Quality Control: An Important Issue in Recent Johnson & Johnson Drug Recall
Pharmaceutical drug manufacturing recalls, like the recent Johnson & Johnson/McNeil plant recall of infant and children’s Tylenol®, Benadryl® and other over-the-counter meds, can cause consumer concern, as well as be detrimental to a company’s financial well being and damage its public image. Marking the fourth recall in the past year, Johnson & Johnson’s production methods are currently under investigation by the House Committee on Oversight and Government Reform.
The reason for this particular recall points to quality control. It’s suspected that the more than 40 pediatric medicines may contain a host of different issues including: a higher concentration of the active ingredient than specified, inactive ingredients that may not meet internal testing requirements, contaminated starting materials and foreign particles.
“From early development stages to scale-up manufacturing and batch releases, quality control needs to be a top priority in the pharmaceutical industry,” said Dr. Ryan Priore, Director of Applications & Contract Services at ChemImage. “We’ve found that the root cause analysis of any failure at its earliest stage greatly benefits manufacturing process control.”
Raman spectroscopy, a non-destructive, vibrational technique often utilized for material identification and characterization in drug development, can also be a valuable tool in ensuring the quality of final formulations. Raman Chemical Imaging (RCI), an approach utilized by ChemImage Contract Services, enables simultaneous spatial (particle size, distribution and shape) and spectral (chemical identification of particles) information which plays a key role in the in vitro measurement of drug product quality.
More specifically, spectroscopy and to some extent chemical imaging multi-modal analytical techniques (Raman, Near-Infrared, Fluorescence and Visible) are ideal for the characterizing of raw materials and final formulations for:
- Purity, homogeneity and content uniformity
- Detection, classification and monitoring of defects, impurities and particulate matter
- Detection and root cause analysis of improper fabrication step in manufacturing
In the end, incorporating RCI imaging technology into the drug development and manufacturing process could save pharmaceutical companies a lot of time and money — ultimately leading to a safer, better quality product.
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