Logistics Warehousing within the Pharmaceutical Supply Chain
Safety is paramount when it comes to the supply chain for pharmaceutical products. The warehouse is perhaps the most important element of the supply chain for the safety of pharmaceutical products. This article will discuss the logistics of pharmaceutical warehouses. It will also tell you what to look for in third-party logistics providers (3PL).
Information about Pharmaceutical Warehousing
Pharmaceuticals have strict regulations from the Food and Drug Administration and Drug Enforcement Administration. Current Good Manufacturing Practices (CGMPs) are the FDA’s industry standards. They are also known as “Good Manufacturing Practices” [GMP] standards. These standards are applicable to MHRA approved warehousing UK and the drug itself.
The following CGMPs are related to warehousing:
- To prevent contamination, drugs must be kept safe and positioned so that they can be inspected and cleaned.
- Every lot of drug products should be identified by a unique (and traceable code) and must also be identified as to its status (approved, rejected, quarantined or in-process).
- The distribution process must be described in writing. These procedures include recall procedures.
- Written procedures should describe the proper storage conditions for each drug.
Climate-controlled and temperature-controlled warehouses
This is a major problem in pharmaceutical warehousing. Different drugs have different storage requirements. Each drug must be stored in accordance with the manufacturer’s requirements. 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 within specific environmental parameters.
- Temperature-controlled storage. A warehouse that has temperature-controlled space utilizes cooling (and/or heating) units to keep the temperature within a set range. The units are strategically placed so that the temperature remains within a set range. There are many factors that will influence the placement and quantity of cooling units. These include the season (i.e. more units might be required during the summer), the height of the ceiling, the density of insulation and the materials used in warehouse construction.
- Climate-controlled storage. While many people use this term interchangeably with temperature-controlled storage, there are key differences between the two. Climate-controlled storage regulates the humidity and temperature of the area. Commercial humidifiers/de-humidifiers are used along with other equipment to ensure that humidity stays within required ranges for products.
- Temperature mapping. Temperature mapping uses sensors to measure temperatures in different parts of the warehouse. Many 3PLs will conduct temperature mapping several times per year. Based on the results, they adjust heating or cooling equipment. If mapping shows an area that is too hot, cooling equipment can be placed in the correct place.
- Temperature monitoring. Temperature monitoring. While temperature mapping can be used to ensure optimal temperature coverage, temperature monitors are responsible for the daily observation and management. Kanban 3PLs partner with external monitoring firms to monitor temperatures and notify key personnel immediately of any significant changes.
Common characteristics are important to the manufacturer. For example, items with the same expiration dates are given a lot number by them and/or a 3PL’s warehouse manager system (WMS). when they arrive at the warehouse. The lot number allows 3PLs quickly identify batches of items in case of recall. This allows the 3PLs to quickly identify batches of items in the event of a recall using inventory management protocols such as FIFO (first in, first out; oldest lots will be distributed) and FEFO (“first expired first out); products closest to their expiration dates shall be distributed first).
Cross Contact Prevention
Some pharmaceutical products can be sensitive and may not work well with other products. Exposure to other products can adversely affect the efficacy and effectiveness of certain pharmaceuticals. Cross contact, i.e. exposure to one product from another, is a major concern in pharmaceutical storage such 3PL warehouses.
Cross-contact-prevention measures include:
- Separation of materials. Separation of materials in the pharmaceutical warehouse. This includes the movement of products within unauthorized areas. Kanban’s warehouses have a section where certain products cannot be loaded, stored or transported by anyone other than authorized personnel.
- Education for associates. Warehouse workers must be able to identify potential allergens in the facility and how they can cross-contact. They also need to be familiar with the policies and procedures of the facility.
- Sections of the facility must be clearly identified. The warehouse must clearly identify areas containing sensitive items. Unauthorized equipment and personnel cannot be allowed to enter.
