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.
- Customer Support.
- Support to Operations, Marketing and R&D.
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.
US FDA and Spanish Medicine Agency (AEMPS) inspections.
|AEMPS||May 15||Anex, GMPs|
|AEMPS||January 12||Anex, GMPs|
|USA-FDA||April 08||GMPs, Amoxicillin|
|USA-FDA||October 03||GMPs, Cephalexin|