The main concern in any logistics warehouse is to ensure that the products arrive intact and safe at their destination. The current good manufacturing practices standards (CGMPS), a collection of standards that are constantly evolving, aim to ensure the integrity and quality of products passing through warehouses. These practices are generally standardized by companies in the same industry. CGMPS, however, are subject to the Food and Drug Administration (FDA) and have full force and effect in pharmaceutical warehouses.
The FDA’s requirements for pharmaceutical warehouses cover all pharmaceuticals, including over-the-counter and biological products such as blood and plasma that are used in the production of pharmaceuticals. These requirements for pharmaceutical warehouses do not provide much information about design. They are concerned with maintaining temperature controls that ensure medicine is safe and effective. They provide procedures for preventing the contamination of pharmaceuticals by biological, chemical, and physical contaminants.
FDA Pharmaceutical Warehouse CGMPS
The FDA has a wide range of responsibilities. They are responsible for all existing pharmaceuticals as well as the development and testing new ones. The FDA has a wide range of responsibilities that make it difficult for them to create detailed regulations regarding the storage and handling of all pharmaceuticals. There are many different types of pharmaceuticals that require safe environments. The environment can be affected by temperature, humidity, or lighting. The FDA has a wide range of requirements regarding safe storage of pharmaceuticals.
These are the FDA requirements for facilities:
According to the FDA, pharmaceutical storage facilities must be large enough to allow for proper cleaning and maintenance. The FDA won’t allow tight warehouses that are too small to prevent operations from being interrupted and dirt and debris can build up. FDA requires that facilities have a designated area to quarantine pharmaceuticals whose temperature control has expired, use-by dates have expired or whose safety is in question.
It is important to have adequate lighting, ventilation and temperature control. To ensure that pharmaceuticals are safe and effective, humidity and temperature controls will be used. To ensure pharmaceuticals are properly stored, it is important to use the appropriate temperature and humidity logs, whether they be electronic, manual, or electromechanical.
The FDA has established security requirements for pharmaceutical warehouses to prevent unauthorized entry. Entry must be controlled and equipped with alarm systems. The FDA also requires that the warehouse’s outside perimeter be well lit.
The FDA’s requirements for pharmaceutical warehouses are divided into keeping pharmaceuticals safe, protecting pharmaceuticals from diversion, and providing safe work environments. The FDA does not mandate CGMPS, but rather sets criteria for warehouses to follow when creating their own CGMPS.
Compliance with FDA Pharmaceutical Warehouse Requirements
There are many types of pharmaceuticals, and many criteria in many fields. An exhaustive discussion on FDA compliance could fill many volumes. To be licensed by FDA as a pharmacy warehouse, the facility must submit a written plan detailing the following information.
Lists all pharmaceutical types that the warehouse will handle.
Explain how these pharmaceuticals will be stored in the warehouse to keep them effective.
Details about the type of environmental checks that will take place and how they will be recorded.
This document outlines the procedure for disposing of any pharmaceuticals found to be dangerous.
The FDA has the right to inspect any warehouse to verify that it follows approved and submitted procedures. The FDA may impose fines on warehouses found not in compliance. They can also revoke permission for them to trade in certain pharmaceuticals.
Compliance with FDA requirements for pharmaceutical warehouses is easy. It’s a matter of common-sense and meticulously documenting those practices. The use of technology like warehouse automation makes procedures easier to follow and documents that they have been followed. This is provided that the warehouse automation supports the appropriate equipment.
More information about pharmaceutical warehousing here.
How plastic pallets help companies meet FDA requirements
Traceability is a key requirement for FDA pharmaceutical warehouses. It should not be surprising that the Drug Supply Chain Security Act (DSCSA), mandates traceability. This act aims to prevent illicit drug use and diversion by requiring that a serialized tracking number (or label) be placed on all pharmaceutical packaging. This new mandate has the side effect that serialized numbers can be used to track where pharmaceuticals were kept and what storage procedures were followed. This is as easy as checking the serialized numbers in and out of each storage area, and then comparing the records of all the checks that were made during that time.
Plastic pallets are a great way to facilitate traceability. You can embed a serialized number to track the pharmaceutical storage conditions at the load unit level. This provides an additional level in traceability and allows for easier verification that the critical procedures used in the cold-chain management of pharmaceuticals were followed, such as temperature checks. Plastic pallets have a long life span and are durable. This makes it economical to place an identifier on each pallet and make it readable via Radio Frequency ID (RFID). This contrasts with wood pallets which are prone to frequent repairs and have a short life span.
Plastic pallets are stronger than wood pallets and can withstand the elements. Companies can maintain clean facilities that comply with CGMPS warehousing standards. Plastic pallets can also be cleaned easily as they are non-porous. Plastic pallets are a great way to comply with FDA requirements for pharmaceutical warehouses. They also help to protect the integrity of the supply chain.