For sure your existing Risk Management Report should be updated to reflect the specification, process and inspection controls you will have to ensure the labels are accurately and legibly printed. You need to make sure that these risk reduction measures are strong. I recommend having requirements for 100% label inspection by the person printing the labels, and 100% inspection by an independent person.
With regard to the need for process validation, the label printing operation can be rendered "non-special" since the process output is fully verifiable through subsequent inspection. You will at least need 100% inspection for this, but my experience has been that adding a second person inspection is more effective. Didn't someone say once that 100% inspection is only 80% effective (?).
If you find it uneconomical to fully inspect the process output then you will want to execute a process validation study. However, due the importance of labeling and the number of removals/recalls that stem from labeling errors (number 1 cause of recalls still?) I would still apply plenty of inspections.
If your label printing system has software (automated process), here is another consideration.
FDA 21 CFR 820 requires the following:
820.70 Production and process controls.
(i) Automated processes. When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented.
ISO 13485 (7.5.2.1) requires the following:
The organization shall establish documented procedures for the validation of the application of computer software (and changes to such software and/or its application) for production and service provision that affect the ability of the product to conform to specified requirements. Such software applications shall be validated prior to initial use.
My recommendation is cover the use of the software in your "Master Process Validation Plan/Report" (MPVPR) by stating that the automated labeling system process output is routinely fully verified against requirements. In this sense, the routine full verifications serve to validate the process each and every time you operate the process. I have successfully defended this for years. The MPVPR refers to the work instructions which require the 200% inspections for each label, and therefore serve as the "protocol" required by 820.70(i).
Sam
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