The paper spine of the operation: recipes, batch records, investigations. Most of it lives in your dispensing system or a binder, not in any oversight tool.
“Show me the Master Formulation Record for a preparation you compound regularly.”
A good answer: A written record per preparation: ingredients with amounts and sources, equipment, step-by-step method, beyond-use date and its basis, container closure, and labeling.
It is the recipe of record. Without it, two technicians can make the same preparation differently and nobody can tell.
“Show me the Compounding Record for the last batch you made.”
A good answer: A per-batch record naming who compounded, the lots of every component used, the yield, the checks performed, and who verified.
This is the link between a finished preparation and the components you can prove. Its absence breaks traceability in both directions.
“What beyond-use date do you assign this preparation, and on what basis?”
A good answer: The BUD, the specific USP category or stability data it rests on, and the SOP that fixes the method.
BUD errors are among the most frequently cited findings, usually from inconsistent method rather than bad intent.
“Show me a finished label and the SOP that governs it.”
A good answer: Content required by your state, auxiliary and hazard labelling, and the review step that catches errors before dispensing.
“Show me your last deviation, its investigation, and the corrective action you took.”
A good answer: A written investigation with a root cause, a corrective action, a due date, and evidence it was completed and effective.
A serious inspector digs here, because it shows whether your quality system is a habit or a binder.
“Show me the complaint and adverse-event log and one closed investigation.”
A good answer: A log with dates, the investigation, the conclusion, and the corrective action, closed on a stated timeframe.
“Show me current licenses for every pharmacist and technician working today.”
A good answer: Each individual license with its expiry, current, and a process that catches a lapse before it happens.
Facility registrations and individual licensure are different files; inspections ask for both.
Domain 2 of 5