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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 complying with the latest requirements of the regulatory authorities.
The processing, packaging, labelling and control operations in the production of all our pharmaceutical grade resins are carried out by Rohm and Haas France SAS facility located in Chauny.
• FDA inspected in 1995, 1997 and 2001
• ISO 9001 certified.
• ISO 14000 certified.
Assistance is also provided to customers with preparing regulatory submissions. Chemistry, Manufacturing and Controls (CMC) Documentation is available for each of our pharmaceutical grade resin for your review and /or inclusion in your Marketing Authorisation Applications.
For US applications, Rohm and Haas has filed with the Food and Drug Administration appropriate Drug Master Files (Type II and Type IV DMF). Letters of Authorisation and CMC will be issued and provided upon request.
For more information, please contact your WW Quality Assurance Manager, Ms Sylvie Fokin.