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Hi everyone,
I am in the process of preparing an Original PMA application for a stent device. Having reviewed the process validation requirements within the Manufacturing Information section of "Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff" (extracted below), I understand that the VMP and individual validation protocols are required for inclusion in the VMP.
My question relates to the level of detail required for the validation of software used in the production process. Would you consider it sufficient to indicate the software validation requirements on the VMP for each production process? Or would FDA expect to see the individual protocols?
Many thanks
Process Validation, 820.75
7. You should provide a copy of your process validation master plan, or a description of which manufacturing processes you will validate, for the device under review. Provide a list of processes for the device under review that you do not plan to validate but will verify by inspection and test.
- Your process validation master plan or your description should also include any validations of software used as part of the production or quality system. (See 820.70(i))
Process Validation, 820.75(a)
8. You should provide a copy of the validation procedure(s) or individual validation plan(s) for each process that will be validated for the device under review. When available, you should provide a copy of any completed validation reports.
- Your validation procedure(s) or plan(s) should contain or refer to objective and measurable acceptance criteria.
- Your validation procedure(s) or plan(s) should describe how appropriate statistical methods for data collection and analysis are used.
- Your validation procedure(s) or plan(s) should define the criteria for re-validation.
Your validation plan and procedures(s) should be in place at the time of submission of the manufacturing information. Process validations do not have to be completed at the time of submission. However, process validations must be completed prior to the preapproval inspection and prior to distribution of any finished devices. [820.75(a)].