011. Define the pharmacy's scope
- ✓Active formula inventory, dosage forms, compounding levels, frequency and batch sizes
- ✓Personnel, roles, facilities, equipment, suppliers and external service providers
- ✓Upcoming assessments, renovations, ownership changes or service expansion
2. Inventory the evidence
- ✓MFRs, formula risk assessments, compounding records, labels and BUD evidence
- ✓SOPs, training, competency, cleaning, maintenance, calibration and environmental records
- ✓SDS and CoA files, receiving records, deviations, complaints, recalls, CAPA and audits
3. Test control and linkage
- ✓Can staff identify the current approved version at the point of use?
- ✓Does each formula link to its risk assessment, references, SOPs and required records?
- ✓Are review dates, approvals, revisions and missing records visible and assigned?
4. Prioritize and close gaps
- ✓Rank immediate safety and authorization gaps before formatting improvements
- ✓Assign an owner, evidence requirement, action, due date and verification method
- ✓Recheck completed actions and retain evidence of closure and effectiveness