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In reviewing the current FDA GMP manual, I see no specific requirement that a DMR, as an item, be revision controlled. Clearly, the individual records comprising the DMR need revision control, but I was somewhat surprised to see that the DMR ITSELF does not, per the requirement, need to be revision controlled. I find this interesting as most organizations (except my current one) do revision-control the DMR. Consequently, the DMR always needs updating when one of it's components is revised. Again, given no requirement to do so, why do organizations typically create this additional burden for themselves? Conversely, if someone can identify a procedural requirement to control the DMR as an item, I'd appreciate their input!
