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Quality Assurance and Quality Control

Documentation and change control adapted to diagnostics and pharmaceutical applications

Proligo® Reagents are manufactured under a strict quality system. All key intermediates are controlled with stringent in-process controls and/or quality specifications in order to exercise maximum control on final product quality. In-process controls are established for critical parameters while manufacturing processes are constantly monitored and routinely reviewed. A dedicated process technology group provides the basis for continuous improvement.

We have over 30 years of experience supplying diagnostic and pharmaceutical industries, during which it has conducted a history of successful site audits.

Quality Assurance

Compliant raw materials with the right documentation

  • ISO 9001 certified since 1993
  • Consistent high quality products
  • Traceability of all processes
  • Continuous process improvement
  • Product data RP HPLC, NMR
  • Product testing
  • UV/VIS tests performed on finished products

State-of-the-art analytical methods

  • LC-MS
  • NMR (31P, 1H, 13C, 19F)
  • FT-IR
  • Titration & "Wet Chemistry"
  • UV/VIS
  • Karl Fischer water analysis
  • Mercury porosimetry

Change Control Notification Program (CCN)

CCN mitigates the inherent risk associated with a stable and reliable supply. The program is available with quality agreements in place and commits to notify customers of changes related to:

  • Manufacturing
  • Specification
  • Critical packaging components
  • Vendors of critical raw materials
  • Site of manufacturing / packaging
  • Storage temperature
  • Product origin
  • Retest periods
  • Product deletion