DUE DILIGENCE CHECK LIST FOR COMPOUNDING PHARMACY QUALITY AND STERILITY

Are you committed to compliance with the new USP 797-guidelines for sterile compounding?
Where are you in the implementation?

Do you filter (0.2 micron) in a Class 100 laminar airflow hood contained in a Class 1000 cleanroom, or autoclave where appropriate, to achieve sterility?

Do you obtain independent, semi-annual certifications of your cleanrooms and laminar airflow hoods?

Do you perform sterility testing on every product batch?

Do you perform post-filtration filter-integrity testing?

Do you conduct monthly independent lab tests of air and surface samples in your cleanrooms?

Do you have a dedicated Quality Assurance Department?

Is the air quality in your general compounding lab engineered for HEPA filtration to reduce particulates?

Are your pharmacists and technical staff dedicated exclusively to compounding?

Are you active members of the American College of Apothecaries the American College of Veterinary Medicine and the International Academy of Compounding Pharmacists?

Is your staff trained and validated in proper gowning and aseptic techniques, cleanroom regulations and USP Guidelines?

Do you purchase pharmaceutical-grade chemicals (USP, NF equivalent) from FDA-registered suppliers?

Do you perform pH testing on injections, ophthalmic preparations and other compounds?

Do you verify the potency of finished compounds through weight, volume and yield checks?

Do you perform HPLC validation on selected formulations?

Is every step of the compounding process from prescribing to compounding and labeling through dispensing reviewed and authorized by a licensed pharmacist?

Do you maintain both master formulas and lot-specific worksheets for all compounds? (Do they include the manufacturer and lot number of each ingredient and quality-control test result?)

Can you trace a prescription back to the original formula log sheet and the source of ingredients?

Does the pharmacy have adequate liability insurance?

Do you test your staff on a regular basis to ensure competency?

Are your sterile compounds certified by an independent agency such as American College of Apothecaries?