Dear customers,
We would like to inform you about the removal of the cGMP statement on the quality assurance certificates for Sartorius Separation Technology products.
Since Sartorius Separation Technology products are not pharmaceutical goods or drugs in themselves, the cGMP statement on QA certificates might be confusing.
Sartorius hereby confirms that the basis for ensuring product quality and safety is complete compliance with the implemented and certified ISO 9001 quality management system. Within this quality management system, a risk-based approach is applied, comparable to cGMP requirements for process development and control and quality measures.
As customers, you will not notice any changes in the safety and quality of the product or in the service resulting from the adjustment of the quality assurance certificate. This change will also be successively adapted in other documents, such as validation guides.
This change will apply from April 2023.
For more information about the mentioned change, read the Sartorius official document, but see below the list of products affected by the change.