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.

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

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