Current Good Manufacturing Practices, often seen as cGMP or simply GMP, is a system of standards set in place by agencies that regulate the production of food and beverages, pharmaceutical products, cosmetics, medical devices, and dietary supplements. For a business to be recognized as compliant and their products to be safe for consumers, requirements include everything from sanitization of goods and facilities to employees’ technical knowledge and certification.
What is Required for GMP Compliance and Why Should I Care?
There’s a lot that goes into making sure the food and water we put in our bodies is safe. We rely on companies that produce our goods to make sure they’re as harmless as possible and to provide information on how to use and consume them correctly. It’s also a huge boost of confidence for us, the consumers, to know that the products we buy are free from contaminants. I don’t know about you, but I’d be pretty upset if my eyeliner gave me E. coli.
Here’s the list of standards a company must adopt to be compliant:
• Manufacturing facilities must maintain a clean and hygienic manufacturing area.
• Manufacturing facilities must maintain controlled environmental conditions in order to prevent cross-contamination from adulterants and allergens that may render the product unsafe for human consumption or use.
• Manufacturing processes must be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
• Manufacturing processes must be controlled, and any changes to the process must be evaluated. Changes that affect the quality of the product are validated as necessary.
• Instructions and procedures must be written in clear and unambiguous language using good documentation practices.
• Operators must be trained to perform and document procedures.
• Records must be made, manually or electronically, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations must be investigated and documented.
• Records of manufacture (including distribution) that enable the complete history of a batch to be traced must be retained in a comprehensible and accessible form.
• Any distribution of products must minimize any risk to their quality.
• A system must be in place for recalling any batch from sale or supply.
• Complaints about marketed products must be examined, the causes of quality defects be investigated, and appropriate measures must be taken with respect to the defective products and to prevent recurrence.
And that, my friends, is GMP compliance.
How Does Kratom Become GMP Compliant?
It’s a little tricky…not for kratom production to follow GMP requirements, but for kratom to be regulated as such. Where we are right now with kratom’s legal status means that a vendor must volunteer to be compliant, and that takes a lot of time, qualifications, and money. Unfortunately, it’s not every vendor’s priority to put the work and funds into following these rules. This might be why you see announcements from the FDA about finding adulterants like heavy metals in some kratom products sold by companies that can’t or won’t spend the money on accredited labs to test their products.
It is imperative that you know whom you’re buying your kratom from and what their manufacturing practices are. Check the labels, contact customer service, and never feel guilty in doing so. Your health is the most important thing in the world and falling victim to a scam – or even an honest mistake – can hopefully be avoided by following those steps.
How Do I Know if My Kratom is GMP Compliant?
If you ask me, the best way is to contact your vendor’s sales or customer service team. Accurate product labels provide a great deal of information, but either speaking with or emailing real people is the best way to gauge truth and build trust.
Take a look at the labeling on your kratom product: does it have a suggested use? Lot or batch number? Ingredients list? This is all important information to know if your product is compliant.
At Kraken Kratom, we take explicit care to follow every detail of GMP compliance. We care about kratom, and we care about our customers. Not only do we support advocacy groups leading the campaign for our favorite botanical, but we also dedicate a lot of our time to training and certifying our employees, studying the changes in law, and testing every single batch of product we sell.
How Does Kratom Becoming GMP Compliant Help the Industry?
When a vendor volunteers to adhere to the guidelines of compliance, we push the entire industry forward. You can trust that these companies are using clean, correctly installed equipment, and also that their staff is properly trained and qualified. And hopefully their adherence to GMP will encourage their colleagues and competitors to do the same.
If more companies adopted these practices, we would see a significant reduction in adulterants and contaminated products, relieving public worry and addressing some of the concerns of the FDA, DEA and HHS. Companies that move into self-regulation (before requirement) and go above and beyond in developing products with consumer safety in mind show these government agencies that we care and that we stand by our products, keeping them clean and consistent.
Closing
Kratom is not a “rogue industry,” and we need to take responsibility for keeping our plant legal and our industry thriving in a positive way. We do this by demonstrating our commitment to consumer safety through GMP compliance. This is made easier by advocacy organizations like the American Kratom Association (AKA) and Kratom Trade Association (KTA) introducing standards programs for companies to follow. It’s up to leaders in the industry to utilize these guides and maintain the forward momentum!