Our quality system

Sanico’s quality system complies with the EC Rules Governing Medicinal Products in the European Union and is subjected both to local (FAMHP) and international (FDA, ANVISA, SFDA) audits.

The Sanico quality system includes:

• Maintaining general cGMP-compliance
• Cleaning, process and equipment validation
• Execution and follow-up of internal and external audits
• Equipment calibration
• Complaint handling
• Training follow-up
• Change control management
• Product quality review
• Batch release
• Master and executed batch record generation
• Deviation handling
• Regulatory affairs
• SOP review
• Stability follow-up