Once again, the specter of contaminated eye drops reaching patients has made headlines. According to the FDA, federal investigators found harmful bacteria and “insanitary conditions” at a factory where several eye drop products are made. The agency said it advised the manufacturer to recall the products.
This is not the first outbreak of contaminated eyedrops. Earlier this year product was found to be contaminated, causing significant harm to patients. A number of patients were treated for a very drug-resistant strain of Pseudomonas aeruginosa. Over 100 patients were blinded in at least one eye, and it caused 4 deaths. Cases were discovered in over 18 states across America.
So what do we do? Following GMP practices will certainly address the issue of contaminated eye drops. The backdrop to the cases above was certainly not following the requirements of GMP, or even the expectations of our industry. Good quality assurance and controls should have, and would very likely have caught this issue before it became critical. Our industry is struggling to fill quality roles, as many technical industries cannot find staff, and where specific skills are required, shortfalls will happen – human nature is not infallible.
At Particle Measuring Systems, we have driven industry standards for the automated monitoring of critical environments, inventing specific products to meet demanding environment and simplifying data management to demonstrate control over contaminated eye drops and other Life Sciences manufacturing environments. Products like FacilityPro Environmental Monitoring System, the Lasair® Pro airborne particle counter for portable monitoring of flow hoods and background areas, and BioCapt® microbial monitors for extended monitoring for microbial contamination, work in unison to shield against errors. Our PMS® Advisory Team of regulatory experts can assist in small or large projects to determine risk and advise on solutions from many sources, reinforcing the current site quality team and bridging knowledge gaps.
