We believe in trust and transparency. We want you to trust in our quality manufacturing processes and safety regulations. Independent third-party validation of our cGMP certifications and compliance give you assurance that we indeed manufacture to the highest quality standards.
cGMP stands for Current Good Manufacturing Practices. Registration and compliance is enforced by the Food and Drug Administration Code of Federal Regulations, Title 21, Part 111. The code scopes the monitoring and regulation of proper manufacturing procedures, packaging, labeling, or holding operations for dietary supplements. Our compliance ensures that manufactured supplements are consistently safe and pure.
As part of the independent GMP registration process, NSF International, one of the most stringent third-party testing organizations, conducts an extremely comprehensive audit that includes inspection of our manufacturing facility, product testing, process control, employee training, raw material specification and control, facility and equipment maintenance and much more. This process is all-inclusive and voluntary. We did this to demonstrate to our clients and to the market that we hold ourselves to the most stringent standards of safety and quality.
The Natural Products Association (NPA) was the first industry organization offering a third-party GMP certification program for the manufacture of dietary supplements. Biovation Labs is proud to be an annual member of this organization and adhere to GMP standards of manufacturing excellence.
OK Kosher compliance certifies that products manufactured by Biovation Labs meet a strict policy of kosher food laws including cleanliness, purity and quality. A process of regular inspections by a rabbi are conducted to verify the kosher status of a product and the facility is warranted and guaranteed.
Biovation Labs conforms as an FSRN GMP Health Canada annex facility that consistently produces and controls quality good manufacturing practices and standards appropriate for the manufacture of dietary supplements.
Every contract manufacturer touts’ quality. And of course, those that are GMP certified are audited to meet certain quality standards. But are there differences?
Yes! There are differences in the level of quality—even among GMP manufacturers.
For instance, examine the frequency of Biovation Labs trained Quality Control Staff inspecting each stage of the manufacturing process. These are trained and qualified QC Staff—not simply machine operators. Processes may require every 15-minute inspections, hourly inspections, or even greater frequency. That is virtually unheard of with most other manufacturers, whom typically inspect only every 60 minutes (or more). More Inspections = Higher Quality.
We believe critical steps in contract manufacturing require more rigorous quality controls and procedures. Again, a difference in the level of quality. For example, in the manufacturing steps of ingredient weighing and batch blending, Biovation Labs requires double-verification by two separate individuals to ensure proper materials and weights are met for each product batch. Double Verification = Higher Quality.
At Biovation Labs our clients know they can trust our great manufacturing processes to produce a higher level of quality supplement manufacturing. Highlighted below are a few more examples of how our team delivers on creating exceptional supplements for you and your customers.
Each vendor is validated to ensure Biovation Lab quality standards are met at the raw material and ingredient level.
Each incoming raw ingredient is kept under quarantine until quality control testing is completed and passed.
Proper apparel protects product and employees from potential contaminants and adverse exposure.
Quality control staff ensure personal protective equipment is worn properly and at all times by those in production areas.
Documentation details the amounts of material required for each batch. Each ingredient is weighed by one individual then verified by a second individual.
Weighing rooms are inspected and swab tested for contaminants prior to every batch, and approved by quality control staff for production.
Double-verified raw material batch weights create a chain of quality controls allowing a product batch to then stage for the blending process.
Double-verification of weighed ingredients for the supplement batch formula is performed to ensure correct materials and weights are blended into each product.
Blending rooms are inspected and swab tested for contaminants prior to every batch, and approved by quality control staff for production.
Every 15-minute inspections are performed to verify capsule weights and check for potential defects.
Hourly quality control checks also verify capsule weights and inspect for any possible defects.
Encapsulation suites are inspected and swab tested for contaminants prior to every batch, and approved by quality control staff for production.
Quality control staff inspect filled capsules for polishing, removal of defects, and to verify quality prior to packaging.
The inspection room is checked and swap tested for contaminants prior to each batch, and approved by quality control staff for production.
Quality control staff perform a multi-point capsule inspection of each supplement barrel contents prior to release to Packaging.
Each barrel of finished capsules is double-verified by both the Line Lead and quality control staff before staging for final product packaging.
Packaged bottles receive a double-seal for safety, cotton (if requested), product label, and/or a retail box.
Every 15-minute quality inspections and hourly QC inspections ensure proper capsule count and check for any packaging defects.
Final product production is inspected, reviewed and released by quality control staff before exiting the Packaging area for fulfillment & shipping.
Quality control performs skip-lot inspections of raw materials as well as finished goods—sending the product to the lab for Biovation Labs group of quality tests.
Whether your product is at a mature stage or a formative stage – we leverage our experts and capabilities with relevant marketplace guidance and validated quality manufacturing to help speed your product to market. Contact us now, tell us what you need, and let’s grow success.