Santa and GMPs

Well, the holiday season is upon us and children of all ages are watching out for Santa’s sleigh and his famous reindeer. But what would Santa’s sleigh look like if it was GMP you ask? My guess is that it would be both a process and equipment and would need some GMP controls of course. Considering the sleigh, let’s say its equipment and runs on fusion energy, perhaps water or deuterium. Being both equipment and having an animal component, it would likely be classified as complicated equipment requiring validation, post risk assessment. So, we’ll give it at least an IQ and OQ, and maybe even a PQ if QA requires it. The IQ could ensure that a user’s manual is available, that certain basic requirements of installation such as power on, auto leveling and perhaps an SOP are all in place. The OQ would consider that the design ranges are met, say running with 1 reindeer and also all nine reindeer, and at design speeds, design loads, as well as operation of all controls work sufficiently. Then if the PQ is needed, we could load up the sleigh with presents and off we go to deliver enough to have confidence that the sleigh will work with Santa and his reindeer as intended.
Which brings me to the point of this blog—one must have validation standards, either in an SOP or policy, which lays down what is validated, the validation process and extent, and the standards for IQ, OQ, PQ, and Process Validation. Every organization using GMP needs this written standard, or to point to a written standard such as ISPE.
Merry Christmas and Happy Holidays from JGBC to you, and if you see Santa, don’t ask him about validation, just give the reindeer some treats and Santa some cookies (but do ask if he uses deuterium or water for the sleigh, I’m so curious!).