QUALITY ASSURANCE

Quality Assurance

At Kegel, we understand the reputation of your brand holds tremendous value. This is why we put a high priority on ensuring that your materials are handled correctly, are monitored throughout the production process, and are tested to meet our high quality standards. As a manufacturer of products shipped worldwide for over 40 years, we have proven that we can deliver consistent quality to our customers.

We understand that your reputation is riding on our practices. That is why following GMP (Good Manufacturing Practices is a point of pride for us. We also adhere to the globally recognized quality standards.

  • FDA registered

  • EPA registered

  • GMP compliant

Key Points of our Quality Assurance Procedures

  • Rigorous vetting of suppliers/vendors

  • Incoming inspection of raw materials

  • Documentation system for historical reference

  • Validation of equipment, packaging and cleaning, including protocol reports

  • Sterilization of packaged materials

  • Visual inspection on manufacturing line

  • Material and batch traceability

  • Stability and expiration date traceability

  • Label control recognition

  • Thorough testing of every lot

  • Approved materials receive an authorization sticker

  • Facility Compliance

Quality Control

Rigorous quality control to meet specifications, highest level of quality, meet client’s quality and performance goals. Test in-house finished products. Kegel is registered with the U.S. EPA. Our staff is trained to comply with all applicable OSHA, DOT, IATA/ICAO, and IMO regulations. Additionally, they are HAZMAT shipping trained to comply with applicable dangerous good regulations.

Chemical Properties Checked

  • Tablet Hardness/Density

  • Tablet Weight

  • Bulk Density

  • pH

  • Specific Gravity

  • Viscosity

  • Container Weight

  • Solubility

  • Additional Specifications as requested by the client

Quality Control Tests Performed

  • Moisture Analysis

  • Color Matching

  • Solubility

  • Certificates of Analysis

  • Cleaning validation

  • Process valuation

  • Test method (analytical and micro) validation

  • Stability testing validation

  • FTIR

  • Additional Testing as requested by the client

COMMITMENT
TO QUALITY