I am in process of performing impact assessments on packaging equipment (OTC enviroment). I am having a problem with developing the supporting rationale for a no impact system / equipment. Can anyone lead me in the direct of what the FDA is wanting / expecting for this type of decision?
Can anyone give an example?
Thanks for any help and thank you for your time.
Impact on quality. Maybe if you had something to cut some packing material to a specific length but then had additional equipment to verify the length was correct (and rejected any that wasn’t), the cutting equipment may be no impact but the inspection equipment would be. Or maybe if you had some equipment to do some counting for business reasons but controls were in place to ensure even if the counts were incorrect, there would be no impact. Just wingin’ it here.