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KVA GMP Certified

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The most important part of your business is quality control, and that's why it's so important to become GMP Certified. Good Manufacturing Practices (GMP) certification gives kratom vendors a strong reputation as a trustworthy and responsible vendor.

 

KVA GMP Certified means that the kratom vendor has completed a very rigorous certification process in which their kratom business was critically evaluated for compliance to GMPs by a carefully selected KVA American Society for Quality (ASQ) Certified Auditor. Kratom vendors who have achieved GMP Certified status from the KVA have demonstrated a passion for product quality, concern for consumer safety, and strive for excellence. It is important to note that GMP Certification refers to the business practices of the vendor; it does not refer to the quality of the product.

What Does it Mean to be GMP Certified?
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Quality Unit

Kratom vendors have a Quality unit separate from the manufacturing / production unit to avoid conflict of interest. The Quality unit provides the checks and balances of the manufacturing operations. The Quality unit has the authority to quarantine, release or reject a product batch. The Quality unit  reviews and approves documentation.

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Personnel

All personnel have the qualifications to perform their job. They have completed GMP training and wear personal protective equipment (PPE), such as gloves and gowning garb, when performing manufacturing and filling operations. Personnel follow hygienic practices, such as hand washing, to prevent contamination to the kratom products.

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Manufacturing

The kratom vendor must have manufacturing controls in place to ensure the kratom product is produced consistently from batch to batch. A second person verifies each critical manufacturing step to ensure accuracy and completeness. The Quality unit reviews and approves all documentation, including batch production records.

Facilities

The kratom manufacturer has adequate facilities for manufacturing, holding, and/or distributing products. A proper pest control program is in place to prevent rodent infestation. Proper hand washing and bathroom facilities are available to employees. The grounds around the facility are maintained to prevent contamination.

Specifications

Vendors have specifications (or control limits) for their kratom products, packaging and labeling to ensure every product batch and component meet GMP regulations for quality and safety. Products and components not meeting GMP standards are rejected by the Quality unit to protect the consumer. 

Product Testing

The vendor collects representative samples of kratom and submits them  to a qualified testing lab for microbiological testing.This ensures product safety. Kratom products are also tested for the presence of heavy metals, such as lead and arsenic, and impurities. Kratom product that fails any of the testing is quarantined and investigated by the Quality unit. 

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Equipment

Equipment, instruments and utensils are cleaned and maintained to prevent microbial contamination. Equipment and instruments have logbooks documenting preventative maintenance, calibrations, weights, cleaning and use. Instruments are precise and calibrated before used. Logbooks are reviewed by the Quality unit to ensure processes are in control

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GMP Audit

The kratom vendor has undergone a thorough audit by a KVA ASQ Certified Auditor to determine conformance to SOPs and compliance with GMPs. The facility was toured during production activities and personnel were interviewed. The facility, equipment, processes, and personnel were evaluated against GMPs. 

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Cleaning & Sanitizing

The kratom vendor has a cleaning and sanitization plan in place for controlling microbial contamination. They have procedures and processes in place to prevent cross-contamination. Surfaces are tested for microbial contamination  after each cleaning event to ensure cleaning procedures and processes are effective at removing microorganisms.

*The statements above are representations and based on compliance with 21 CFR 111; they are not specific to, or representative of, any vendor, person, or organization. KVA makes no claims or guarantees that vendors completing the GMP Certification Program are currently in compliance with GMPs. Note: An audit is merely a snapshot in time and may not be representative of activities at other times.