What Is AKA GMP Certification?

Some people believe that economies work best with as little regulation as possible. Although it’s true that regulatory scrutiny passes costs onto consumers, every thriving economy with strong prospects of long-term stability has ample regulatory controls.

In the United States, which has the world’s best and brightest economy, the U.S. Food and Drug Administration oversees all domestic business that involves food, drink, supplements, and medications.

The FDA maintains Current Good Manufacturing Practice regulations for drug and supplement manufacturers. Although supplement manufacturers are held to much less stringent regulations than their drug-making counterparts, supplement-manufacturing companies still don’t have it easy.

Here, we’ll discuss the American Kratom Association’s GMP Certification Program and what kratom vendors need to go through to gain this exclusive certification.

 

What Does the American Kratom Association Do?

In response to scrutiny from the Food and Drug Administration and the Drug Enforcement Administration that began in 2016 [LINK TO ARTICLE ABOUT FDA HISTORY], the American Kratom Association began campaigning to keep kratom legal. One of its main objectives is to increase regulation in the kratom industry. As one of the leading organizations in the world of kratom, the AKA uses its platform to reward vendors who meet the FDA’s CGMP standards.

The American Kratom Association’s Good Manufacturing Practice (GMP) Certification Program is fully independent of the FDA’s CGMP guidelines. Although kratom vendors don’t have to meet these guidelines, the best vendors strive to meet them for two reasons:

  • To uphold the good reputation of the kratom industry.
  • To boost their own reputation as legitimate kratom vendors.

The AKA recognizes vendors that meet its certification requirements on its website. Many consumers visit this page to find the most reliable vendors in the industry. Although meeting these requirements ends up increasing the costs of the products, many consumers willingly pay higher prices to help sustain the kratom industry’s good name.

To qualify for the program, companies must pay to have their operations audited by independent third parties. In exchange, companies can use the “AKA Certified” logo on their products, websites, and marketing materials.

 

Major Parts of the AKA GMP Certification Program

Currently, the AKA splits criteria for this program into four areas: Standard Operating Procedures, Recordkeeping, Adverse Event Reporting System and Recalls, and Marketing Practices.

 

Standard Operating Procedures

Under Standard Operating Procedures, the AKA has a total of nine points of interest under Personnel, Manufacturing Facility and Equipment, and Manufacturing Operations.

Vendors must have formal documentation that outlines procedures to follow to prevent microbial contamination. This must also outline general hygienic practices. In addition, vendors need to create employee compliance training programs.

Qualifying kratom processors and vendors need to regularly test their workplace surfaces through swab tests. These tests must be regularly recorded as part of their quality control operations.

Finally, vendors need to create written procedures for processing, packaging, and storing products. Other important items include randomized sampling strategies, raw material contamination tests, and criteria for disqualifying suppliers.

 

Recordkeeping

Vendors must keep records for at least two years after they distribute their products. These records need to be readily accessible should the AKA, FDA, or other regulatory agencies ask to see them.

Every different product sold needs a master manufacturing record. These records ensure vendors uphold product characteristics from batch to batch. Every batch should be documented with batch production records.

Batch production records offer detailed information about every individual batch that passes through vendors’ hands, include weights, times and dates, and testing results.

 

Adverse Event Reporting System and Recalls

Vendors should have established procedures, known as adverse event reporting systems, to follow if they discover that products are contaminated with potentially dangerous substances.

 

Marketing Practices

Labeling and advertising should never claim that kratom can cure or treat diseases. They also should claim that kratom can make users high. Lastly, labels shouldn’t link to any research or clinical data.

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