Good Manufacturing Practice (GMP)
From formulation to distribution, Zemvelo products are designed and controlled for the maximum health and safety of our consumers. As such, the quality of our products is controlled at every step of the product life-cycle, including quality ingredients from vetted and responsibly sourced suppliers and a manufacturing process that exceeds FDA and industry standards for quality. We employ current Good Manufacturing Practice (cGMP) to ensure the integrity of our products and the associated production processes.
Our Quality Unit works with other departments to consistently review and evaluate manufacturing, packaging, labeling, and warehouse operations for compliance with government regulations, industry standards, and customer requirements. Together, we utilize best practices and implement improvements as needed.
Our commitment to quality is also reflected in our personnel, who pride themselves in safe and compliant work practices. A comprehensive training program is in place to equip all employees with hands-on training and to deliver routine GMP training for continuously increasing compliance.
Each Zemvelo product is built according to a pre-approved formulation and a master manufacturing record that includes product and process-specific controls for reliable and reproducible results. We also monitor critical process controls for optimization of our production procedures.
Production equipment is qualified for its intended use prior to implementation in the manufacturing or packaging process. Following qualification, equipment is entered into a preventive maintenance plan to ensure safe and acceptable operation for the life of the equipment.
Raw materials, in-process and bulk products, and finished products are tested according to scientifically valid methods and specifications. Materials and products are only released for use upon successful completion of the required testing. Lot-specific Certificates of Analysis are issued for finished product lots that meet the specified limits for release and distribution.
Zemvelo products are built on a foundation of quality with a focus on effectiveness for the consumer. The result for our customers is trustworthy products from a company that is delivering HOPE.
Zemvelo Product Quality Control Inspection & Testing Procedures
Our Vendor Qualification Process
Want to join the Zemvelo family? Learn more about how you can sell our high-quality products through Wholesale or White Labeling.
Factory Business Background Investigation
This process includes checking the company’s financial assets and background, an investigation into compliance with labor laws, and operations compliance issues. We investigate the number of years in business, other products made at their facility, operations to make the ingredients that are outsourced, frequency of audits, last audit date, and finally, FDA or governmental enforcement actions (includes 483, Warning Letter or other).
Factory Licenses and Certifications Investigation
This includes documentation of business licenses; ISO 9001, ISO 22000, cGMP, HACCP, HALAL, Organic certifications, and Non-GMO certifications along with any other certifications; and adherence to USP-NF monographs and Food Chemical Codex standards.
Onsite Factory Inspections
As part of our supplier partner selection process, we conduct a factory audit, either in person or through a representative of Mineralife. This audit begins with the physical inspection of the plant, onsite interviews, and inspection of the factory’s quality control systems. It also includes the physical inspection of products to be purchased and the taking of samples for analysis by our own QC team.
In-House Lab Testing
Product samples are obtained and sent to our Mineralife facility for testing, inspection, and product analysis in our in-house laboratory. R&D and test batches are created for conformity to our process methods and desired end-use.
Product samples are sent to a third party U.S lab for identification, Assay, Heavy Metals testing (lead, arsenic, cadmium, and mercury), microbial testing for total plate count, yeast, and mold, E.Coli, Salmonella, Staphylococcus Aureus, and Coliforms, to verify the accuracy of the factories product specifications.
Samples of each batch of ingredients shipped to Mineralife are kept one year past shelf life after finishing the QC process. We have developed a testing program at Mineralife that seeks to ensure that the ingredient manufacturer’s claims of product shelf life and potency are accurate. We continue to monitor ingredient quality long after we have actually used the ingredient. We want to be sure of the long-term quality of the ingredients we use and the suppliers we partner with.
Our ingredient and component suppliers are required to go through a requalification process. We do this to ensure nothing has changed with our chosen supplier that may affect the quality of their products.