Successful process validation is intended to prevent product recalls, as there is evidence that the manufacturing process can be replicated while meeting all the requirements. For an original equipment manufacturer, increasing validation success requires the contract manufacturer (CM) and the OEM to work on the plan. Not only does validation satisfy regulatory requirements, but it also saves money and time in the long run. It reduces lengthy device testing and decreases the need for rework. An example of mitigating future issues is when the CM validates multiple pieces of equipment of the same kind, in case of equipment failure, along with a preventative maintenance plan. What else is a contract manufacturer supposed to provide for process validation? What risks and benefits are associated with working with a CM?
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Posted : 08/11/2025 11:29 pm