Quality Management

The Sanico Quality Management System is maintained by the Quality Assurance Department, which is independent from the other operational departments of Sanico and consists of the following sub-divisions: QA Validation; Documentation, QA Compliance, QA Regulatory Affairs and QA Administration.

The system includes the following parts:

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

The Quality System is designed to comply with the Rules Governing Medicinal Products in the European Union of the European Commission. Sanico is subject to FDA inspections and has therefore also to comply with the US CFR Title 21 ‘Food and Drugs’ and with specific requirements as agreed with the individual customers.

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