Common use of Validation/Qualification Clause in Contracts

Validation/Qualification. 10.1 Maintain 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. --- --- × 10.2 Prepare and maintain validation/qualification documentation approved by the quality unit, including protocols, reports and associated documentation. Provide such documents during audits. --- --- × 10.3 Sections 10.3 through 10.10 are only applicable to new or replaced equipment. 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)). --- --- × 10.4 Computer systems and associated software used in Good Manufacturing Practices related activities associated with the Product should be validated/qualified. Procedures must be in place to assure the integrity, archiving, retrieval and destruction of the electronic data that comply with applicable regulations. --- --- × 10.5 Validate/qualify methods and procedures for cleaning of equipment with acceptance criteria for residues defined and justified. --- --- × 10.6 Develop and execute a plan for process and method validation/qualification. --- --- × 10.7 Where method validation is performed by Manufacturer: Manufacturer shall write method validation protocol, --- --- × Manufacturer shall review and approve method validation protocol --- --- × Manufacturer shall execute method validation protocol, --- --- × Manufacturer shall write method validation report, and --- --- × Manufacturer shall review and approve method validation report. --- --- × 10.8 For process validation: Write process validation protocol, --- --- × Review and approve process validation protocol. --- --- × Execute process validation protocol, --- --- × Write process validation report, and --- --- × Review and approve process validation report. --- --- × 10.9 Validate/qualify all manufacturing processes, Product formulation, mixing operations and hold times for the formulation process according to Nordmark SOP. --- --- × 10.10 Evaluate protocol deviations encountered during validation/qualification to determine impact on validation/qualification studies, including need to conduct repeat studies. --- --- × 10.11 Evaluate validated/qualified systems and processes periodically to verify they are still operating in a valid manner. --- --- ×

Validation/Qualification. 10.1 Maintain 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. --- --- × 10.2 Prepare and maintain validation/qualification documentation approved by the quality unit, including protocols, reports and associated documentation. Provide such documents during audits. --- --- × 10.3 Sections 10.3 through 10.10 are only applicable to new or replaced equipment. 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)). --- --- × 10.4 Computer systems and associated software used in Good Manufacturing Practices related activities associated with the Product should be validated/qualified. Procedures must be in place to assure the integrity, archiving, retrieval and destruction of the electronic data that comply with applicable regulations. --- --- × 10.5 Validate/qualify methods and procedures for cleaning of equipment with acceptance criteria for residues defined and justified. --- --- × 10.6 Develop and execute a plan for process and method validation/qualification. --- --- × 10.7 Where method validation is performed by Manufacturer: • Manufacturer shall write method validation protocol, --- --- × • Manufacturer shall review and approve method validation protocol --- --- × • Manufacturer shall execute method validation protocol, --- --- × • Manufacturer shall write method validation report, and --- --- × • Manufacturer shall review and approve method validation report. --- --- × --- --- × --- --- × --- --- × --- --- × 10.8 For process validation: • Write process validation protocol, --- --- × • Review and approve process validation protocol. --- --- × • Execute process validation protocol, --- --- × • Write process validation report, and --- --- × • Review and approve process validation report. --- --- × --- --- × --- --- × --- --- × --- --- × 10.9 Validate/qualify all manufacturing processes, Product formulation, mixing operations and hold times for the formulation process according to Nordmark SOP. --- --- × 10.10 Evaluate protocol deviations encountered during validation/qualification to determine impact on validation/qualification studies, including need to conduct repeat studies. --- --- × 10.11 Evaluate validated/qualified systems and processes periodically to verify they are still operating in a valid manner. --- --- ×