PRODUCTION SYSTEMS. Manufacture of clinical batches of Product will be done at BIP’s pharmaceutical manufacturing facility and will occur on a campaign basis. BIP will use procedures for manufacturing and control of Product set forth in the Master Batch Records according to Process Descriptions approved by CLIENT. BIP’s Quality Assurance organisation will review the completed documentation and confirm that all activities were carried out in accordance with Process instructions and cGMPs.
Appears in 2 contracts
Sources: Master Process Development and Clinical Supply Agreement, Master Process Development and Clinical Supply Agreement (Prothena Corp PLC)