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Frequently Asked Questions

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GMP Certification Program

Do you have questions about our GMP Certification Program? Well, we have the answers. Don't see your question? Contact us! We're here to help!

What are the benefits to becoming KVA GMP Certified?

The benefits of becoming KVA GMP Certified extend far beyond a seal on your website and your logo on our website (although those are great, too!). Becoming KVA GMP Certified not only shows your customers that you are compliant with GMPs, but it also shows that you care about product quality and consumer safety. Additionally, you will learn about GMP compliance and will better understand your business because of it. 

How long does it take to complete the GMP Certification Program?

The amount of time you take to complete the process of becoming KVA GMP Certified will be unique to your situation. There is no standard time period. Please note that the Advisory Board meets monthly, so there may be some wait time (days/weeks).

Do I need to be a KVA member to apply? If so, how much does it cost?

Yes, we require KVA membership. We want to be sure you have access to all the resources you'll need to become GMP compliant. Membership is available for $2000 (just $5.50 per day!). See membership benefits >> 

How much does the GMP Certification cost?

We do not charge a fee to become certified; however, there is a non-refundable application fee of $150. This fee is for the Preliminary Review portion of the GMP Certification Program. See the application process >>

Are there any additional costs to become GMP Certified?

You will pay a fee for the audit of your facility. KVA Certified Auditors are not permitted to charge more than $1600 total. You may have additional costs if you need SOPs, one-on-one assistance from a compliance specialist, and/or training (such as GMP training). The KVA has all the resources you'll need!

Why don't you charge a fee to become GMP Certified?

The KVA knows the financial struggles of kratom vendors. We prefer you spend your revenue on products and services that will IMPROVE YOUR BUSINESS, not ours! We offer many resources through our membership so you can improve and grow your business.

What is the purpose of the Preliminary Review?

The purpose of the Preliminary Review is to learn about your business and review SOPs and related documentation to determine if your company has any major or "glaring" compliance gaps. After the review, you will receive a list of any major compliance gaps and suggestions for fixing the gaps. This gives you time to make changes and get ready for your audit. We do not want you to get audited only to fail in the end!  See the application process >>

Can I choose my auditor?

No, the KVA does not permit vendors to acquire their own auditors. We have a rigorous process for acquiring the most suited, certified auditors for your business. As compliance specialists, we know what to look for when selecting an auditor. In addition, we want to be sure there is no conflict of interest between you and the auditor. See auditor qualifications >>

What is an audit and how does it work?

The purpose of the KVA audit is to determine your compliance with 21 CFR 111. Your auditor will do that by speaking with you, interviewing your employees, taking a virtual tour of your facility, and reviewing SOPs, policies and related documentation, such as batch records, training records, and logbooks. After the audit, the auditor will review any noted observations (non-compliances) with you. At that time, you will have the opportunity to respond to the observations. Once in agreement, the auditor will send an audit report to you. That same audit report is submitted to the Advisory Board for review and preparation for the Advisory Board Meeting where they will vote on your acceptance into the GMP Certification Program. 

How do I prepare for the audit?

We have created the Roadmap to GMP Compliance to provide guidance on getting audit-ready. We encourage you to use it to prepare for the GMP Certification audit.

Which regulations will be used to audit my company?

Your appointed KVA Certified Auditor will audit your company using 21 CFR 111 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. 

What is an Advisory Board and why do they determine my acceptance?

The purpose of the Advisory Board, in regards to the GMP Compliance Program, is to review the audit report, and speak with you, the vendor, to determine if you are compliant with 21 CFR 111 and understand GMPs. Advisors are not paid by the KVA. The KVA has appointed the task to the Advisory Board to avoid conflict of interest. 

I'm already AKA GMP Certified, do I need KVA GMP Certification?

No kratom vendor needs to be GMP Certified. Period. But if you want to be competitive and show your customers (other kratom vendors and the FDA) your commitment to GMP compliance, product quality and consumer safety, you will choose our GMP Certification Program.

 

Our GMP Certification Program was designed by compliance specialists who know the kratom industry. The robust process was specifically designed to weed out the "basement" vendors. 

Is the KVA affiliated with the AKA?

While the KVA is not directly affiliated with the AKA, we do, however, support with their efforts to legalize and regulate kratom. We applaud their efforts and believe that the KVA and AKA are complementary to each other. Support the AKA >>

When do I get my KVA GMP Certified Seal and how can I use it?

Once the Advisory Board approves your GMP Certification, the KVA will issue the GMP Certified Seal to you. You may use it on all your marketing materials, packaging, labels, website, and social media as long as you remain a certified KVA member.

What happens if I don't maintain my KVA Membership?

Vendors must maintain annual KVA Membership for the duration of the GMP Certification period (one year). If your KVA Membership lapses, you will be removed from our website and disallowed use of the KVA GMP Certified Seal. Violators will be banned from the KVA website and GMP Certification Program.

Do I have to re-certify? If so, how often?

The KVA GMP Certification Program is valid for one year at which time you may re-certify to continue with the Program. If you choose not to re-certify, you must remove our GMP Certified Seal from all your marketing materials. You will also be removed from the KVA website. You may, however, continue your membership and use our services and products.

How do I re-certify?

Vendors may re-certify when their certification has expired. The re-certification process is the same as initial certification, but typically the process progresses more quickly than initial certification.

Can I be rejected from the GMP Certification Program?

Vendors must remain in compliance with GMPs during the 12 months in which the certification is active. Additionally, vendors must follow FDA labeling guidelines. They must also maintain their KVA Membership. The Advisory Board is responsible for determining a vendor's status in the GMP Certification Program. If you are rejected from the Program, you must remove all usage of the KVA Seal.