Validation/Qualification. 10.01 Have a written master validation/qualification plan for the facilities, equipment/instruments, manufacturing process, cleaning procedures, analytical procedures, in process control tests and computerized systems approved by the quality unit. X 10.02 Prepare and maintain validation/qualification documentation approved by the quality unit, including protocols, reports and associated documentation. Provide such documents to Wyeth upon request. X 10.03 Validate/qualify as necessary all critical systems, utilities and equipment/instruments used for the manufacture and control of Product (Installation Qualification (IQ), Operational Qualification (OQ), and/or Performance Qualification (PQ)). X 10.04 Validate/qualify computer systems and associated software used in Good Manufacturing Practices related activities associated with the Product. Procedures must be in place to assure the integrity, archival, retrieval and destruction of the electronic data that comply with applicable regulations. X
Appears in 2 contracts
Sources: Supply Agreement (Amphastar Pharmaceuticals, Inc.), Supply Agreement (Amphastar Pharmaceuticals, Inc.)