- Sanitation efforts. After handling any pharma product, associates must wash their hands with soapy water. Proper clothing should be worn, and must be changed or washed as necessary. It is important to maintain and clean equipment and storage areas in accordance with regulatory and facility requirements.
- Designation of supplies. You can designate supplies such as pallets and stretch-wrap for a particular product type. Their use will only be allowed for that product type.
- Quarantine for rejected items To prevent them from being used, rejected pharmaceutical items should be properly identified and quarantined. Incorrect or incomplete packaging of any item should be grounds for removal from the product pool, until it is repackaged or disposed.
Recalls and mock recalls
Recalls are common and involve products that have been damaged, near expiration, recalled due to safety concerns or removed from circulation. The 3PL will be able to identify the location of each item and separate them using its WMS, as all products are scanned at the point of entry. The items are put on hold while further instructions are made. The customer can either pick up the items and have them destroyed or the 3PL can destroy them and give documentation to the customer.
Before you determine if your 3PL is capable of handling a real recall, it’s important to find out if the 3PL can handle fake recalls. Your 3PL will provide mock recalls to help you manage your food and pharmacy warehouse . These mock recalls serve as “practice runs” for actual recall events. They should be conducted as meticulously and thoroughly as the real thing.
Typically, a mock recall proceeds as follows.
- Details of the event are coordinated by the customer and 3PL, including product recall information and other key information (e.g. lot numbers).
- The warehouse management software (WMS) flags items and assigns them a separate hold location. This prevents them being distributed. The WMS can identify which lots of the recall product were shipped and where they were shipped.
- Warehouse staff are notified, and each associate follows specific protocols.
- Recalled items are removed from the main warehouse floor and placed at the segregated holding location.
- As products enter the warehouse, the WMS is updated. All warehouse staff are notified and signage is posted.
- The 3PL provider has been updated with the customer and awaits any further instructions (e.g. whether to hold or arrange for destruction of items). Please click here.
The process of a “real” recall will be the same as a mock recall. The real thing should run smoothly after systems and staff have gone through successful practice runs.
5 things you should look out for in the pharmaceutical supply chain 3PL
The following five questions will help you start your search for a 3PL that can handle key pharmaceutical supply chains responsibilities like warehousing.
Does the 3PL have to segregate products properly? There are many specific requirements for pharmaceutical products. A product may need to be kept away from food, pharma products, or items that have strong odors, such as tires and coffee. These requirements should be met by your 3PL. It is not enough to segregate products. Your 3PL must also commit to taking extra steps to avoid cross-contact as described above.
Does the 3PL warehouse have climate control? Some pharmaceutical products require that their storage environment be within a certain temperature and/or humidity range. These requirements should be met by your 3PL. You also need to ensure that there are safeguards in case the temperature or humidity drops below these limits.
Do you want to audit your 3PL provider? Almost every 3PL that stocks pharmaceutical products welcomes regular audits from the product owners, whether they are announced or not. These audits may include an inspection of storage conditions, product placement and potential hazards, as well as records and training protocols.
Also, the FDA might periodically inspect warehouses that stock pharmaceutical products. The best 3PLs are in constant audit readiness and always ready for an FDA or other auditing agency to visit.
Does your 3PL have flex space? Many companies are rethinking their inventory management strategies in the wake of COVID-19, which caused supply chain disruptions. Some companies may need to have more product in stock at their distribution centers. You will need to ensure that your 3PL is able to handle fluctuations in inventory volumes, whether they are up or down. You can also adjust your costs to meet your service and space requirements.
Are your 3PLs ISO-certified? It is essential that you have a set of guidelines for managing the various elements of your pharmaceutical supply chain. It’s easy to be ISO9001-certified. To ensure consistency and quality, ISO-certified companies must conform to strict international standards.
There are many ISO-9001 standards that govern product recalls. These include standards to identify and control non-conforming outputs (products that have been damaged, expired or are otherwise not in compliance with requirements). Companies must demonstrate compliance with all standards in order to be ISO certified.