Process and Analytical Method Validation. Formosa will generate process and method validation protocols in accordance with all applicable cGMP regulations, guidances and ICH guidances. [***]. Formosa is responsible for the execution of the validation activities and generation of final reports. NGX will review and approve the final reports. Any problems encountered during the execution of the protocol must be documented by Formosa and notifications must be sent to NGX within [***].
Appears in 2 contracts
Sources: Manufacturing Agreement, Manufacturing and Supply Agreement (NeurogesX Inc)