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...
As the third and final blog in our Lean Manufacturing Series, we are going to discuss the role that an Enterprise Asset Management (EAM) sys...
As mentioned in the first blog of our Lean Manufacturing Series, lean allows companies to meet FDA regulations and thrive in an increasingly...
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 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 ...
Top 5 Measurable Costs of a Warning Letter
