Sandoz's Wilson, NC, plant received an August 12 483 from FDA over failure to use proper validation measures for testing lots of its beta-blocker Metoprolol Succinate ER tablets. FDA writes: a) Failures were noted in the process validation studies performed on the Metoprolol Succinate ER 50 mg tablets.
Forget about championing one side or another. The politically charged "generics vs. namebrand drug" debate offers an opportunity to study the impacts of process and ingredient variability on drug manufacturing and on clinical effects in patients. (For material to analyze, click here).
Ensuring patient safety and preventing problems with FDA aren't the only reasons why pharma companies should be meticulous about QA and QC . But quality doesn't only mean the QA and QC that occur within a company's four walls but what happens at contract partner's facilities as well.