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 want to do business with us to do their research, request information, obtain quality assurance reports, and even perform a site visit. However, we go above and beyond to obtain the most in-depth reports to present for your consideration. This is why we do more than simply make sure that we are doing everything on our end to ensure that we are providing the highest quality products … we perform due diligence with our suppliers as well!
As integral parts of Hartley Medical’s operations, I make it a priority to perform site visits and inquire into our suppliers’ activities. After all, we at Hartley Medical know that the quality of our products is dependent on the quality of the products we are supplied—and we take no chances with quality!
I recently travelled to Montreal, Canada, to conduct a site visit of one of our chemical suppliers—Medisca. I was fortunate to be accompanied by their national sales manager, Nelson Almeida, as we travelled down to Plattsburgh, New York, to visit their primary repackaging facility for the United States. Here, I had the pleasure of meeting their quality assurance liaison, Yigang Song. I spent nearly three and a half hours with Yigang reviewing the company’s procedures regarding the receipt of products and how they are stored, quarantined, tested, and released for repackaging. We also discussed the repackaging process and the final checks and releases for the active sale and distribution of products. I questioned him on many pertinent aspects of checks and balances for performing quality assurance testing, and assurances of their suppliers as well as their packaging processes. Medisca is the first pharmaceutical supplier that I’ve known with internal check systems to review the products that they receive from their suppliers to maintain a standard of quality that provides the best compounding pharmaceuticals for their clients and their patients.
A major highlight of my conversation with Yigang came from his comment that at the end of the day he knows that his products must meet a certain quality standard; if the product is not something suitable for his own family, then it is not suitable to leave the facility. These types of comments instill me with confidence that I am working with the right supplier.
As I continued to speak with their personnel, and explore their facilities, my assurance in the quality of their products, and subsequently our products as well, was continually confirmed. Quality seems to be ingrained in their employees. I spoke with many of them, and they all realized the importance of their work. It was reassuring to hear the “patient first” mentality.
I was also able to observe the New York facility’s controlled-room environments utilized for repackaging. These contained areas, with dedicated air-filtration systems, feature a six-chambered area that includes a gowning room where the staff members prepare themselves for repackaging. They have a unique, pre-imposed auditing program for cleaning where, prior to repackaging, the rooms are pre-certified and a checklist reviewed to ensure that all parameters governing the room and its environment are met. After repackaging has concluded, there are additional procedures for cleaning the rooms prior to the next repackaging process.
The environments are maintained to restrict entry and exit, and sustain air quality throughout the repackaging process. They have an advanced monitoring system throughout their warehouse and repackaging facility that monitors the temperature and humidity of the multiple locations on a minute-by-minute basis. The result is assurance that they are operating at optimal temperature conditions for repackaging and storage of their pharmaceutical products. If they fall out of specifications at any time, the quality assurance specialist will automatically receive an e-mail and act accordingly.
Medisca’s analytical balances, accompanied by printers, are certified by the manufacturer every three months to assure accuracy. They also own an instrument called a Mal-Vren Particle Meter that has the ability to determine the particle size of pharmaceuticals, and can measure between .1 and 3500 microns in size. This is truly a unique instrument that was purchased because they know their customers demand a specific level of quality of chemicals.
My time spent at Medisca was both educational and enjoyable. It isn’t that often that the core competency of a supplier aligns perfectly with that of your company. My hat is off to Medisca—Hartley Medical operates at a level that is setting the standard for sterile compounding pharmacies, and Medisca seems to operate at a similar level for chemical distributors.
We, at Hartley Medical, are confident that we offer the highest quality sterile pharmaceuticals for improving patients’ quality of life. Why? Because performing due diligence is just one of the many ways we go far beyond the norm to provide the greatest value as a compounding pharmacy—that is the Hartley Standard.
For more information on quality assurance, visit Hartley Medical’s Knowledge Center by clicking here.