GMP Certification Program
GMP Certification Program
About Our Program
The KVA offers GMP Certification to kratom vendors who are KVA members doing business in the United States ONLY. Our GMP Certification Program requires compliance with 21 CFR 111 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Questions?
GMP Certification Cost
At this time, we do not charge a fee for GMP Certification. However, we do charge a small non-refundable application fee ($150) to apply. This fee covers the cost of the preliminary review of your application.
KVA Membership Required
KVA membership is required to become certified so you have access to all the resources you'll need to become GMP compliant. Membership expires one year from join date. You must maintain KVA membership to maintain your KVA GMP Certification. Membership and GMP Certification renews annually.
KVA Certified Auditors
All audits are performed by KVA Certified Auditors. Our KVACAs must go through a rigorous vetting process prior to performing audits of Kratom vendors. KVACAs must be ASQ certified, have at least ten years' experience in a regulated industry, and have at least five years' GMP auditing experience. See KVA Certified Auditors page.
KVA Advisory Board
Our Advisors have been personally selected by the KVA Founder, and each bring their own unique knowledge, experience and education.
To avoid conflict of interest, Advisors are not employed by the KVA. Therefore, their voting decisions are their own based on their experience, understanding of the KVA GMP Certification Program, the KVA mission and GMPs.
Learn more about our Advisory Board.
The Application Process
1
Join the KVA
KVA Members ONLY are eligible to apply to our GMP Certification Program. Membership includes free and discounted resources you'll need to become GMP compliant, such as one-on-one GMP compliance assistance, SOPs, GMP training courses, and much more.
2
Identify GMP Gaps
Now that you have access to all the KVA resources, you can determine your state of compliance. Use The Roadmap to GMP Compliance to identify GMP compliance gaps. Or, if you feel you're ready, submit your application.
3
Submit Your Application
When you're ready, complete the GMP Certification application and submit the $150 non-refundable application fee. A survey will follow to determine your state of compliance with GMPs. Once we receive your survey, a KVA Certified Auditor will perform a preliminary review.
4
Preliminary Review
The purpose of the preliminary review is to determine any major GMP compliance gaps. The results of our preliminary review will be emailed to you. If we find major gaps in GMP compliance, you will receive a list of tasks to complete and resources you'll need.
5
KVA Certified Auditor Assigned
Once you think you're audit-ready, contact us and we will match you with a KVA Certified Auditor. The KVACA will contact you to schedule and perform the audit. It is your responsibility to pay the auditor's fee. KVACA are not permitted to charge more than $1600 total for the audit.
6
GMP Audit
Your KVACA will request access to your documents (SOPs, etc.) 24 hours prior to the audit. This allows the KVACA to review documents and prepare questions. The audit is performed virtually via videoconferencing. You will provide a virtual tour to the auditor during which time the KVACA may interview personnel. The audit will be completed in one day. At the conclusion of the audit, you will be informed of the results (audit observations) and standing (pass/fail) and will receive an audit report for your files.
7
Advisory Board Review
Once your audit is complete and you've resolved any observations, you will meet with our Advisory Board. (AB meetings are held monthly.) During the meeting, you will introduce your company to the AB and answer any questions. The KVACA will present a summary of the audit observations and remediation activities to the AB. The AB will then vote to approve entrance to our GMP Certification Program or recommend further remediation.
8
KVA GMP Certified Seal
Upon approval, you will receive the official KVA GMP Certified Seal, which you may place on all marketing materials, including your website, packaging, etc. You will also receive a certificate and be listed on the KVA website as a GMP Certified vendor.
KVA Membership Benefits
We offer a wealth of resources for kratom vendors! Become a member today and get FREE and discounted SOPs, training courses, and one-on-one assistance. Join Now >>