Certifications

Customer safety is at the forefront of our operations.

We meticulously inspect raw materials and test products throughout the manufacturing process to ensure consistent quality.

Biogenesis is registered with the FDA as a manufacturer and packager of Over-The-Counter (OTC) products.

We adhere to cGMPs pursuant to 21 CFR parts 211 (Current Good Manufacturing Practices for Finished Pharmaceuticals) in the manufacturing of the products produced at our facility.

As a registered establishment, we are subject to the statutory inspections by the FDA and by the Quality Assurance Departments of our clients to verify compliance with cGMPs.

 Biogenesis ensures Product and plant Quality through the implementation of the following processes & Procedures:

  • Product Inspection
  • Qualification and audits by third-party laboratories
  • Method development and validation
  • Forced degradation studies
  • Final product release testing
  • Dosing solution analysis for OTC
  • Environmental Monitoring Program
  • Cleaning/Sanitization Program Upgrades
  • Cross-contamination prevention
  • Equipment Upgrades and maintenance
  • All raw materials entering our facility undergo meticulous inspection

ISO Certification

Biogenesis is ISO 22716:2007 certified .  Certification to ISO 22716 provides compliance to all of the recommendations of the Cosmetics GMP Guidelines through its approach to documentation and regulation of the production, control, conditioning, storage, and shipment of product.

Biogenesis is registered to provide products for U.S.A., Canada, China, Europe, Australia and Japan. Our  core capability is in skincare: specializing in products such as anti aging face care, body care,,color hybrid beauty cosmetics, Acne  & SPF products.