Quality

 

To ensure our compliance we have developed a quality management system based on the ICH Q7: GOOD MANUFACTURED PRATICE  FOR ACTIVE PHARMACEUTICAL INGREDIENTS.

> Competence of Unit

 

  • GMP and Legislation Compliance
  • Regulatory Affairs
  • Processes Validation
  • Cleaning Validation
  • Analytical Method Validation
  • Supplier Validation
  • Quality System Improvement
  • GMP Training
  • Audit
  • Customer Support
  • Support to Operations, Marketing and R&D
> Certifications
  • Certificacions
    • ISO 9001-2008 Certified
    • GMP's Certified by National Health Authority (AEMPS)

 

> Regulatory Inspections
US FDA and Spanish Medicine Agency (AEMPS) inspections
Agency Date Inspection
FDA
February 93
Amoxicillin, GMP
FDA
November 95
Amoxicillin, Ampicillin and Cephalexin, GMP
Spanish Health Ministry
December 96
GMP
FDA
October 03
Cephalexin, GMP
AEMPS
December 04
GMP
FDA
April 08
Amoxicillin, GMP
AEMPS
September 08
GMP
FDA July 2011 Amoxicilina, Ampicilina, Cefalexina y GPM
AEMPS November 2011 GMP