Quality and Compliance

A Commitment to Quality, A Record of Success

When you choose Confab as your contract pharmaceutical development and manufacturing partner, your work will be held to the highest quality standards. Our quality team works closely with you to monitor all key activities, anticipate your needs and investigate challenges and opportunities to provide solutions that ensure your success.

Our quality team provides GMP oversight by administering quality systems and best practices concerning elements such as corrective action and preventive action (CAPA), complaints, applied pharma research (APR), training deviations, stability testing and internal audit programs.

Review Board

To ensure continuous compliance and improvement of quality systems, we present key compliance and quality indicators to upper management monthly. This includes measurements on adherence to inspection and audit commitments, non-quality indicators and adaptions to changes in regulation. By doing so, Confab is better positioned to help you succeed.

Continuous Improvement

Lean Lab

  • CAPA system
  • Standard working instructions
  • Data review and OOS management
  • Competence matrix
  • Qualification and calibration of instruments
  • Visual management tools
  • Quality performance

Operational Excellence

  • Inventory management
  • Visual management tools
  • Quality performance
  • Planning systems
  • Packaging operations

Compliance

Confab’s outstanding regulatory compliance record serves as the foundation of our organization. Our management team has years of experience in pharmaceutical manufacturing for international markets and regulatory affairs. We provide oversight of regulatory compliance by administering a meticulous internal audit program, and we provide support for regulatory and client inspections and vendor auditing activities. A comprehensive set of standard operating procedures guides all key activities and keeps us compliant with the U.S. Food and Drug Administration (FDA), Health Canada Establishment License, European Medicines Agency (EMA), Customs-Trade Partnership Against Terrorism (CTPAT), narcotic license, precursor license, site license for dietary supplement and foreign markets.

Our focus on continuous training and investment in quality systems ensures that products developed and manufactured at Confab live up to the most rigorous quality standards.

Regulatory Accreditations

  • Health Canada Establishment License
  • FDA approved
  • Mutual recognition with EMEA countries