Common use of Validation/Qualification Clause in Contracts

Validation/Qualification. 7.01 Determine according to Product lifecycle and guidance documents when process validation is required. 🞏 🞏 🗹 7.02 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 as appropriate. These to be approved by the quality unit. Client may provide validated methods, process validation, and in-process controls. Written copies to be provided to Supplier. 🞏 🗹 🗹 7.03 Responsible for developing, preparing and maintaining validation documentation approved by the quality unit, including protocols, reports and associated documentation. 🞏 🞏 🗹 7.04 Qualify as necessary all critical systems and equipment used for the manufacture and control of Product (Installation Qualification (IQ), Operational Qualification (OQ), and/or Performance Qualification (PQ)). 🞏 🞏 🗹 7.05 Allow viewing of the validation documentation for the Product during an onsite audit. 🞏 🞏 🗹

Validation/Qualification. 7.01 Determine according to Product lifecycle and guidance documents when process validation is required. 🞏 🞏   🗹 7.02 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 as appropriate. These to be approved by the quality unit. Client may provide validated methods, process validation, and in-process controls. Written copies to be provided to Supplier. 🞏   🗹 🗹 7.03 Responsible for developing, preparing and maintaining validation documentation approved by the quality unit, including protocols, reports and associated documentation.   🞏 🞏 🗹 7.04 Qualify as necessary all critical systems and equipment used for the manufacture and control of Product (Installation Qualification (IQ), Operational Qualification (OQ), and/or Performance Qualification (PQ  )). 🞏 🞏 🗹 7.05 Allow viewing of the validation documentation for the Product during an onsite   audit. 🞏 🞏 🗹