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