Looking for examples of GMP and KPI templates
Can anyone give me any ideas of any GMP and KPI templates?
GMP inspection template, or a full GMP program/policy?
just a GMP inspection template
We have a dual layer approach to this - one includes a checklist, one doesn't.
Monthly, the full facility is inspected. One facility is divided into 12 areas and the other is divided into 14. Supervisors (maintenance, production, sanitation, shipping, receiving) are assigned to teams and are responsible for a different area each month. They have been trained (internally by management, and externally by AIB) on how to conduct the inspections and have a blank inspection form that they fill out. I am currently developing a full blown, interactive training program for them to go through - but that isn't set to be done until the end of the year.
The second inspection we do is quarterly and involves members of one facility traveling to the other facility to do an inspection. This inspection encompasses the full facility and takes several days. A checklist is used to cover everything that they need to check on the interior and exterior of the building, as well as a record review. It includes area's of the facility (roof, silo pads, packaging, wash room, boiler room, etc), things that need to be opened (yeast tank, silo magnet, water magnet, etc), and specific records to look at (metal detector logs, pest logs, gbpc list verification, chemical list, etc.). The checklist is 4+ pages. In addition to that, they also document any findings on the same form that the supervisor uses monthly.
CG, GMP inspections are kind of like fingerprints for most facilities. I have attached a 8+ year old monthly GMP inspection I made for a facility that is no longer in operation. I've learned quite a bit in 8 years, so this might be pretty green. It should give you a general idea though.