Quality
Rohm and Haas is committed to manufacturing bulk pharmaceutical chemicals of consistent and uniform quality in compliance with current Good Manufacturing Practice (cGMP) standards, and with the latest requirements of regulatory authorities. The processing, packaging, labelling and control operations for all of our pharmaceutical grade resins are carried out by Rohm and Haas France's SAS facility, located in Chauny.
• FDA inspected in 1995, 1997 and 2001
• ISO 9001 certified
• ISO 14001 certified
• ISO 18001 certified
• AFSSAPS (2006)
Assistance is also provided to customers in preparing regulatory submissions. Chemistry, Manufacturing and Controls (CMC) Documentation is available for each of our pharmaceutical grade resins, for your review and/or inclusion in your Marketing Authorization Applications.
For U.S. applications, Rohm and Haas has filed appropriate Drug Master Files (Type II and Type IV DMF) with the Food and Drug Administration. Letters of Authorization and CMC will be issued and provided upon request.
For more information, please contact your HealthCare Quality Assurance Manager, Ms Noel Hetrick.
