The central goal of quality systems in CLB is to have consistent production of safe and effective products while ensuring that these activities are sustainable. We recognize that a robust quality system will promote process consistency by integrating effective knowledge-building mechanisms into daily operational decisions.

1. Management Responsibility

All managers at CLB demonstrate strong and visible support for the quality system and ensure its implementation throughout the organization.

• Provide Leadership
• Structure the Organization
• Build a Quality System to Meet Requirements
• Establish Policies, Objectives, and Plans
• Review the System

2. Resources

Appropriate allocation of resources is key to creating a robust quality system and complying with the cGMP regulations.

• General Arrangements
• Personnel Development
• Facilities and Equipment
• Control Outsourced Operations

3. Manufacturing Operations

The significant characteristics of the product being manufactured are defined from design to delivery, and control should be exercised over all changes.

• Design, Develop, Document Product and Processes
• Examine Inputs
• Perform and Monitor Operations
• Address Non-conformities

4. Evaluation Activities

Quality systems at CLB continually monitor trends and improve systems by monitoring data and information, identifying and resolving problems, and anticipating and preventing problems.

• Analyze Data for Trends
• Conduct Internal Audits
• Quality Risk Management
• Corrective & Preventive Actions
• Promote Improvement