Many companies involved with cGMP manufacture outsource calibration of critical equipment used in cGMP production, but many also outsource equipment maintenance. This makes sense from a resource point of view–often there are not enough people do perform these tasks within the organization, and sometimes equipment is specialized, and therefore better maintained by the company that made or sold it. But from a compliance/regulatory perspective the sponsor of the IND or regulatory authority license is still responsible for these tasks, even though they are outsourced (see 21CFR 211.67 for the US FDA regulation). Sometimes, unfortunately, once this task is outsourced it is often put on the back burner–“oh so and so is doing that for us, so its OK,” and sometimes forgotten altogether.
It is usually the job of QA to have oversight of maintenance and calibration and their associated schedules, although this too is often handed off to another company. In my auditing role, where I assist companies getting ready for an FDA, EU, or other regulatory authority inspection, I have seen QA oversight to sometimes be lacking in this area. For example, I have seen equipment continued to be used when it clearly needed maintenance; and in this case, the maintenance schedule needed to be adjusted, but was not. I have also seen out of calibration equipment being used for GMP production, which of course, would lead to an unnecessary deviation if it was calibrated on time. In the rare case, I have seen critical equipment that had no maintenance at all, and it was simply fixed if it broke down, a clear violation of the cGMPs that state that critical equipment must be maintained.
So, just a reminder that all cGMP equipment, and for certain, critical cGMP equipment needs both calibration and maintenance, and though the schedule for these activities is often set by the manufacturer, more frequent maintenance or calibration is sometimes required where the equipment is very important or used quite a bit more than usual. QA should therefore periodically review both maintenance and calibration schedules, to ensure the schedules fit with current use, demand, and good functioning of the cGMP equipment.