
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Documentation system for historical reference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