If you run an organization that sells food, cosmetics, supplements, drugs, or other medical products, CGMP standards and regulations matter. Especially in cases where you use outsourced providers to store and distribute your products, you will need to ensure these standards are met all across your supply chain. But what does CGMP stand for? Why do organizations need to meet these standards? If you need warehousing and fulfillment solutions in Miami, Florida, how can you be sure they are properly certified for CGMP? Here’s what you need to know about CGMP warehousing and the answers to questions like these. The following information will help you choose the right third-party logistics partner to provide you with safe solutions for your consumers.
The Meaning and Importance of CGMP in Warehousing
cGMP stands for Current Good Manufacturing Practices. It is overseen by the Food and Drug Administration (FDA) in the United States and is a set of rules that are enforced to guarantee that producer of medical products, food, drugs, supplements, and cosmetics are taking proper designing, monitoring, and controlling measures to deliver products safely to consumers. These measures must be applied to their facilities through the production and distribution process and are the very minimum standard that the FDA believes companies should meet.
The main difference between CGMP and GMP (Good Manufacturing Practices) is that the CGMP requires that the processes and procedures are current, with up-to-date systems and technologies. It takes into consideration updates and requires companies to use the most current operations to prevent errors and contamination. Here are nine principles of CGMP that will help your organization thrive:
- Write step-by-step procedures and work instructions to give your employees a road map for CGMP compliance.
- Carefully encourage management and warehouse staff to follow written procedures and instructions to prevent contamination, mix-up, and errors.
- Promptly and accurately document your data and procedures using virtual real-time software to increase visibility.
- Prove your systems work as they should be validating your work.
- Integrate productivity, product quality, and employee safety into the design and construction of your facilities and equipment.
- Regularly maintain and inspect your facility and equipment for safety.
- Protect your products against contamination by making cleanliness and hygiene a part of your employee’s daily routine, especially when handling products.
- Build quality into your product by systematically controlling your components and product-related processes (ex. manufacturing, packaging, labeling, testing, distribution, and marketing.)
- Conduct planned and periodic audits and inspections for compliance and performance across your supply chain.
Why Are CGMPs Important?
It is a very serious situation when a consumer becomes mildly or life-threateningly ill from a product. Companies can deal with negative feedback through online comments that could be damaging to their business, or worse, get sued or shut down for unsafe practices and procedures. A consumer alone cannot detect if a drug or supplement is safe just by using their senses, not to mention they have no way of knowing if it will even work. This is why the following efforts must be made:
- Products must be tested according to CGMP standards to ensure quality (batch testing)
- Drugs must be manufactured under CGMP practices and standards at every step
- Facilities must be in good condition
- Equipment must be properly calibrated and maintained
- Employees must be trained and qualified
- Processes must be reliable
Meeting CGMP Standards for Outsourced Warehouses
Qualifying for CGMP is not a difficult task for logistics companies. All they need to do is document all processes and procedures governed by the regulations, implement these standards, monitor them regularly to ensure they are met and subject themselves to passing all of the inspections by licensing authorities. Some warehouses take it to the next level and choose to be more proactive by paying a properly licensed organization to perform site visits to make their facility certified. If passing scores are received, the warehouse will receive a certification.
How Does a Warehousing Provider Qualify for CGMP?
Here are some of the aspects that, if met by CGMP standards, qualify warehouses as safe.
- Warehouse Construction: Are the roads and parking lots around the warehouse safe during the rainy and snowy seasons? Are stocks in the truck secured to prevent shaking and damage? Are measures being taken to prevent pests by removing garbage and keeping the area outside clear of nests? Are there regular inspections of the property to prevent roof leaks and damage to the building?
- Warehouse Safety: Are procedures in place to prevent and stop the spread of fires (sprinklers, fire extinguishers, etc.)? Are there First Aid boxes around the warehouse? Are there First Aid-trained staff in case of emergencies?
- Pest Control: Are you eliminating any evidence and presence of pests and pest waste (prevent birds, rats, cockroaches, ants, and other pests from entering the warehouse and getting near the products)?
- Training: Are warehouse teams properly trained and certified to do their jobs efficiently and timely? How often do your employees have opportunities to be trained and refreshed on their skills? Do they have training in safety measures?
- Transportation: Are trucks regularly inspected to prevent leaks, damaged flooring, nails and screws protruding, etc.? Are they kept clean and sanitary to transport edible products?
Why Choose APS Fulfillment, Inc.?
Choosing a 3PL provider that does its due diligence to ensure health and safety when handling and manufacturing food, drugs, medical products, and supplements is your best chance at having a safe and successful supply chain. If you’re ready to grow your business or provide accurate and affordable fulfillment services to your customers that meet CGMP standards, we can help you.
APS Fulfillment Inc. is ready to provide e-commerce fulfillment, product fulfillment, and direct mail marketing services so you can get the most out of your operations. You can contact us by e-mail at [email protected] or by phone at (954) 582-7450.