Quality management system

Quality

To ensure our compliance we have developed a quality management system based on the cGMP: 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.
GMP certification

Certifications and authorization

  • Certifications: GMP certificate by the Spanish Agency for Medicines and Health Products (AEMPS).
  • Authorization: Manufacturer of sterile or biological active ingredients : Number of laboratory authorization 6594E.

Regulatory Inspections

US FDA and Spanish Medicine Agency (AEMPS) inspections.

AGENCY DATE SCOPE
AEMPS November 15 GMPs
AEMPS May 15 Anex, GMPs
AEMPS January 12 Anex, GMPs
AEMPS November 11 GMPs
USA-FDA July 11 GMPs
AEMPS September 08 GMPs
USA-FDA April 08 GMPs, Amoxicillin
AEMPS December 04 GMPs
USA-FDA October 03 GMPs, Cephalexin