QUESTIONS FOR YOUR COMPOUNDING PHARMACY (QUALITY ASSURANCE)
Do you have a long established reputation as an expert in the field of compounding and well respected by your peers?
Are you in compliance with USP-797 guidelines for sterile compounding?
Have you or any of your staff ever been under suspicion of, or had charges brought against you, for questionable practices?
Do you filter (0.2 micron) in a ISO Class 5 Laminar airflow hood contained in a ISO Class 6 cleanroom, or autoclave where appropriate, to achieve sterility?
Do you perform sterility testing on every product batch?
Do you perform post-filtration filter-integrity testing?
Is the air quality in your general compounding lab engineered for HEPA filtration to reduce particulates?
Are you recognized as a fellow in any professional associations such as the American College of Apothecaries or the International Academy of Compounding Pharmacists?
Is your staff trained and validated in proper aseptic technique, cleanroom regulations and USP guidelines?
Do you purchase only 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 reviewed and authorized by a licensed trained compounding pharmacist?
Do you maintain master formulas and lot-specific worksheets for all compounds?
Can you trace prescriptions back to the original formula log sheet and source of ingredients?
- referenced from Healthway Compounding Pharmacy's Website
