The Quality Assurance department assists all production departments in the development of quality systems and performs periodic audits to ensure that these systems are implemented accurately, efficiently and in accordance with the regulatory requirements established in FDA-GMP and 21 CFR Part 820. Quality Assurance is responsible for:

• Online data verification
• Routine Process Audit
• Internal audits
• Internal quality control
• Participation in proficiency testing programs
• Addressing customer complaints and comments

Costarica has developed over 700 SOPs to meet the quality system requirements

The SOPs find their application in the following:

• Safety criteria
• Sampling and sampling techniques
• Sample storage, transport, and disposal
• Product-based testing
• Quality of consumables and reagents
• Use, maintenance, and calibration of equipment
• Selection of test methods and method validation
• Measurement of the degree of uncertainty for analytical techniques
• Document control
• Training
• Quality Assurance procedures for different areas
• Reference Standard maintenance
• Calibration procedures and schedules
• Proficiency testing and Inter-laboratory comparisons
• Internal quality control, etc.

Costarica believes that total quality involves integrating every aspect of its operations into quality Management through:

• Customer delight
• Involvement of employees in quality improvement
• Standardization of procedures
• Continuous training for employees
• Maintenance of sample integrity
• Continuous improvement through customer feedback