousing provider's quality assurance protocols. This includes regular inspections, audits, and adherence to cGMP standards in day-to-day operations. 3PL providers that truly go above and beyond in this area may have specialized certifications like ISO-9001.

Trust Kanban Logistics to adhere to cGMP guidelines

With nearly 2 million square feet of warehousing space in Eastern North Carolina, Kanban Logistics is a cGMP-certified logistics provider that specializes in the warehousing and distribution of pharmaceutical products. We undergo regular cGMP audits from AIB International to ensure that our processes and procedures are in line with the most up-to-date regulations. And, as an ISO-9001-certified company, we go the extra mile to protect the safety and quality of all products in our care. To learn more about working with a 3PL provider that puts product safety and quality above all else, contact Kanban today.