Process Validation. Bachem will ensure that the manufacturing process used is fully validated, approved by Bachem’s Quality Assurance and Regulatory Affairs groups and meets Competent Authorities requirements. Bachem will document the process validation, and at Xeris’ request, disclose such documentation to Xeris for on-site review at Bachem.
Appears in 3 contracts
Sources: Quality Assurance Agreement, Quality Assurance Agreement (Xeris Pharmaceuticals Inc), Quality Assurance Agreement (Xeris Pharmaceuticals Inc)