Manufacturing Practices. 10.1 SUNEVA is responsible for ensuring that all Products are designed and manufactured in material compliance with cGMP, including FDA’s Good Manufacturing Practices, which are now codified in the Quality System Regulation (“QSR”), as well as international quality system standards, such as ISO 13485:2003, as necessary. 10.2 PACIFIC PHARMA is responsible for ensuring that it conducts any quality related activities in reasonable compliance with the requirements of the Territory Regulatory Authority.
Appears in 1 contract
Sources: Distribution Agreement (Viveon Health Acquisition Corp.)
Manufacturing Practices. 10.1 SUNEVA is responsible for ensuring that all Products are designed and manufactured in material compliance with cGMP, including FDA’s Good Manufacturing Practices, which are now codified in the Quality System Regulation (“QSR”), as well as international quality system standards, such as ISO 13485:200313485:2003 (or later version(s) thereof), as necessary.
10.2 PACIFIC PHARMA is responsible for ensuring that it conducts any quality related activities in reasonable compliance with the requirements of the Territory Regulatory Authority.
Appears in 1 contract
Sources: Distribution Agreement (Viveon Health Acquisition Corp.)