C.02.006 Qualification

I like puzzles. Like this one : Why should a supervisor need to be a university graduate to supervise in the manufacturing area but NOT in the packaging area? The Canadian regs are pretty explicit about this. Is a danger to contaminate the product that different from one area to another? Or, more importantly, does the patient affected by a contaminated product see a difference between a product contaminated by a metal particle from the tablet press and one whose integrity was affected by a deficient storage system? What about the young lady taking a contraceptive sample, handed down by her physician after staying in the trunk of a sales rep’s car 3 days at 42? or the pre-school kid finding a nitro granule in his daily vitamin, will they ask enquire about the education level of the person responsible to supervise the operations?

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