Nucleic Acid Chemistry

Quality Assurance and Quality Control

Quality Assurance - HPLC MSDocumentation 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.

CONTACT US

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

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

Enhanced Quality

The Enhanced Quality Program (EQP) has been introduced by Sigma-Aldrich to provide customers with an integrated supply chain and quality system which addresses the industry's critical manufacturing requirements in terms of quality certification, documentation and change control notification. Under EQP, selected Quality levels are linked to specific products in order to assure that the required standards are guaranteed.

Visit the Enhanced Quality Program page for more details.


Change Control Notification Program (CCN)

CCN mitigates the inherent risk associated with 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

Place your request directly with your sales representative or at our Quality Services Group.