Validation team member

Note Qualification must be in accordance with the job requirement in combination with experience. 

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It is the responsibility of validation team members to foffow the procedures. The quality assurance (QA) manager is responsibfe for SOP compliance. 

Testing is to be conducted by designated test personnel. Each test result must be recorded (normally handwritten and initialed) by the person who conducted the test and similarly verified by a second person designated to check that the procedure has been carried out and the results are complete. Test results must be formally evaluated against the predefined acceptance criteria and the conclusions (e.g., unconditional pass or fail) recorded complete with an explanatory comment by a designated validation team member (normally the second test person). In instances in which a conditional pass conclusion is justified, this must be formally reviewed and rigorous controls imposed on the pass conditions. Approval and sign-off of the completed test records is normally the responsibility of the quality department representative on the validation team. 

This master plan is used, managed, and enforced throughout the life of a process to help ensure quality. The document defines the validation approach, specifies the responsibilities of each of the validation team members, and is an important part of the overall validation effort at the beginning of a project. 

A validation team member from the Production department is responsible to participate in performing the validation steps during manufacturing processes and equipment qualification. This department should prepare the necessary SOPs for the new process or equipment and assist in the collection of validation data. 

A validation team member from the Maintenance department participates in performing the validation defining the necessary equipment specifications, limitations, capacity, calibration, and maintenance requirements and providing the necessary training on the proper operation and maintenance of the equipment. The Maintenance department should be responsible for providing the necessary utilities and equipment accessories. 

A validation team member from Product Development Laboratories is responsible for defining the process (new product or process) to be validated and for providing technical assistance to the validation team by defining specifications, limits, and manufacturing methods. 

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