What is the AKA GMP Qualified Kratom Vendor Status?

You may, or may not, have heard of the AKA GMP Qualified Kratom Vendor Status – short for American Kratom Association Good Manufacturing Practices Qualified Kratom Vendor Status. Regardless, many kratom users and non-kratom users are in the dark when it comes to this regulated, high-standard status. 

Developed by the American Kratom Association, the AKA GMP standards program represents online kratom vendors who are willing to commit to implementing and following the standards outlined in the AKA GMP Standards Program. This monitoring program gives buyers peace-of-mind when it comes to purchasing kratom online, knowing the online vendor they’re buying from has a higher quality level in regards to their products and manufacturing process. 

In this article, we will discuss the American Kratom Association Good Manufacturing Practices processes and the compliance standards involved in the program.

 

How to earn the AKA GMP Qualified Kratom Vendor Status?

In order to become an AKA GMP Qualified Kratom Vendor, manufacturers must commit to the following strict processing and manufacturing standards outlined below – after which, the manufacturer will need to have their work reviewed through a verification process that’s performed by a pre-approved, independent auditor. 

Standard Operating Procedures

  • Personnel
    • Kratom vendor must establish and show proof of following written procedures in order to prevent contamination from potentially sick or infected staff members – including hygienic practices throughout their facility.
    • Establish and implement a personnel compliance training program including maintaining up-to-date documentation of the training process.
  • Manufacturing Facility and Equipment
    • Establish and implement procedures that ensure the kratom facility remains in a condition that protects kratom products from the possibility of contamination.
    • Maintain a clean and sanitized facility, including storage, production, processing, and packaging areas – establish a cleaning schedule and proof of it.
  • Manufacturing Operations
    • Establish and implement procedures for the process of receiving material, quarantine, production/processing, packaging areas, storage and sale/shop areas – with written proof of procedures. 
    • Establish and implement a randomized sampling schedule to ensure quality – written on paper.
    • Establish and implement written procedure for the analysis of raw materials including microorganisms of public health concern, heavy metals, chemical contaminants, synthetic drugs and shelf-life testing.
    • Establish and implement a raw material receiving procedure, ensuring all incoming raw materials undergo an initial quarantine pending on test results and confirmation that said ingredient meets set specifications.
    • Establish and implement a full written procedure for how you’ll be qualifying ingredient suppliers, including any procedures that may trigger the disqualification of any given supplier.

Record Keeping

  • Generally
    • All records should be filed/sorted and kept in storage for a minimum of 1 year past the shelf life date of the product.
    • Records should always be readily accessible and kept in a standardized manner to ensure they can be obtained and reviewed by an independent third party auditor at any time.
  • Master Manufacturing Records
    • Establish and follow/maintain a written Master Manufacturing Record for each unique formulation of kratom product that you manufacture and sell. This includes each batch size to ensure uniformity in the finished batch, from batch to batch.
    • The Master Manufacturing Records must identify specific steps within the manufacturing process – particularly where any control is necessary to ensure the quality of the kratom product and that it is labeled correctly. The name, strength, concentration, weight or measurement of each ingredient used within the kratom product for each batch size. 
  • Batch Production Records
    • Establish and maintain the production records of each batch, each and every time you manufacture a batch of said kratom product(s), for each of your offered kratom products.
    • Batch Production Records must include the complete information relating to production and control of each batch produced, and identify the batch number, lot number, or control number of the finished batch of kratom product. Identification of the equipment and process involved in creating the batch. A record of the date and time of each batch made, as well as the maintenance cleaning and sanitizing of all equipment involved in the processing lines.
  • Traceability
    • Maintain clear records of the chain of custody and master records for any and all purchased/sold items with standard double verification. Establish and implement a supply chain system to allow a vendor to determine which customers receive any given batch and who/where the material used in that batch was initially supplied.

 

Adverse Event Reporting System and Recalls

  • Establish a written Adverse Event Reporting System in writing, in order to: 
    • Review all kratom product complaints in order to determine if the product complaint requires changes in procedure and/or manufacturing of the product, or a possible failure to meet the specific requirements involved in manufacturing that product.
    • Investigate product complaints that involve possible failure of the standards involved in manufacturing the product, particularly if it may cause illness or risk of injury.
    • Monitor any consumers who experience adverse health effects from a kratom product.
    • Monitor potential contamination or adulteration of kratom products, vendors selling counterfeit, contaminated or adulterated kratom products, including those who are labeling their kratom products or advertising their kratom products using false health claims.
  • Recalls
    • Establish and implement written recall procedures, perform random “mock recalls” according to procedure.

 

Marketing Practices

  • Labeling and Advertising
    • All labels, labeling and/or advertising of kratom products should not offer disease claims, structure/function claims, or reference any research or clinical data. 
    • Each finished product label must include a batch or lot number.
    • Finished products should be clearly labeled to disclose the mitragynine and 7-OH alkaloid content of any given product.
    • Every finished product label should advise consumers to contact their doctor for information relating to alkaloid values
    • No kratom products should be sold to individuals under 18.
    • Label should clearly state that no pregnant women should use kratom products during pregnancy.
    • All labels and advertisements must include the following statement: “This product is not intended to diagnose, treat, cure, or prevent any disease or condition.”

 

Compliance

All American Kratom Association companies are very strongly encouraged to adopt the above standards, and to implement a thorough and effective compliance program. This compliance program should include policies and procedures clearly outlined to foster compliance with the standards. Kratom vendors who adopt this code are encouraged to submit to AKA a certification that the company has adopted the code of standards above, and has implemented an effective compliance program. AKA will then publish the name of the online kratom company on its website, among a list of those companies that have passed a third party audit.