What food date labels does your company use on the packaging of its products? Right now, there are more than ten commonly used phrases,1 ranging from “sell by” to “freeze by” to “fresh until” to “expires on.” Meanwhile, some food and beverage items are not marked at all. This often […]
Ensuring better-managed stocks of high-quality vaccines is the key to addressing large-scale outbreaks. Image Source: Flickr User CDC Global Health Over the last couple of years, there have been massive outbreaks of nightmarish illnesses such as Zika virus, Ebola, Yellow Fever and the resurgence of both measles and mumps. Many […]
Within the past year, regulatory issues and violations at CMOs have delayed the launch of promising pharmaceuticals. Image Source: Flickr User: ChemieBW Life science firms are expanding well beyond their borders to increase production, and contract manufacturing organizations (CMOs) are popping up everywhere to take on this task. Over the […]
As concerns about the drug manufacturing process grow, pharmaceutical companies must adopt digital solutions that reduce quality variability. Image source: Flickr CC user Michael Chen Last year, the FDA proposed standards for quality metrics and followed that up with guidelines covering data integrity and cGMP compliance. The latter, in particular, […]
In August 2016, NIH released a proposal to reinstate funding for human-animal chimera research—subject to certain stipulations. With a quality strategy in place, labs can ensure that they are in compliance as they conduct cutting-edge disease research using human-animal chimeras.
With attention shifting to data integrity, companies must increasingly be able to guarantee the reliability and accuracy of their quality data. To do otherwise could leave companies vulnerable to data integrity and quality risks that increase their chances of noncompliance.