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Quality and compliance

Every project,to standard.

Bio Pure executes projects in compliance with the international standards that govern pharmaceutical and food process systems.

Standards we work to

  • cGMP
  • USP
  • FDA
  • ISPE
  • ASME BPE
  • DIN
  • ASTM
  • 3-A
  • EHEDG

Documentation

Qualification package

We provide comprehensive documentation for project compliance, prepared alongside the work rather than after it.

  1. FATFactory Acceptance Test
  2. SATSite Acceptance Test
  3. DQDesign Qualification
  4. IQInstallation Qualification
  5. OQOperational Qualification
  6. PQPerformance Qualification