01Purpose, scope and ownership
- ✓A specific purpose, applicable compounding level, locations, preparations and exclusions
- ✓Named pharmacy roles with duties that can be assigned and verified in practice
- ✓Required training, competency and authorization before performing the procedure
- ✓Definitions and controlled references needed to interpret the procedure
Procedure design
- ✓A clear sequence based on the pharmacy's actual room, equipment, materials and workflow
- ✓Decision points, independent checks, acceptance criteria and required records
- ✓Safety controls, PPE, cleaning, spill, waste and deviation instructions where applicable
- ✓Links to forms and logs without duplicating information that changes frequently
Controlled lifecycle
- ✓Document number, owner, version, effective date, review date and approval signatures
- ✓Read-and-understood acknowledgement plus training and competency evidence
- ✓Controlled distribution at points of use and protection from unauthorized changes
- ✓Change control, impact assessment, superseded-copy removal and archive retention