If you sell food, supplements, cosmetics, drugs or medical products, CGMP standards and regulations are very important to understand and implement. Especially if you use outsourced providers in the storage and distribution of your products, ensuring CGMP standards across your supply chain is critical. But what is CGMP? Does an outsourced warehouse need to meet CGMP standards? How does a logistics company qualify for CGMP? And if you’re using an outsourced warehousing and fulfillment company, how can you tell if they are properly certified for CGMP? Below, we explore all of these questions so you can make sure you choose a properly certified CGMP warehousing solution for your business.
What is CGMP?
First and foremost, it’s important to understand just what CGMP is exactly. CGMP stands for Current Good Manufacturing Practice. In the US, CGMP is overseen by the FDA (Food and Drug Administration) and is a set of regulations enforced to ensure that producers of drugs, medical products, food, some supplements products and cosmetics are properly designing, monitoring and controlling processes and facilities throughout the production and distribution in order to deliver products safely to consumers. The regulations include manufacturing, facilities, processing, packaging and holding products. Furthermore, the regulations are ‘minimum’ standards that the FDA believes US companies should meet.
Some companies call these regulations simply GMP, which means Good Manufacturing Practice. However, the “C” in the CGMP means that the processes and procedures are “current”, using up-to-date technologies and systems. Because technologies change over the years, CGMP standards take into account these changes and require companies to use sufficient technologies and systems to prevent contamination and errors.
The FDA in the US, and other regulatory agencies in other countries, are authorized to conduct unscheduled or scheduled inspections in order to check on a company’s processes and procedures. Furthermore, there are organizations that specialize in certifying companies in CGMP.
Not all products within the above listed segments are governed by CGMP standards. If you don’t know whether or not your specific products fit under these regulations, contact the FDA or view their online resources in order to check for sure.
Does an Outsourced Warehouse Need to Meet CGMP Standards?
Because CGMP regulations include the “holding” of products, outsourced warehousing companies that store and ship drugs, medical products, food, some supplements and cosmetics should comply with CGMP standards. If you are using or intend to use a third-party warehouse for these relevant products, CGMP standards must be met (unless it is a supplement or cosmetic product that is exempt).
With regard to warehouse standards, CGMP touches on all areas of warehousing: overall warehouse design, construction, fire safety, pest control, FIFO (First In, First Out) of products, batch control capabilities (for example, if a ‘batch’ ever needs to be recalled), training of the warehouse team, self-inspections, safety procedures in the warehouse (including fire prevention and extinguishers, sprinklers, first aid, etc.), stock counts, shrinkage of product, and even truck/forklift quality etc. Outsourced warehouses even have to consider areas outside of the warehouse, such as roads of entry/exit, the physical building (including the roof), garbage handling, and weather event procedures.
With such a wide reach within the warehousing industry, CGMP requires a good amount of planning. As such, any outsourced warehouse that is subject to CGMP should have a formal and documented set of procedures to comply with all regulations.
How Does a Logistics Company Qualify for CGMP?
Any warehousing provider can qualify for GMP certified status by simply documenting all processes and procedures governed by the regulations, implementing these standards, monitoring these standards on an ongoing basis, and subjecting themselves to and passing all scheduled or unscheduled site inspections by licensed authorities.
Some outsourced warehouses choose to be more proactive and pay a properly licensed organization to perform site visits and “certify” their facility. Whether an inspection is done by a governmental or paid for entity, the warehouse will receive a certification if passing scores are received. This serves as “proof” that the company is a licensed CGMP warehouse. In terms of properly vetting any potential outsourced warehouse, you can check with them and obtain any certifications that they received and review their internal formal documents related to their processes and procedures. As an example, WrightFulfillment is licensed by the Oregon Department of Agriculture as a fulfillment warehouse for vitamins and dietary supplements.
The stakes are high for many food, drug, medical, supplements and cosmetics products, so paying close attention to the certifications and capabilities of outsourced warehouse and supply chain providers is extremely important. Digging a little deeper in the due diligence process will ensure that you choose a company that is properly certified and capable of handling your products during all aspects of storage and distribution.