At APS Pharmacy we take our responsibility to our patients very seriously. Quality Assurance is an important consideration in running our pharmacy. We meticulously follow USP Chapter <797> (Pharmaceutical Compounding-Sterile) guidelines, as well as carefully monitoring the special guidelines for each individual state that we are licensed in. As Chapter <797> is undergoing revision, we have also made preemptive changes regarding a new guideline chapter <800> (Hazardous Drugs- Handling in Health Care Setting), that will become enforceable very soon. We have built a new negative pressure clean-room anticipatorily, in addition to the positive pressure clean room already in place.
Furthermore, more frequent Environmental testing of the clean rooms has been implemented. Our quality assurance department has designed a custom monitoring program. We use our own equipment to test the air of our clean rooms. A calibrated SAS DUO 360 air sampler is used to monitor viable air. The samples are taken by our own qualified staff and incubated in two types of media in our incubators according the manufacturer’s instructions. The goal is to be able to identify bacteria as well as fungi, mold, or pathogens and take corrective actions immediately if they are detected.
We use NIST calibrated thermometers to monitor the temperature of our incubators daily. Results of the viable environmental monitoring are reviewed carefully by our Quality Assurance Pharmacist. This entire process allows APS to have complete control of the procedures taking place within the clean rooms rather than depending on an outsourced company or vendor. Taking personal responsibility for the environment within the clean rooms is one of the things that differentiate APS from other pharmacies.
Going over and above the regular guidelines is a practice we also frequently implement. We practice more frequent endotoxin testing than what is required by USP <797>. We have an in-house endotoxin tester which gives our experts quantitative results for endotoxins within 15 minutes.
Finally, we have a dedicated Quality Assurance Pharmacist on staff with over 20 years of experience, responsible for creating and maintaining Standard Operating Procedures (SOP’s). The QA Pharmacist is dedicated to overseeing and enforcing all the procedures related to quality control. As you can see, Quality Assurance and the safety of our patients is our number one priority at APS Pharmacy. We stand behind the quality and purity of our products, and you can too!
Written by the APS Quality Assurance Department
