Compound Preferred Confidence in Quality
As we provide high-quality and compliant pharmaceutical products to the medical community, regulating practices and procedures is of utmost importance at Compound Preferred. Moreover, our vision is to be recognized as the most trusted, innovative, and dependable outsourcing facility in the industry. We are dedicated to continuously meeting customers’ unique needs by providing easy access to safe and affordable quality products.
Samantha Kunz is Compound Preferred’s Brand and Communications Manager. She interviewed Casey Hunter, Quality Assurance and Regulatory Affairs Manager, to find out more about the procedures set in place to create “quality assurance.”
Samantha: Do we participate in Medwatch?
Samantha: How do we participate?
Casey: Our procedures require us to investigate any customer complaint of an adverse event. If we receive a complaint, it is initially evaluated. We determine if it is a “serious adverse event” as defined by the FDA. If the evaluation concludes that it is a serious adverse event, and neither the practitioner nor customer has initiated the Medwatch Form 3500A, then we then will initiate and submit the form to the FDA.
Samantha: Are our product’s BUD (before use date) supported by data?
Casey: We have a procedure that clearly defines how to determine the BUD. The initial BUD is based on research performed by the Head Pharmacist, Pharmacist in Charge, or Operations Manager. He will reference previous studies and research that have been performed for ingredients used to make the finished product to determine an initial BUD. We then send the product to a third-party laboratory for potency testing at time zero (right when we make it). Then at the BUD, we do a confirmatory potency test on the same lot to verify the BUD. A stability indicating potency test can be performed by the FDA registered contract laboratory as confirmation.
Samantha: What’s the difference between our quality and the quality of another company?
Casey: There is guidance set for outsourcing facilities and compounding pharmaceutical products called CSPs (compounded sterile preparation), which we follow. There are multiple references throughout the guidance to 21 CFR 210 and 21 CFR 211, which are followed by pharmaceutical manufacturers.
Before Compound Preferred, my experience was with a big pharma company, one of the world’s largest generic pharmaceutical manufacturers, and then at another company that produced over-the-counter products. Those both deal heavily in Active Pharmaceutical Ingredients (APIs) and excipients to make products. My approach here with Compound Preferred has aligned with what I learned in previous experience, which is quality by design. Initially making sure that your quality is in place so that your product meets those requirements. With big pharma and 503B’s, an expectation already exists from the FDA that regulations are being met, unlike 503A’s who are not regulated to meet those requirements. Therefore, Compound Preferred’s quality differs to that of 503A’s because our quality measures are held to a higher standard.
Samantha: What testing do we do specifically?
Casey: We are required to perform identity and strength testing for any lot that is 60 units or more or any lot where a sixtieth unit is produced from the last tested lot. Potency is a test performed by an FDA registered contract laboratory.
We do product inspections per internal Standard Operating Procedures (SOPs) and Master Batch Record (MBR) requirements.
We conduct pH testing and endotoxin testing internally, which are both required. Potency and sterility testing are performed by an FDA registered contract laboratory when required.
Samantha: What does that say about our quality and process system?
Casey: It means our procedures, processes, and quality protocol are correct. We have never had a Medwatch 3500A form initiated and never had a serious adverse event reported from a customer.
Samantha: What does our tagline, “Strength in specialty and confidence in quality,” really mean?
Casey: It means that we are confident in our quality because we have these procedures in place, and they are proving effective. With that confidence comes the ability to focus on specialty and custom solutions for our customers.
Samantha Kunz is a recent BYU-Idaho graduate, majoring in Communications. Her drive and passion for making a difference in the lives of people she works with meets and serves have been an essential advantage to The PharmEase Group. She enjoys continuing her education and enjoying a good movie with her family.
Casey Hunter has over ten years of experience in Pharmaceutical/Medical Device Quality Control/Quality Assurance. He finds satisfaction in ensuring processes are compliant and safe. In his free time, Casey loves snowmobiling.