GE Healthcare Life Sciences provides regulatory support, such as regulatory support documentation and change control notifications (CCN), to customers using our products and services in regulated environments.
As a subscriber to Regulatory Support you will receive email notifications when the documents are updated with new information or when a new change control notification is published.
GE Healthcare recognizes the importance of supplying information to support our customers in fulfilling regulatory requirements. The statements listed below provide information on the ingredients used in the manufacturing of GE Healthcare BioProcess chromatography resins.
The statements primarily concern BioProcess chromatography resin products and are applicable to products aimed for use in GMP environments. The information contained in the statements has been obtained from our material suppliers.
GE Healthcare assures that purchases of materials conform to specific requirements and that materials are acquired from qualified suppliers. This is achieved through working closely with our suppliers and through a robust qualification process and supplier monitoring process, including continuous supplier audits for materials essential to function.
Download statements for BioProcess chromatography resins
Aflatoxin
Allergens
Genetically Modified Organisms
Halal and Kosher
Latex
Melamine Contamination
Metal Catalysts and Reagents
Site of Manufacture
