Top Stories of 2014
This article was originally published in The Gold Sheet
Readers of “The Gold Sheet” focused more on articles about data integrity than any other topic last year, which is a big reason why data integrity was the No. 1 story of 2014. A number of other highly read articles last year focused on additional topics that were also among the top stories in pharmaceutical manufacturing quality last year.
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The Mind-Numbing Way FDA Uncovers Data Integrity Lapses
An FDA official encourages industry to use this method to audit supply chains for data integrity – even though it can be mind-numbingly tedious.
U.S. Manufacturers Still Favor Three Batches in Process Validation
Despite FDA’s prodding to focus on the science and not the numbers, the pharmaceutical industry still favors a three-batch approach to process validation.
Drug Recalls Soared Again in 2013, Driven by Contamination
FDA reported 1,276 drug recalls last year, the third-highest level ever. Inspections of pharmacies that compounded purportedly aseptic injectables drove the numbers, but pharmaceutical manufacturers also contributed as they struggled with particulates, precipitation and other issues.