1. Manufacturing integrity
– Do they comply with the requirements of USP 797?
– Is their clean room monitored and validated?
- Has Ribo-typing been performed?
- Has the equipment been validated to perform within its specifications?
- Can the clean room conditions be matched to time of drug compounding?
– Manufacturing procedures:
- Are there standard operating procedures in place?
- Can they be produced for verification?
- Can they electronically validate all weights of powders in each formula?
- Can photographic evidence be produced for all liquid measurements in each formula?
2. Third-party validation
– Do they serve national accounts (AmSurg, etc.) or are they vendors for GPOs?
– What other companies or agencies have inspected them (pharma, independent cGMP audits, etc.)?
– Can they provide references from other customers?
3. Leadership/customer service
– What are the resumes of top management? Are pharmacists leading the company?
– Who is available for technical questions and how fast are they answered?
– What are the qualifications of the staff and technicians at the facility?