Tag Archives: testing

Pharmaceutical manufacturers can magnify operational efficiency by taking a closer look at on-site quality control processes.

Pharmaceutical manufacturing is all about innovation. The businesses within the industry work diligently to produce effective and accessible medications, as well as medical equipment for patients struggling with illnesses or discomfort. In this way, pharmaceuticals stand apart from other fields of manufacturing. Pharmaceutical can be ingested by customers or, as is the case with hypodermic needles or dialysis machines, connect invasively. As such, raw materials and finished products must be meticulously tested for quality to ensure patients receive healthy treatment doses, and drug manufacturers don’t accidentally introduce microbial pathogens into a patient’s already compromised immune system.

In finding new ways to increase operational efficiency in quality control testing labs for pharmaceutical manufacturers, the industry can enjoy advantages other industries do not – namely, the enhanced ability to save lives. However, these changes must be integrated carefully. Quality control professionals cannot make concessions on rigorously regulated testing assays. That said, finding methods for augmenting how the quality control process is performed – as opposed to the process itself – can yield powerful results in how pharmaceutical manufacturers retain valuable resources and expedite lead times, while still adhering to current good manufacturing practices (cGMP).

“Top performers in pharma had higher success rates with their medications.”

Understanding the value of communication
Before discussing a couple of efficiency measures the pharmaceutical industry could adopt to optimize performance in its clean rooms and testing labs, it is important to first touch on the true value of doing so. Drug companies take an incredible amount of time researching, testing, and producing their wares. A 2014 industry report from the International Federation of Pharmaceutical Manufacturers and Associations stated the time span between the start and end of a drug or vaccines research and development stages could be as much as 10 to 15 years per product. Even though these businesses want to develop as many treatment options as possible to generate a profit and help a widespread audience, they must adhere to all quality control standards, which can legitimately impact the rate of medical innovation.

Pharmaceutical manufacturers with similar time-efficiency issues could benefit from heightened attention to how the communicate inter-departmentally, or rather, how often these department communicate.  Customer demand informs manufacturers on how they should produce and what they should be producing to meet the needs of consumers. As a business within the pharmaceutical industry accelerates its production cycles or scales its market share, data inherently becomes more granular and, indirectly, more volatile if left unchecked. While drug companies toy with the idea of addressing deficiencies in their quality control labs, they should first structure how these departments communicate, especially the frequency with which QC professionals sit down for meetings with other department heads. Weekly conversations, even informal ones, can keep everyone – including the laboratory – abreast of major production crunches or fluctuations in volume that could impact testing. For instance, if an executive announces the future construction of a new clean room in which manufacturing workers can develop treatments, this ultimately means the quality control lab will have an extra area to monitor regularly.

How can manual testing methods receive a performance boost with help from rapid microbiology?

Reducing costs through rapid microbiological methods
Cost reduction in pharmaceutical manufacturing does more than save businesses money – the action can have untold effects on U.S. healthcare. A study published in the Journal of Therapeutic Innovation and Regulatory Science revealed if drug companies decreased manufacturing costs by 30 percent, they could yield anywhere between $1 trillion and $12.3 trillion in social benefits to patients and medical science alike.

“Rapid microbiological equipment automates low-value laboratory labor.”

quality control testing is both a cost- and resource-intensive operation, principally so long as manual, growth-based assay remain the norm. However, the burgeoning field of rapid microbiology has been changing the ways quality control professionals function in a laboratory setting. As the name suggests, rapid microbiology seeks to increase the speed and efficacy with which quality control lab technicians perform their daily duties without altering time-tested compendial culture counting techniques. Additionally, rapid microbiological equipment automates certain low-value laboratory labor to free up technicians and centralize these processes into a single location.

To put rapid microbiological methods (RMM) into context, let’s focus on one specific laboratory activity: moving samples between incubators. Traditionally, lab workers would need to manually move the plates one by one at a predetermined time. Automated equipment could be programmed to execute this task with computer precision without much more than informal oversight.

According to a case study performed by Microbiology Consultants, LLC, a company that expended more than $5.2 million in conventional testing costs saw a nearly 90 percent reduction in operating costs the first year it switched to RMM. It is worth noting a significant portion of this reduction came from negating consumables and disposal costs entirely from the quality control process, thanks to innovative new approaches to sample preparation. Beyond the potential for return on investment (ROI), rapid microbial testing technology and strategies could insure against wasting valuable human capital, protect against contamination, and ultimately, shorten time to release while reinforcing quality control-related cGMP.

Integrating cost and resource efficiency into a pharmaceutical provider’s quality control model will require an unquestionable balance between eliminating waste and upholding best practices for the sake of its patients. Businesses who develop and integrate strong strategies for how to walk that line will benefit greatly.