Takahashi: Look Out for These Data Integrity Issues
This article was originally published in The Gold Sheet
Executive Summary
Are there more data integrity problems in pharmaceutical manufacturing, or is FDA just getting better at finding them? It’s hard to say, says FDA’s Karen Takahashi, who shares what data integrity issues the agency is seeing during inspections and how it’s spotting them.
You may also be interested in...
Hussain: Empowering Workers is the Key to Data Integrity
Why would pharmaceutical quality personnel fib about something like a batch test? Ajaz Hussain, the former FDA’er who helped launch the 21st Century Quality Paradigm, may have found the answer in the science of human behavioral economics.
‘Shadow’ Factory Challenges Continue For US FDA
Agency wants more information about API suppliers as it winds up case against KV Tech for hidden use of Dr. Reddy’s plant and seeks to find disappearing manufacturer of contaminated OTC eye drops.
US FDA, USP Raise Questions About Valisure’s Assertions Of Benzoyl Peroxide’s Benzene Risks
The US drug regulatory authority and standard-setting organization are evaluating the drug-screening venture’s findings regarding stability and potential carcinogenic risks associated with the widely used acne treatment, which includes Rx formulations.