Common use of Validation/Qualification Clause in Contracts

Validation/Qualification. 10.01 Maintain a written master validation/qualification plan for the facilities, equipment/instruments, manufacturing process, cleaning procedures, analytical procedures, in process control tests and X computerized systems approved by the quality unit. 10.02 Prepare and maintain validation/qualification documentation approved by the quality unit, including protocols, reports and associated documentation. Provide such documents to Manufacturer 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 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. X 10.05 Validate/qualify methods and procedures for cleaning of equipment with acceptance criteria for residues defined and justified. X 10.06 Develop and execute a plan for process and method validation/qualification including definition of roles and responsibilities between Customer and Manufacturer for performing technology transfers, if applicable. X X 10.07 Where method validation is performed by Manufacturer: • Manufacturer shall write method validation protocol, X • Customer and Manufacturer shall review and approve method validation protocol. Customer should make a good faith effort to provide feedback within 5 business days or notify Manufacturer. X X • Manufacturer shall execute method validation protocol, X • Manufacturer shall write method validation report, and X • Customer and Manufacturer shall review and approve method validation report. Customer should make a good faith effort to provide feedback within 5 business days or notify Manufacturer. X X 10.08 For process validation: • Write process validation protocol, X • Review and approve process validation protocol. Make a good faith effort to provide feedback within 5 business days or notify The author. X X • Execute process validation protocol, X • Write process validation report, and X • Review and approve process validation report. Make a good faith effort to provide feedback within 5 business days or notify the author. X X 10.09 Validate/qualify all manufacturing processes, Product formulation, mixing operations and hold times for the formulation process. X 10.10 Qualify time limitations for each phase of production. X 10.11 Evaluate protocol deviations encountered during X validation/qualification to determine impact on validation/qualification studies, including need to conduct repeat studies.

Validation/Qualification. 10.01 Maintain a written master validation/qualification plan for the facilities, equipment/instruments, manufacturing process, cleaning procedures, analytical procedures, in process control tests and X § Responsibilities Customer Manufacturer computerized systems approved by the quality unit. 10.02 Prepare and maintain validation/qualification documentation approved by the quality unit, including protocols, reports and associated documentation. Provide such documents to Manufacturer upon request. XX Section 10.03 through 10.11 are only applicable to new or replaced equipment through the validity of the Product Addendum. 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 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. X 10.05 Validate/qualify methods and procedures for cleaning of equipment with acceptance criteria for residues defined and justified. X 10.06 Develop and execute a plan for process and method validation/qualification including definition of roles and responsibilities between Customer and Manufacturer for performing technology transfers, if applicable. X X X 10.07 Where method validation is performed by Manufacturer: • Manufacturer shall write method validation protocol, X • Customer and Manufacturer shall review and approve method validation protocol. Customer should make a good faith effort to provide feedback within 5 business days or notify Manufacturer. X X • Manufacturer shall execute method validation protocol, X • Manufacturer shall write method validation report, and X • Customer and Manufacturer shall review and approve method validation report. Customer should make a good faith effort to provide feedback within 5 business days or notify Manufacturer. X X 10.08 For process validation: • Write process validation protocol, X • Review and approve process validation protocol. Make a good faith effort to provide feedback within 5 business days or notify The author. X X • Execute process validation protocol, X • Write process validation report, and X • Review and approve process validation report. Make a good faith effort to provide feedback within 5 business days or notify the author. X X 10.09 Validate/qualify all manufacturing processes, Product formulation, mixing operations and hold times for the formulation process. X 10.10 Qualify time limitations for each phase of production. X 10.11 Evaluate protocol deviations encountered during X validation/qualification to determine impact on validation/qualification studies, including need to conduct repeat studies.