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FDA AND ISO QUALITY MANAGEMENT SYSTEMS

Certifications/Registrations

  • FDA Registered and Inspected for food processing and pharmaceutical API/Excipients

  • Manufactured in full compliance with FDA cGMP requirement for Finished Pharmaceutical and API.

  • Manufactured in full compliance with FDA requirements for Food Safety and HARPC.

  • REACH registered

  • Kosher Certified

  • ISO 9001

  • ISO 14001

  • Detrex Chemicals is REACH Registered
    and GHS Certified.

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Documentation/Validations

  • Master Validation Plan of Quality Management System QMS & SAP

  • Calibration program

  • QT9 Documentation Software

  • CAPA Program

  • Validated production process

  • Validated water systems

  • Validated analytical methods, systems and processes. 

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Full FDA Compliant Batch Documentation for all Customer Orders

  • Batch and lot production tracking

  • Full traceability of components/ingredients, from raw materials to finished product shipments to customers.

  • All internal analytical results periodically verified by accredited independent 3rd party laboratories.

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