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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