Mission

We aim to fulfill our mission to be an independent European leader in contract manufacturing contract packaging and clinical trial services of non-sterile products by

• Maintaining a high degree of innovation
• Delivering superior quality
• Delivering excellent service and flexibility

We will
• Commit ourselves to the highest current quality standards
• Focus on 100% contract manufacturing
• Try to be the most effective contract manufacturing company at managing product flow and product quality
• Invest in the best available technology to build a strong and flexible organization
• Train our people to support them in their duties and skills
• Invest in high SHE-standards to keep our people and environment healthy

Corresponding to our mission statement, the QA-division assures a constant
and high level of quality.

Our Quality Management System is maintained by the Quality Assurance Department, which is independent from 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
• 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

The Quality System is designed to comply with the Rules Governing Medicinal Products in the European Union of the European Commission and with specific requirements as agreed with the individual customers.