Quality Checklist

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Quality Checklist 2016-11-14T20:42:49+00:00

Because of the strict USP guidelines for compounding, it’s more important than ever for prescribers to choose a compounding pharmacy they can trust. When you are choosing a compounding pharmacy to work with you, be sure to ask questions like those listed below. We are known for providing its clients with the safest products on the market.

Is every step of the compounding process from prescribing to compounding and labeling through dispensing reviewed and verified by a licensed pharmacist? Yes
Do you verify the potency of finished compounds through the weight, volume and yield checks? Weights on formula sheets, volume on formula sheets, yield on packaging formula sheets
Do you perform pH testing on injections and other compounds? Yes – results are documented on formula sheets
Do you perform 3rd party HPLC verification on certain formulations? Yes, on every injection made in batches over 24, and monthly on random pulls of creams and capsules
Are you committed to compliance with the USP guidelines for sterile compounding? Have you completed a gap analysis? Yes
Based on your assessment of , are you compounding preparations at the lowest risk to your doctors and patients? Yes
If you are compounding sterile preparations, do you conduct weekly and monthly independent lab tests of air and surface samples in your clean-room and other controlled environments? Weekly in-house surface tests,  air tests conducted monthly in-house. These are validated bi-annually through testing from third-party labs.
Is the air quality in your general compounding lab engineered for HEPA filtration to reduce particulates? All chemicals are manipulated in an area filtered directly by a HEPA system
Do you obtain independent, routine certifications of your clean rooms and laminar airflow hoods? Twice each year
Do you perform daily monitoring and documentation of your clean-room temperature? Yes
Is your staff properly trained and evaluated in aseptic manipulation skills, gowning technique and clean-room use? Yes, and they are tested and re-certified numerous times throughout the year. Follow-up tests are unannounced.
Do you have systems in place for handling complaints and investigating sterility adverse events? Yes
In the event of a sterility failure, complaint or adverse event, do you have a procedure in place for determining and conducting a recall, if necessary? Yes
Do you filter (0.2 micron) in a Class 100 (ISO 5) laminar airflow hood contained in a Class 1000 (ISO 6) clean room, or autoclave where appropriate, to achieve sterility? Yes
Do you perform sterility testing on every preparation batch? On those over 24 in quantity, samples are sent to an independent lab and every intrathecal batch is tested with in-house media testing. We use multiple labs as a cross-check method.
Do you perform sterility testing according to USP Sterility Tests and USP Bacterial Endotoxin (Pyrogen) Test? Yes
Do you purchase USP pharmaceutical-grade chemicals? Yes
Do you obtain Certificate of Analyses for all formula ingredients? Yes
Do you maintain both master formulas and lot-specific worksheets for all compounds? Yes
Can you immediately trace a prescription back to the original formula log sheet and the source of ingredients? Yes
Are your pharmacists, technical and customer-service staff dedicated exclusively to compounding? Yes – WE do NOT stock or fill any orders for commercially available products without assurance that there is a therapeutic preference or a supply shortage for a compounder preparation.
Does the pharmacy have adequate liability insurance? Yes