Knowledge Center

Category: Quality Assurance

Implantable Pump Concerns

I have become aware of a potential problem regarding programming of implantable infusion pumps that I wish to share. As you are aware, Hartley provides medications for a large number of implantable practices throughout the United States. Recently, I became aware of a problem that occurred with one of our clients. He had inherited a […]

Read More

Endotoxins and Environmental Monitoring for Your Pharmacy, A Review

            Recently, I had the honor and privilege to present a webinar on behalf of the International Academy of Compounding Pharmacists entitled, Endotoxins and Environmental Monitoring for Your Pharmacy. There were over 130 attendees for this webinar that was intended to present the latest information to compounding pharmacists regarding this […]

Read More

20th Annual Napa Pain Conference, William Stuart, RPh

At the 20th Annual Napa Pain Conference, I was fortunate to conduct a presentation at a pre-conference meeting entitled, “Drugs for Intrathecal Administration: Access and Safety.” I began with a discussion of pharmacy provider considerations in order to provide basic relevant criteria for determining a qualified compounding pharmacy provider. Among my topics for consideration was […]

Read More

Performing Due Diligence: Analytical Laboratory Audit

Recently, I went on a fact-finding mission by performing an audit at our quality assurance chemical lab, DynaLabs, located in St. Louis, Missouri. It is an ongoing policy at Hartley Medical to perform due diligence on our suppliers, labs and other vendors to ensure that patient safety is continually at the forefront of our operations […]

Read More

Performing Due Diligence: Site Visits at Hartley Medical

Dr. Chiu (Left) and William Stuart Hartley Medical has written on this topic many times in the past, but today I would like to share two interesting events that occurred over the past two months at Hartley Medical. In November 2012, a prospective pain clinician in Oregon, Dr. Chiu, contacted us. During the phone call, […]

Read More

MAJOR CHALLENGES IN ENVIRONMENTAL MONITORING

My eight-day conference experience began December 3-4, 2012, when I attended the Pharmaceutical Microbiology Forum’s Conference on Environmental Monitoring entitled, “Major Challenges in Environmental Monitoring: A Systems Approach.” This conference presented an overview of USP Chapter <1116> Microbiological Control and Monitoring of Aseptic Processing Environments. I was familiar with this chapter prior to the event; […]

Read More

Did You Know? USP <797> Sterility and Endotoxin Testing

Did You Know? that USP <797> mandates that all high-risk level compounded sterile pharmaceuticals prepared in groups of more than 25 identical individual, single-dose packages or in multiple-dose vials for administration to multiple patients shall meet a sterility test before they are dispensed or administered and that they shall be tested to ensure that they […]

Read More

Quality is Paramount: Performing Due Diligence with Compounding Pharmacies

In light of the recent meningitis outbreak, and due to the overwhelming number of requests made by physicians and medical professionals, Hartley Medical will be hosting a Webinar entitled, “Quality is Paramount: Performing Due Diligence with Compounding Pharmacies.” This Webinar will be held Friday, October 12, 2012 at 8:00 AM PDT (11:00 AM EDT) and […]

Read More

Practice What You Preach! Perform Due Diligence

Due diligence: the act of researching, investigating, and/or auditing to prepare for a potential investment. Many companies encourage their clients and prospective clients to perform due diligence to ensure that they are meeting or, in Hartley Medical’s case, exceeding expectations. However, how many companies actually practice what they preach? Hartley Medical strongly encourages those who […]

Read More

Surface Testing: Setting the Standard for Environmental Monitoring

Here at Hartley Medical, quality is paramount. We go above and beyond the mandates of USP to ensure that our products are compounded at the highest level – a level that guarantees patient safety. One of the many ways we do this is through an environmental monitoring method called microbial surface testing. Surface testing is […]

Read More