Quality Assurance in Pharmaceuticals: A Vital Necessity

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Introduction

At a recent pharmaceuticals convention, a doctor approached me to express his admiration for our quality assurance technician. He was impressed by our commitment to quality, recognizing it as a rarity in the industry. This encounter filled me with pride but also highlighted a concerning industry reality.

Industry Assumptions vs. Reality

There is a common assumption that all pharmacies are alike and that they adhere to optimal quality and safety standards. Unfortunately, this is far from true. Many pharmacies operate with minimal staff—typically a pharmacist and a few clerks. Few invest in dedicated quality assurance personnel, a crucial oversight given the health stakes involved.

The Hartley Medical Difference

At Hartley Medical, we have recognized the importance of quality assurance for the past seven years. Our quality assurance staff ensures that our compounded preparations are free from bacteria and endotoxins, which are detrimental to human health. Their duties include environmental monitoring for bacteria and viable and non-viable air particulates.

Our Quality Control Instruments

  1. Active Air Sampler
    • This industrial device, akin to a powerful "dust buster," draws 1000 liters of air across a growth plate to assess bio burden. It actively samples air to ensure a clean compounding environment.
  2. Laminar Airflow Workbench (LAFW or IV Hood)
    • This device expels filtered air across a sterile work area defined by plexiglass walls and a hood. Standard models are Class 100, filtering 100 particles at 0.5 microns per cubic foot. We use Class 10, which is ten times cleaner. Our IV hoods are tested and certified every 120 days by an outside lab, exceeding the industry standard of 180 days and far surpassing the pre-2008 standard of annual testing.

Ensuring Sterility

We utilize the IV Hood to guarantee the cleanliness of our sterile preparations. Many practices assume an eternally sterile environment, but this is often not the case. As Ronald Reagan famously said, "Trust, but verify." At Hartley Medical, we live by this motto. Our quality assurance staff constantly verifies our compounding environment to ensure it remains sterile.

The Cost of Quality

Many pharmacies cite cost as a barrier to implementing rigorous quality control measures. However, investing in quality assurance is crucial for business growth and, more importantly, for patient safety. Owners who reinvest in their businesses can achieve higher standards of quality.

Public Awareness

The public often remains unaware of the importance of stringent quality assurance in pharmaceuticals. It is vital for consumers to demand these assurances from their providers.

Conclusion

The commitment to quality assurance is not optional; it is essential. At Hartley Medical, our dedication to controlling and verifying our environment has never wavered, ensuring the purity of our compounding processes. We hope that more pharmacies will recognize the importance of investing in quality assurance for the sake of their patients’ health and safety.