The manufacturing facilities of life science companies can expect to have the U.S. Food and Drug Administration (FDA) show up anytime, annou...
Pharmaceutical compounding as we know today has grown exponentially since its origin – creating greater complexities than ever before. Drug ...
Adherence to cGMPs is vital to all Life Sciences manufacturers and data integrity is one component that impacts cGMP. A corporation’s data i...
Data integrity is vital to success in cGMP manufacturing. Companies can produce safer and higher quality products when they document reliabl...
Culture. With regards to the FDA, this word typically refers to growing microorganisms or other living materials in a medium. You will also ...
In the previous blog, I discussed the importance of using purpose-built software. Because we are a purpose-built EAM solution provider, we s...
Now that we’ve covered broader GMP issues in the previous 3 blogs, I want to discuss the overall role of an EAM/CMMS in managing compliance ...
In the previous blog in this series, I discussed the FDA’s new Office of Pharmaceutical Quality and its overarching goals. There is no bette...
The Office of Pharmaceutical Quality (OPQ), launched in 2015, will be used to carry out the FDA’s long term plan to establish a uniform qual...
In our previous blog series, we briefly explored the growing enforcement of the FDA. From 2007 to 2012, the number of warning letters given ...
