GMP stands for Good Manufacturing Practice, which is a comprehensive term that includes regulations enforced by the FDA (U.S. Food and Drug Administration). The term sometimes appears as CGMP or cGMP, which stands for Current Good Manufacturing Practice. Other countries have adopted GMP standards under the direction of the World Health Organization (WHO). Under the authority of the Federal Food, Drug, and Cosmetic Act, the U.S. FDA holds certain manufacturing standards that must be met in the production and packaging of:
- Certain foods and supplements
- Vaccines and blood products
- Medical devices
- Animal and veterinary products
The intent of GMP is to hold U.S. manufacturers to a high, consistent standard of practice to ensure product safety and efficacy, as protection for consumers.
Why Do GMP Compliance Standards Exist?
Without such standards, companies could potentially cut corners, compromising safety by sending contaminated or mislabeled products into the marketplace. Likewise, ineffective products could find their way into stores and online vendors, leading consumers to be scammed or to receive an ineffective product for the medications and treatments prescribed by their physician. Besides consumer protection, GMP regulations are also designed to minimize errors and mixups. Manufacturers who do not comply with GMP laws can have their products recalled, seized, or otherwise removed from the marketplace, or be levied fines and prison sentences.
What Does GMP Include?
Here are some of the areas GMP regulates in the manufacturing and packaging industry:
- Training of personnel
- Record keeping
- Testing and verification of equipment function and environmental conditions
- Management of complaints
- Raw material acquisition
- Cleaning and sanitation processes and standards
- Validation of the manufacturing process
- Consistency from batch to batch
- Quality control throughout the process (not just the finished product)
- A clear and effective process for the recall of any batch of product
How Does It Work?
The FDA conducts rigorous inspections of manufacturers to ensure CGMP compliance, especially if the FDA has received reports of “potentially defective drug products” from consumers or industry personnel.
How Does GMP Affect the CBD Industry?
CBD has been termed the “wild west” of the cannabis industry, thanks to its sudden federal legalization without adequate time for the FDA to determine how to standardize the substance. Should it be treated as a food or a supplement? What is the maximum dosing that is safe to take? Is it safe for children and teens? The FDA is exploring all of these questions and realizes there is a need for consistent standards in the growth, manufacturing, packaging, and marketing of CBD (Cannabidiol).
As GMP is implemented in the CBD industry, consumers can buy with confidence knowing they are purchasing a safe, pure, effective product, and reputable manufacturers will benefit as the rigorous standards of GMP will weed out (forgive the pun) fly-by-night companies and startups.
GMP and NuLeaf Naturals
NuLeaf Naturals recently underwent its audit for GMP compliance and passed with flying colors. Here is a link to the inspection report. Click here to learn more about NuLeaf Naturals and our top-quality CBD products.