SYNTHETECH OFFERS:

     Synthetech also undertakes
     custom synthesis of advanced
     intermediates and APIs following
     cGMP
guidelines.

     Click Here for our Specialty Amino
     Acid Price List.
     
     Industry Affiliations:

   

       www.dcat.org

   

          ISO 14001:2004

Synthetech, Inc; Albany, Oregon Registered to ISO 14001:2004.Certificate Registration No: 10000190 UM.

 


Quality  /  EHS&S

Quality Objectives and Targets for 2011

Synthetech has always been committed to delivering high-quality products to our customers.  To ensure that our customers' quality expectations are met, Synthetech has now developed a comprehensive cGMP environment for manufacturing large-scale advanced intermediates and early-phase APIs. This has been demonstrated by the development of quality systems that promote the manufacturing of superior pharmaceutical intermediates and ensure that our final products are delivered on time and within specification.  Several recent customer audits have resulted in cGMP intermediate and early-phase API qualification. 

Synthetech is also proud to offer products that are of non-animal/human origin.  It is our standard to offer origin certificates as part of an order.

Synthetech manufactures our products under a cGMP-based Quality System.  Within this system, the cGMP application is strengthened as the product moves from development to launch.  By working closely with our customers, Synthetech builds quality into our processes as appropriate to the products development or manufacturing phase, and to ensure the customer's quality needs are met. 

By using sound procedures, following proper documentation practices, designing adequate equipment, facilities and instruments, using quality raw materials, and having the right people to complete the task correctly, Synthetech consistently delivers products of superior quality. 

We welcome you to visit our facilities and would be glad to provide additional information about our quality systems and analytical capabilities.



Quality Assurance
  • Proactive Quality Management through our Quality Systems
  • cGMP/ICH Q7A Compliance for Intermediates and early-phase APIs
  • Final Review/Release
  • Vendor Approval
  • Documentation: Approval/Control
  • Specifications
  • Validation
  • Audits
  • Training
  • Controlled Change
  • Root Cause/Corrective Action

Quality Control

  • cGMP Compliance for Intermediates and early-phase APIs 
  • Final Product, Intermediate, In-Process, and Raw Material Analytical Testing
  • Instrument Qualification and Calibration
  • Method Transfer/Validation
  • Stability Storage & Testing
  • FDA Registered Lab


 

Analytical Capabilities

  • LCMS/GCMS
  • HPLC/DAD/ELSD/FLD
  • Chiral HPLC/GC systems
  • GC/FID/PID/ELCD
  • FT-IR Spectroscopy
  • Spectrophotometer
  • Auto-Titration Systems
  • TLC Analysis
  • Polarimeter
  • Moisture / KF Analysis

      Access to:

  • NMR
  • Elemental Analysis
  • Trace Metal Analysis